Comparison of Topical Lidocaine Spray With Placebo for Pain Relief in Colposcopic Procedures: A Randomized, Placebo-Controlled, Double-Blind Study Murat Öz, MD, Elmas Korkmaz, MD, Nilufer Cetinkaya, MD, Sevda Baş, MD, Bülent Özdal, MD, Mehmet Mutlu Meydanlı, Assoc. Prof., and Tayfun Güngör, Assoc. Prof. Objective: To compare the effectiveness of topical lidocaine spray compared to a placebo for relieving pain during colposcopic cervical biopsies and endocervical curettage. Methods: This randomized, placebo-controlled, double-blind study included patients with abnormal cervical cytologic results requiring colposcopy and directed cervical punch biopsy with or without endocervical curettage (ECC). The patients were randomly assigned to either the 10% lidocaine spray or the placebo group. The patients were asked to rate the pain level immediately after the cervical biopsy and ECC, and mean pain scores of the 2 groups were compared. Results: A total of 214 women were included in the study: 104 in the lidocaine group and 110 in the control group. Age, parity, and history of previous vaginal delivery and cesarean section were similar in both groups. Mean ± SD age was 41.5 ± 10.6 years in the lidocaine group and 43 ± 11.3 years in the control group. Pain scores after cervical biopsy and ECC were also similar between the 2 groups. Mean ± SD pain scores associated with cervical biopsy were 2.18 ± 1.7 in the lidocaine group and 2.31 ± 1.6 in the control group. Discussion and Conclusion: In our population, there is no evidence to recommend the use of routine locally sprayed lidocaine anesthesia before cervical punch biopsy or ECC. Key Words: colposcopy, pain relief, punch biopsy, local anesthesia, lidocaine (J Lower Gen Tract Dis 2015;19: 212–214)
I
n general practice, cervical biopsies are often performed without anesthesia; patients often wonder whether this procedure will be done under anesthesia or even request it. In some institutions, no anesthetic is introduced before cervical punch biopsy. Several studies have investigated the efficacy of various types of anesthesia and analgesia including benzocaine gel,1,2 ibuprofen,3 topical benzocaine spray,4 topical lignocaine gel,5 lidocaine infiltration anesthesia,6,7 prilocaine and felypressin infiltration anesthesia.8 In addition, several investigators proposed the use of nonpharmacological techniques such as counterstimulation, hypnosis, or distraction to relieve pain during cervical biopsies.9,10 To date, no randomized, double-blind, placebo-controlled study has been conducted to investigate the efficacy of topical lidocaine spray to ease pain during cervical biopsy procedures. This study evaluates the effectiveness of topical lidocaine spray compared to
Department of Gynaecological Oncology, Zekai Tahir Burak Women's Health Hospital, Ankara, Turkey Reprint requests to: Murat Öz, MD, Zekai Tahir Burak Women's Health Hospital, Talatpasa Blvd. Altindag/Ankara, Turkey. E-mail: [email protected] Financial support: none The local institutional ethical board approved this study (approval number 26.12.2013-24). The authors certify that no conflict of interest in relation to this article exists. © 2015, American Society for Colposcopy and Cervical Pathology
212
placebo in relieving pain during colposcopic cervical punch biopsies and endocervical curettage (ECC).
MATERIALS AND METHODS This randomized, placebo-controlled, double-blind study was conducted in Zekai Tahir Burak Women's Health Hospital Department of Gynecologic Oncology between December 2013 and April 2014. The study was approved by the local institutional ethical board (approval number 26.12.2013–24), and detailed written informed consent was obtained from each participant. Women with abnormal cervical cytologic results requiring colposcopy and colposcopically directed cervical biopsy with or without ECC were included in the study. Patients were assigned to either a group receiving 10% lidocaine solution (Vemcaine Pump Spray 10%, Nobel Farma, Turkey) or another group receiving sterile saline solution in an identical pump spray container. Each patient encounter was conducted in the same room and by the same colposcopist (M.O.) to maintain consistency and limit variation. Cervical biopsies are performed using punch biopsy forceps under binocular colposcopic examination with a depth enough to include surface epithelium with underlying stroma. We tried to keep the number of biopsies at minimum; no random or blind biopsies were performed. Randomization was carried out using a sealed envelope system. Participants were asked to choose an opaque envelope in which the treatment allocation was assigned. The colposcopist was blinded to the randomization and was provided the appropriate testing media based on the patients' choice. Exclusion criteria were being allergic to lidocaine, younger than age 18, having a grossly visible cervical lesion, currently pregnant, and unable to read or speak Turkish. Depending on the group assignment, either 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) or 5 pumps of sterile saline were applied to the ectocervix, and the colposcopist waited for 2 minutes before acetic acid application. Biopsy sites were determined under colposcopic examination. Patient pain scores were measured using the Wong-Baker FACES Pain Rating Scale, and the women were asked to rate their pain levels immediately after the punch biopsy and after the ECC. The pain score after the first cervical biopsy was noted if multiple biopsies were taken. Basic demographic and clinical information, including age, educational level, parity, and numbers of cesarean or vaginal births were collected before the procedure. Sample size calculations showed we would need 92 women randomized to each group to have 95% power with 5% type 1 error with an estimated decrease in the pain score of more than 1 in patients receiving local anesthetic and a within group standard deviation of 2, using G*Power 3.1 software (Universitat Düsseldorf, Düsseldorf, Germany). To compensate for potential exclusion or dropout after recruitment, we enrolled 15% more patients for each group. Statistical analysis was performed with the SPSS computer software (version 22 for Macintosh; SPSS, Chicago, IL). Normal distribution of the continuous variables was evaluated
Journal of Lower Genital Tract Disease • Volume 19, Number 3, July 2015
Copyright © 2015 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
Journal of Lower Genital Tract Disease • Volume 19, Number 3, July 2015
3.7 ± 2.2 in the control group. A Mann-Whitney U test showed no significant difference between the mean pain scores for biopsy and ECC in the 2 study arms (Table 2). The Spearman correlation test suggested an overall inverse relationship between educational level and pain score. Patients' pain scores decreased with increasing levels of education (Table 3).
TABLE 1. Preceding Cervical Cytologic Results of the Patients Lidocaine arm (n)
Control arm (n)
83 10 5 4 2 104
82 19 4 3 2 110
ASC-US L-SIL AGUS ASC-H H-SIL TOTAL
Effectiveness of Topical Lidocaine Spray
DISCUSSION The mean pain scores associated with cervical biopsy and ECC noted here are slightly lower than for other studies in the literature. The earliest study, by Rabin et al.,2 which investigated the use of topical anesthesia for gynecologic procedures, compared benzocaine 20% gel with placebo for its ability to reduce pain associated with cervical biopsy, intrauterine device insertion, ECC, paracervical block, and tenaculum placement. In that study, benzocaine 20% gel significantly reduced pain associated with vaginal procedures. Then Church et al.3 concluded that topical benzocaine gel alone or together with oral ibuprofen did not relieve the pain related with cervical punch biopsy. Conflicting results may be due to difference in the total amount of anesthetic gel applied to the cervix and upper vagina before the cervical biopsy. In the latter study, only 2 mL of benzocaine 20% topical gel was applied to the cervix for 2 minutes; but it is known that the anesthetic effect of the benzocaine gel occurs after 5 minutes and lasts for 20 to 30 minutes. The application of larger amount of anesthetic gel to the cervix and upper vagina can theoretically enhance the anesthetic effect and provide additional protection against pain caused by cervical procedures. Clifton et al.4 indicated the “ineffectiveness of topical benzocaine spray during colposcopy” in their double-blind, placebo-controlled prospective study; but the power of the study is insufficient to make a definitive conclusion owing to small numbers (36 participants). In a well-designed, placebo-controlled prospective study investigating the efficacy of xylocaine gel, the authors concluded that pretreatment with xylocaine gel was ineffective in relieving the pain associated with cervical punch biopsy.5 In addition to these data, the authors stated that the overall pain score was, however, associated with the anticipated pain score. Anticipated pain score may be affected by several situations such as educational level, obstetric history, chronic pelvic pain, or dysmenorrhea. We found a significant inverse relationship between patients' educational level and reported pain scores after both cervical biopsy and ECC procedures. Obstetric history and number of previous vaginal births were not relevant to pain scores. In the light of these results, we believe that informative discussion before colposcopy and patients' comprehension of the procedure is important in improving the anticipated and overall pain scores related to the procedure. Oyama et al.1 studied infiltration anesthesia to the cervix (paracervical block) with 0.5-mL lidocaine 1% injection and
ASC-US indicates atypical squamous cells of undetermined significance; L-SIL, low-grade squamous intraepithelial lesion; AGUS, atypical glandular cells of undetermined significance; ASC-H, atypical squamous cells; H-SIL, high-grade squamous intraepithelial lesion.
by the Kolmogorov-Smirnov test. The Mann-Whitney U test was used for comparison of the means because the pain scores of the groups were skewed and not normally distributed. Ninety-five percent confidence intervals for the median difference in pain scores between the 2 groups were computed. While investigating the associations between nonnormally distributed or ordinal variables, the correlation coefficients and their significance were calculated using the Spearman test, where p < .05 was considered statistically significant.
RESULTS Two hundred thirty women were enrolled in the study, 16 of which were excluded from analysis according to the exclusion criteria. We randomized 104 women to the treatment arm and 110 to the control arm. One hundred four cervical biopsies and 102 ECCs were performed in the lidocaine group; and 110 biopsies and 108 ECCs were performed in the control group. Colposcopy was indicated for equivocal or abnormal cytologic results according to the 2001 Bethesda system update,11 and colposcopy indications are summarized in Table 1. Distribution of colposcopy indications between the 2 groups was similar. All procedures were successfully completed without complications or serious adverse reaction such as heavy bleeding or allergic reaction to the lidocaine. Age, parity, and history of previous vaginal delivery and cesarean section among the 3 groups were comparable. Mean ± SD age was 41.5 ± 10.6 in the lidocaine group and 43 ± 11.3 years in the control group. Pain scores after cervical biopsy and ECC were comparable in both study arms. Mean± SD pain scores associated with cervical biopsy were 2.18 ± 1.7 in the lidocaine group and 2.31 ± 1.6 in the control group. Pain associated with an ECC was slightly higher: 3.68 ± 2.2 in the lidocaine group and
TABLE 2. Demographic and Clinical Characteristics of the Groups
Age, mean ± SD, yrs Parity, mean ± SD History of previous vaginal delivery, mean ± SD History of previous cesarean section, mean ± SD Pain scores after cervical biopsy, mean ± SD Pain scores after ECC, mean ± SD
Lidocaine arm
Control arm
pa
41.5 ± 10.6 2.1 ± 1.4 1.9 ± 1.5 0.2 ± 0.5 2.2 ± 1.7 3.7 ± 2.2
43 ± 11.3 2.3 ± 1.4 2.1 ± 1.5 0.2 ± 0.6 2.3 ± 1.6 3.7 ± 2.2
.3 .3 .3 .6 .3 .8
a
Mann-Whitney U test.
© 2015, American Society for Colposcopy and Cervical Pathology
213
Copyright © 2015 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
Journal of Lower Genital Tract Disease • Volume 19, Number 3, July 2015
Öz et al.
TABLE 3. Correlation Between Educational Level of Patients and Pain Scores Educational level
Biopsy pain scores (total number; mean ± SD)
Primary school Secondary school High school University pa
N = 107; 2.4 ± 1.7 N = 25; 2.9 ± 1.8 N = 50; 2 ± 1.6 N = 32; 1.8 ± 1.7 .03
ECC pain scores (total number; mean ± SD) N = 106; 3.9 ± 2 N = 25; 4.6 ± 2.1 N = 49; 3.2 ± 2 N = 30; 3 ± 2.3 .014
a
Spearman correlation test.
found a significant reduction in pain scores in their study group. A major limitation of that study was the lack of a placebo control group. Patients receiving lidocaine injection were aware that they received “the medicine,” causing a major bias in the pain perception of the individuals. Cervical injection may also cause additional pain and bleeding according to the number of injections and may interfere with the colposcopic inspection and even with histopathologic study. These disadvantages for infiltration anesthesia would not be seen with topical agents. The most important benefit of lidocaine injection to the cervix seems to be reducing the pain associated with ECC. Schmid et al.7 used a distraction method, forced coughing, at the moment of colposcopically directed biopsy as pain relief and compared it with 1% lidocaine injection to the cervix. They could not demonstrate a statistical difference between the 2 methods, assuming that the distraction method is as effective as lidocaine injection, based on the results of the study that Oyama et al. conducted. However, Naki et al.6 were unable to demonstrate the superiority of the forced coughing method over control group. They also pointed out that lidocaine injection to the cervix causes additional pain before biopsy and prolongs the procedure about 1.1 minutes. Patients feel a considerable amount of pain during cervical biopsy and ECC procedures. Since the uterine cervix has visceral innervation, local anesthesia techniques tend to be ineffective in decreasing the pain associated with colposcopic procedures. We noted that patient's educational level and understanding of the procedure helps to decrease the pain scores, and we believe that the perception of pain decreases significantly if the patient is informed enough about the steps of the procedure. This is a prospective, randomized, double-blind, placebocontrolled study; and the number of patients in each arm is enough to achieve a significant difference between placebo and topical lidocaine spray in decreasing pain associated with colposcopic procedures. The main limitation of the study is that we could not determine whether the lidocaine spray application interferes with the acetowhite characteristics (borders, duration, and opacity) of the epithelium because the colposcopist was blinded to the medium and we did not note the time period from acetowhite appearance to the fade-out. In conclusion, studies regarding the use of local anesthesia during cervical punch biopsy procedures have conflicting results.
214
There is little evidence to recommend routine sprayed anesthetics before cervical punch biopsy or ECC.
REFERENCES 1. Oyama IA, Wakabayashi MT, Frattarelli LC, Kessel B. Local anesthetic reduces the pain of colposcopic biopsies: a randomized trial. Am J Obstet Gynecol 2003;188:1164–5. 2. Rabin JM, Spitzer M, Dwyer AT, Kaiser IH. Topical anesthesia for gynecologic procedures. Obstet Gynecol 1989;73:1040–4. 3. Church L, Oliver L, Dobie S, Madigan D, Ellsworth A. Analgesia for colposcopy: double-masked, randomized comparison of ibuprofen and benzocaine gel. Obstet Gynecol 2001;97:5–10. 4. Clifton PA, Shaughnessy AF, Andrews S. Ineffectiveness of topical benzocaine spray during colposcopy. J Fam Pract 1998;46:242–6. 5. Wong GC, Li RH, Wong TS, Fan SY. The effect of topical lignocaine gel in pain relief for colposcopic assessment and biopsy: is it useful? BJOG 2008; 115:1057–60. 6. Naki MM, Api O, Acioglu HC, Uzun MG, Kars B, Unal O. Analgesic efficacy of forced coughing versus local anesthesia during cervical punch biopsy. Gynecol Obstet Invest 2011;72:5–9. 7. Schmid BC, Pils S, Heinze G, Hefler L, Reinthaller A, Speiser P. Forced coughing versus local anesthesia and pain associated with cervical biopsy: a randomized trial. Am J Obstet Gynecol 2008;199:641.e1–641.e3. 8. Duncan ID, McKinley CA, Pinion SB, Wilson SM. A double-blind, randomized, placebo-controlled trial of prilocaine and felypressin (Citanest and Octapressin) for the relief of pain associated with cervical biopsy and treatment with the Semm coagulator. J Low Genit Tract Dis 2005;9:171–5. 9. Riley JF, Levine FM. Counterstimulation and pain perception: effects of electrocutaneous vs. auditory stimulation upon cold pressor pain. Pain 1988;35:259–64. 10. Frenay MC, Faymonville ME, Devlieger S, Albert A, Vanderkelen A. Psychological approaches during dressing changes of burned patients: a prospective randomised study comparing hypnosis against stress reducing strategy. Burns 2001;27:793–9. 11. Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, et al. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002;287:2114–9.
© 2015, American Society for Colposcopy and Cervical Pathology
Copyright © 2015 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
I
n general practice, cervical biopsies are often performed without anesthesia; patients often wonder whether this procedure will be done under anesthesia or even request it. In some institutions, no anesthetic is introduced before cervical punch biopsy. Several studies have investigated the efficacy of various types of anesthesia and analgesia including benzocaine gel,1,2 ibuprofen,3 topical benzocaine spray,4 topical lignocaine gel,5 lidocaine infiltration anesthesia,6,7 prilocaine and felypressin infiltration anesthesia.8 In addition, several investigators proposed the use of nonpharmacological techniques such as counterstimulation, hypnosis, or distraction to relieve pain during cervical biopsies.9,10 To date, no randomized, double-blind, placebo-controlled study has been conducted to investigate the efficacy of topical lidocaine spray to ease pain during cervical biopsy procedures. This study evaluates the effectiveness of topical lidocaine spray compared to
Department of Gynaecological Oncology, Zekai Tahir Burak Women's Health Hospital, Ankara, Turkey Reprint requests to: Murat Öz, MD, Zekai Tahir Burak Women's Health Hospital, Talatpasa Blvd. Altindag/Ankara, Turkey. E-mail: [email protected] Financial support: none The local institutional ethical board approved this study (approval number 26.12.2013-24). The authors certify that no conflict of interest in relation to this article exists. © 2015, American Society for Colposcopy and Cervical Pathology
212
placebo in relieving pain during colposcopic cervical punch biopsies and endocervical curettage (ECC).
MATERIALS AND METHODS This randomized, placebo-controlled, double-blind study was conducted in Zekai Tahir Burak Women's Health Hospital Department of Gynecologic Oncology between December 2013 and April 2014. The study was approved by the local institutional ethical board (approval number 26.12.2013–24), and detailed written informed consent was obtained from each participant. Women with abnormal cervical cytologic results requiring colposcopy and colposcopically directed cervical biopsy with or without ECC were included in the study. Patients were assigned to either a group receiving 10% lidocaine solution (Vemcaine Pump Spray 10%, Nobel Farma, Turkey) or another group receiving sterile saline solution in an identical pump spray container. Each patient encounter was conducted in the same room and by the same colposcopist (M.O.) to maintain consistency and limit variation. Cervical biopsies are performed using punch biopsy forceps under binocular colposcopic examination with a depth enough to include surface epithelium with underlying stroma. We tried to keep the number of biopsies at minimum; no random or blind biopsies were performed. Randomization was carried out using a sealed envelope system. Participants were asked to choose an opaque envelope in which the treatment allocation was assigned. The colposcopist was blinded to the randomization and was provided the appropriate testing media based on the patients' choice. Exclusion criteria were being allergic to lidocaine, younger than age 18, having a grossly visible cervical lesion, currently pregnant, and unable to read or speak Turkish. Depending on the group assignment, either 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) or 5 pumps of sterile saline were applied to the ectocervix, and the colposcopist waited for 2 minutes before acetic acid application. Biopsy sites were determined under colposcopic examination. Patient pain scores were measured using the Wong-Baker FACES Pain Rating Scale, and the women were asked to rate their pain levels immediately after the punch biopsy and after the ECC. The pain score after the first cervical biopsy was noted if multiple biopsies were taken. Basic demographic and clinical information, including age, educational level, parity, and numbers of cesarean or vaginal births were collected before the procedure. Sample size calculations showed we would need 92 women randomized to each group to have 95% power with 5% type 1 error with an estimated decrease in the pain score of more than 1 in patients receiving local anesthetic and a within group standard deviation of 2, using G*Power 3.1 software (Universitat Düsseldorf, Düsseldorf, Germany). To compensate for potential exclusion or dropout after recruitment, we enrolled 15% more patients for each group. Statistical analysis was performed with the SPSS computer software (version 22 for Macintosh; SPSS, Chicago, IL). Normal distribution of the continuous variables was evaluated
Journal of Lower Genital Tract Disease • Volume 19, Number 3, July 2015
Copyright © 2015 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
Journal of Lower Genital Tract Disease • Volume 19, Number 3, July 2015
3.7 ± 2.2 in the control group. A Mann-Whitney U test showed no significant difference between the mean pain scores for biopsy and ECC in the 2 study arms (Table 2). The Spearman correlation test suggested an overall inverse relationship between educational level and pain score. Patients' pain scores decreased with increasing levels of education (Table 3).
TABLE 1. Preceding Cervical Cytologic Results of the Patients Lidocaine arm (n)
Control arm (n)
83 10 5 4 2 104
82 19 4 3 2 110
ASC-US L-SIL AGUS ASC-H H-SIL TOTAL
Effectiveness of Topical Lidocaine Spray
DISCUSSION The mean pain scores associated with cervical biopsy and ECC noted here are slightly lower than for other studies in the literature. The earliest study, by Rabin et al.,2 which investigated the use of topical anesthesia for gynecologic procedures, compared benzocaine 20% gel with placebo for its ability to reduce pain associated with cervical biopsy, intrauterine device insertion, ECC, paracervical block, and tenaculum placement. In that study, benzocaine 20% gel significantly reduced pain associated with vaginal procedures. Then Church et al.3 concluded that topical benzocaine gel alone or together with oral ibuprofen did not relieve the pain related with cervical punch biopsy. Conflicting results may be due to difference in the total amount of anesthetic gel applied to the cervix and upper vagina before the cervical biopsy. In the latter study, only 2 mL of benzocaine 20% topical gel was applied to the cervix for 2 minutes; but it is known that the anesthetic effect of the benzocaine gel occurs after 5 minutes and lasts for 20 to 30 minutes. The application of larger amount of anesthetic gel to the cervix and upper vagina can theoretically enhance the anesthetic effect and provide additional protection against pain caused by cervical procedures. Clifton et al.4 indicated the “ineffectiveness of topical benzocaine spray during colposcopy” in their double-blind, placebo-controlled prospective study; but the power of the study is insufficient to make a definitive conclusion owing to small numbers (36 participants). In a well-designed, placebo-controlled prospective study investigating the efficacy of xylocaine gel, the authors concluded that pretreatment with xylocaine gel was ineffective in relieving the pain associated with cervical punch biopsy.5 In addition to these data, the authors stated that the overall pain score was, however, associated with the anticipated pain score. Anticipated pain score may be affected by several situations such as educational level, obstetric history, chronic pelvic pain, or dysmenorrhea. We found a significant inverse relationship between patients' educational level and reported pain scores after both cervical biopsy and ECC procedures. Obstetric history and number of previous vaginal births were not relevant to pain scores. In the light of these results, we believe that informative discussion before colposcopy and patients' comprehension of the procedure is important in improving the anticipated and overall pain scores related to the procedure. Oyama et al.1 studied infiltration anesthesia to the cervix (paracervical block) with 0.5-mL lidocaine 1% injection and
ASC-US indicates atypical squamous cells of undetermined significance; L-SIL, low-grade squamous intraepithelial lesion; AGUS, atypical glandular cells of undetermined significance; ASC-H, atypical squamous cells; H-SIL, high-grade squamous intraepithelial lesion.
by the Kolmogorov-Smirnov test. The Mann-Whitney U test was used for comparison of the means because the pain scores of the groups were skewed and not normally distributed. Ninety-five percent confidence intervals for the median difference in pain scores between the 2 groups were computed. While investigating the associations between nonnormally distributed or ordinal variables, the correlation coefficients and their significance were calculated using the Spearman test, where p < .05 was considered statistically significant.
RESULTS Two hundred thirty women were enrolled in the study, 16 of which were excluded from analysis according to the exclusion criteria. We randomized 104 women to the treatment arm and 110 to the control arm. One hundred four cervical biopsies and 102 ECCs were performed in the lidocaine group; and 110 biopsies and 108 ECCs were performed in the control group. Colposcopy was indicated for equivocal or abnormal cytologic results according to the 2001 Bethesda system update,11 and colposcopy indications are summarized in Table 1. Distribution of colposcopy indications between the 2 groups was similar. All procedures were successfully completed without complications or serious adverse reaction such as heavy bleeding or allergic reaction to the lidocaine. Age, parity, and history of previous vaginal delivery and cesarean section among the 3 groups were comparable. Mean ± SD age was 41.5 ± 10.6 in the lidocaine group and 43 ± 11.3 years in the control group. Pain scores after cervical biopsy and ECC were comparable in both study arms. Mean± SD pain scores associated with cervical biopsy were 2.18 ± 1.7 in the lidocaine group and 2.31 ± 1.6 in the control group. Pain associated with an ECC was slightly higher: 3.68 ± 2.2 in the lidocaine group and
TABLE 2. Demographic and Clinical Characteristics of the Groups
Age, mean ± SD, yrs Parity, mean ± SD History of previous vaginal delivery, mean ± SD History of previous cesarean section, mean ± SD Pain scores after cervical biopsy, mean ± SD Pain scores after ECC, mean ± SD
Lidocaine arm
Control arm
pa
41.5 ± 10.6 2.1 ± 1.4 1.9 ± 1.5 0.2 ± 0.5 2.2 ± 1.7 3.7 ± 2.2
43 ± 11.3 2.3 ± 1.4 2.1 ± 1.5 0.2 ± 0.6 2.3 ± 1.6 3.7 ± 2.2
.3 .3 .3 .6 .3 .8
a
Mann-Whitney U test.
© 2015, American Society for Colposcopy and Cervical Pathology
213
Copyright © 2015 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
Journal of Lower Genital Tract Disease • Volume 19, Number 3, July 2015
Öz et al.
TABLE 3. Correlation Between Educational Level of Patients and Pain Scores Educational level
Biopsy pain scores (total number; mean ± SD)
Primary school Secondary school High school University pa
N = 107; 2.4 ± 1.7 N = 25; 2.9 ± 1.8 N = 50; 2 ± 1.6 N = 32; 1.8 ± 1.7 .03
ECC pain scores (total number; mean ± SD) N = 106; 3.9 ± 2 N = 25; 4.6 ± 2.1 N = 49; 3.2 ± 2 N = 30; 3 ± 2.3 .014
a
Spearman correlation test.
found a significant reduction in pain scores in their study group. A major limitation of that study was the lack of a placebo control group. Patients receiving lidocaine injection were aware that they received “the medicine,” causing a major bias in the pain perception of the individuals. Cervical injection may also cause additional pain and bleeding according to the number of injections and may interfere with the colposcopic inspection and even with histopathologic study. These disadvantages for infiltration anesthesia would not be seen with topical agents. The most important benefit of lidocaine injection to the cervix seems to be reducing the pain associated with ECC. Schmid et al.7 used a distraction method, forced coughing, at the moment of colposcopically directed biopsy as pain relief and compared it with 1% lidocaine injection to the cervix. They could not demonstrate a statistical difference between the 2 methods, assuming that the distraction method is as effective as lidocaine injection, based on the results of the study that Oyama et al. conducted. However, Naki et al.6 were unable to demonstrate the superiority of the forced coughing method over control group. They also pointed out that lidocaine injection to the cervix causes additional pain before biopsy and prolongs the procedure about 1.1 minutes. Patients feel a considerable amount of pain during cervical biopsy and ECC procedures. Since the uterine cervix has visceral innervation, local anesthesia techniques tend to be ineffective in decreasing the pain associated with colposcopic procedures. We noted that patient's educational level and understanding of the procedure helps to decrease the pain scores, and we believe that the perception of pain decreases significantly if the patient is informed enough about the steps of the procedure. This is a prospective, randomized, double-blind, placebocontrolled study; and the number of patients in each arm is enough to achieve a significant difference between placebo and topical lidocaine spray in decreasing pain associated with colposcopic procedures. The main limitation of the study is that we could not determine whether the lidocaine spray application interferes with the acetowhite characteristics (borders, duration, and opacity) of the epithelium because the colposcopist was blinded to the medium and we did not note the time period from acetowhite appearance to the fade-out. In conclusion, studies regarding the use of local anesthesia during cervical punch biopsy procedures have conflicting results.
214
There is little evidence to recommend routine sprayed anesthetics before cervical punch biopsy or ECC.
REFERENCES 1. Oyama IA, Wakabayashi MT, Frattarelli LC, Kessel B. Local anesthetic reduces the pain of colposcopic biopsies: a randomized trial. Am J Obstet Gynecol 2003;188:1164–5. 2. Rabin JM, Spitzer M, Dwyer AT, Kaiser IH. Topical anesthesia for gynecologic procedures. Obstet Gynecol 1989;73:1040–4. 3. Church L, Oliver L, Dobie S, Madigan D, Ellsworth A. Analgesia for colposcopy: double-masked, randomized comparison of ibuprofen and benzocaine gel. Obstet Gynecol 2001;97:5–10. 4. Clifton PA, Shaughnessy AF, Andrews S. Ineffectiveness of topical benzocaine spray during colposcopy. J Fam Pract 1998;46:242–6. 5. Wong GC, Li RH, Wong TS, Fan SY. The effect of topical lignocaine gel in pain relief for colposcopic assessment and biopsy: is it useful? BJOG 2008; 115:1057–60. 6. Naki MM, Api O, Acioglu HC, Uzun MG, Kars B, Unal O. Analgesic efficacy of forced coughing versus local anesthesia during cervical punch biopsy. Gynecol Obstet Invest 2011;72:5–9. 7. Schmid BC, Pils S, Heinze G, Hefler L, Reinthaller A, Speiser P. Forced coughing versus local anesthesia and pain associated with cervical biopsy: a randomized trial. Am J Obstet Gynecol 2008;199:641.e1–641.e3. 8. Duncan ID, McKinley CA, Pinion SB, Wilson SM. A double-blind, randomized, placebo-controlled trial of prilocaine and felypressin (Citanest and Octapressin) for the relief of pain associated with cervical biopsy and treatment with the Semm coagulator. J Low Genit Tract Dis 2005;9:171–5. 9. Riley JF, Levine FM. Counterstimulation and pain perception: effects of electrocutaneous vs. auditory stimulation upon cold pressor pain. Pain 1988;35:259–64. 10. Frenay MC, Faymonville ME, Devlieger S, Albert A, Vanderkelen A. Psychological approaches during dressing changes of burned patients: a prospective randomised study comparing hypnosis against stress reducing strategy. Burns 2001;27:793–9. 11. Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, et al. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002;287:2114–9.
© 2015, American Society for Colposcopy and Cervical Pathology
Copyright © 2015 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
