Arch Gynecol Obstet DOI 10.1007/s00404-014-3186-8
General Gynecology
Effect of local infiltration analgesia on post‑operative pain following TVT‑O: a double‑blind, placebo‑controlled randomized study Giovanni A. Tommaselli · Costantino Di Carlo · Carmen Formisano · Annamaria Fabozzi · Carmine Nappi
Received: 28 November 2013 / Accepted: 12 February 2014 © Springer-Verlag Berlin Heidelberg 2014
Abstract Purpose To evaluate the effect of a protocol of local anesthesia and epinephrine associated with sedo-analgesia on post-TVT-O pain in comparison with infiltration of saline and epinephrine. Methods Forty-two patients undergoing TVT-O were randomized into two groups to receive periurethral infiltration with epinephrine only (group A, n = 21) or with epinephrine plus 1 % lidocaine hydrochloride (group B, n = 21). Post-operative pain was assessed using a visual analog scale (VAS) from 0 (absence of pain) to 10 (maximum pain possible), 1, 6, 12 and 24 h after the procedure. The total amount of analgesia was recorded and the proportion of women reporting a pain VAS score ≥4, 1 h after the procedure was calculated. ANOVA for repeated measures and Bonferroni correction, the Student’s t test for independent samples, the Mann–Whitney U test, the Fisher exact test, or the χ2 test for parametric was used. Results Pain level was significantly lower in group B 1 (p = 0.01) and 6 h (p = 0.05) after surgery, but not 12 and 24 h after the procedure. No significant difference was observed in the proportion of women requesting analgesia and in the total dosage of analgesics between the two groups. A significant higher proportion of women in group A reported a pain VAS score higher than four 1 h after surgery in comparison with patients in group B.
G. A. Tommaselli (*) · C. Di Carlo · C. Formisano · A. Fabozzi · C. Nappi Department of Neuroscience and Reproductive and Odontostomatologic Sciences, University of Naples “Federico II”, Via S. Pansini, 5, 80131 Naples, Italy e-mail: [email protected]
Conclusions This randomized study seems to indicate that systematic infiltration before TVT-O positioning with local anesthetic may reduce immediate post-operative pain. Keywords Local analgesia · Post-operative pain · Stress urinary incontinence · TVT-O
Introduction The transobturator approach, both inside-out and outsidein, for the positioning of midurethral sling has become widely used for the surgical treatment of female stress urinary incontinence (SUI) [1, 2]. It yields similar objective and subjective cure rates in comparison with retropubic TVT and implies a lower risk of organ and vessel injuries [3, 4]. Nevertheless, this technique has been associated with a higher rate and intensity of post-operative pain [5]. The aim of surgery for SUI in the last years has been to further reduce invasiveness. With this aim, single-incision devices were introduced to avoid the passage through the retropubic space or the obturator foramen and to reduce complications, post-operative pain, and the return to daily activities and to work [6]. Data on the effectiveness of these devices are still limited and controversial [6, 7]. For these reasons, the possibility of reducing post-operative pain using transobturator devices has been further investigated. de Leval and co-workers [8] recently introduced a new inside-out transobturator device with a shortened tape that proved to have the same mid-term effectiveness as the original TVT-O, while reducing post-operative pain [9]. Neuman et al. [10] suggested a modification of the original TVT-O technique with a medial deviation, passing perpendicularly through the medial part of the obturator
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Arch Gynecol Obstet
membrane and muscles, in an attempt to cause less tissue damage and reduce post-operative pain. This modification has been demonstrated to reduce both the intensity and duration of post-operative pain in comparison to the original technique [11]. Our group recently demonstrated that post-operative pain was significantly reduced using a slight modification of the original TVT-O, with less paraurethral dissection, avoidance of perforating the obturator membrane with the scissors or the guide, and using a more medial trajectory of the trocars [12, 13]. Infiltration of the operative site with local anesthesia is a well-established procedure for post-operative analgesia across procedures [14–17], widely used in urogynecology and easy to perform, but there are no reports on its efficacy on post-operative pain after TVT-O. The aim of this double-blind, placebo-controlled, randomized study was to assess if a standardized protocol of local anesthesia and epinephrine associated with sedoanalgesia is associated with a lower post-operative pain after TVT-O in comparison with infiltration of saline and epinephrine.
Materials and methods This double-blind, placebo-controlled, randomized study was performed in the urogynecological unit of our
Fig. 1 Flow of patient throughout the study
institution. From January 2011 to September 2011, 78 patients affected by stress urinary incontinence (SUI) were evaluated for inclusion in the study. Inclusion criteria were: SUI as diagnosed by clinical evaluation and urodynamics, age >30 years, and previously failed pelvic floor muscle training. Exclusion criteria were: previous surgery for SUI, isolated overactive bladder symptoms, pelvic organ prolapse ≥ POP stage II, presence of neurological disease, sensitivity to local anesthetics, paracetamol or tramadol, and serious contraindications to surgical procedures. The study was approved by the Institutional Review Board of our institution and all patients gave informed consent to participate in the study. As requested by the Consolidated Standards of Reporting Trials (CONSORT), the flow of patients throughout the study is illustrated in Fig. 1. Fifty patients satisfied the inclusion criteria, but eight refused to undergo the randomization process and were thus excluded from the study. The remaining 42 patients were randomized into two groups in a 1:1 ratio using a randomization list generated by a computer. All patients were scheduled to undergo the midurethral sling procedure using the TVT-O device (Ethicon Gynecare, Somerville, NJ, USA), but patients in group A (n = 21) received pre-operative periurethral and transobturator infiltration with epinephrine only, while patients in group B (n = 21) received periurethral infiltration and transobturator with epinephrine plus lidocaine hydrochloride.
Enrollment
Assessed for eligibility (n=78)
Excluded (n=36) ♦ Not meeting inclusion criteria (n=28) ♦ Declined to participate (n=8)
Randomized (n=42)
Allocation Allocated to intervention (n= 21) ♦ Received allocated intervention (n= 21)
Allocated to intervention (n= 21) ♦ Received allocated intervention (n=21)
Follow-Up No patient lost to follow-up
No patient lost to follow-up
Analysis Analysed (n= 21)
13
Analysed (n=21)
Arch Gynecol Obstet
The allocation sequence was concealed from the researchers (CF and AF) who enrolled, assessed, and assigned the participants to the interventions in sequentially numbered, opaque, sealed, and stapled envelopes. The envelopes were opened on the morning of the procedure by the scrub nurse, who prepared the infiltration solution according to the allocated treatment. Patients and the operating surgeon were blinded to the procedure until the end of the study. All patients underwent a pre-operative clinical examination with pelvic organ prolapse quantification (POP-Q) scoring, the Q-tip test, the challenge stress test (CST) with 250 ml bladder filling, and post-void residual urine (PVR) evaluation. In addition, all patients completed the Incontinence-Quality of Life (I-QOL) questionnaire [18], the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [19], and the Patient Global Impression of Severity (PGI-S) questionnaire [20]. Urodynamic tests, including cystometry and the Valsalva leak point pressure evaluation (VLPP, using intravesical pressure, measured in the lithotomy position, with the bladder filled at the normal desired level to void) were also performed. Intrinsic sphincter deficiency was diagnosed if the VLPP was
General Gynecology
Effect of local infiltration analgesia on post‑operative pain following TVT‑O: a double‑blind, placebo‑controlled randomized study Giovanni A. Tommaselli · Costantino Di Carlo · Carmen Formisano · Annamaria Fabozzi · Carmine Nappi
Received: 28 November 2013 / Accepted: 12 February 2014 © Springer-Verlag Berlin Heidelberg 2014
Abstract Purpose To evaluate the effect of a protocol of local anesthesia and epinephrine associated with sedo-analgesia on post-TVT-O pain in comparison with infiltration of saline and epinephrine. Methods Forty-two patients undergoing TVT-O were randomized into two groups to receive periurethral infiltration with epinephrine only (group A, n = 21) or with epinephrine plus 1 % lidocaine hydrochloride (group B, n = 21). Post-operative pain was assessed using a visual analog scale (VAS) from 0 (absence of pain) to 10 (maximum pain possible), 1, 6, 12 and 24 h after the procedure. The total amount of analgesia was recorded and the proportion of women reporting a pain VAS score ≥4, 1 h after the procedure was calculated. ANOVA for repeated measures and Bonferroni correction, the Student’s t test for independent samples, the Mann–Whitney U test, the Fisher exact test, or the χ2 test for parametric was used. Results Pain level was significantly lower in group B 1 (p = 0.01) and 6 h (p = 0.05) after surgery, but not 12 and 24 h after the procedure. No significant difference was observed in the proportion of women requesting analgesia and in the total dosage of analgesics between the two groups. A significant higher proportion of women in group A reported a pain VAS score higher than four 1 h after surgery in comparison with patients in group B.
G. A. Tommaselli (*) · C. Di Carlo · C. Formisano · A. Fabozzi · C. Nappi Department of Neuroscience and Reproductive and Odontostomatologic Sciences, University of Naples “Federico II”, Via S. Pansini, 5, 80131 Naples, Italy e-mail: [email protected]
Conclusions This randomized study seems to indicate that systematic infiltration before TVT-O positioning with local anesthetic may reduce immediate post-operative pain. Keywords Local analgesia · Post-operative pain · Stress urinary incontinence · TVT-O
Introduction The transobturator approach, both inside-out and outsidein, for the positioning of midurethral sling has become widely used for the surgical treatment of female stress urinary incontinence (SUI) [1, 2]. It yields similar objective and subjective cure rates in comparison with retropubic TVT and implies a lower risk of organ and vessel injuries [3, 4]. Nevertheless, this technique has been associated with a higher rate and intensity of post-operative pain [5]. The aim of surgery for SUI in the last years has been to further reduce invasiveness. With this aim, single-incision devices were introduced to avoid the passage through the retropubic space or the obturator foramen and to reduce complications, post-operative pain, and the return to daily activities and to work [6]. Data on the effectiveness of these devices are still limited and controversial [6, 7]. For these reasons, the possibility of reducing post-operative pain using transobturator devices has been further investigated. de Leval and co-workers [8] recently introduced a new inside-out transobturator device with a shortened tape that proved to have the same mid-term effectiveness as the original TVT-O, while reducing post-operative pain [9]. Neuman et al. [10] suggested a modification of the original TVT-O technique with a medial deviation, passing perpendicularly through the medial part of the obturator
13
Arch Gynecol Obstet
membrane and muscles, in an attempt to cause less tissue damage and reduce post-operative pain. This modification has been demonstrated to reduce both the intensity and duration of post-operative pain in comparison to the original technique [11]. Our group recently demonstrated that post-operative pain was significantly reduced using a slight modification of the original TVT-O, with less paraurethral dissection, avoidance of perforating the obturator membrane with the scissors or the guide, and using a more medial trajectory of the trocars [12, 13]. Infiltration of the operative site with local anesthesia is a well-established procedure for post-operative analgesia across procedures [14–17], widely used in urogynecology and easy to perform, but there are no reports on its efficacy on post-operative pain after TVT-O. The aim of this double-blind, placebo-controlled, randomized study was to assess if a standardized protocol of local anesthesia and epinephrine associated with sedoanalgesia is associated with a lower post-operative pain after TVT-O in comparison with infiltration of saline and epinephrine.
Materials and methods This double-blind, placebo-controlled, randomized study was performed in the urogynecological unit of our
Fig. 1 Flow of patient throughout the study
institution. From January 2011 to September 2011, 78 patients affected by stress urinary incontinence (SUI) were evaluated for inclusion in the study. Inclusion criteria were: SUI as diagnosed by clinical evaluation and urodynamics, age >30 years, and previously failed pelvic floor muscle training. Exclusion criteria were: previous surgery for SUI, isolated overactive bladder symptoms, pelvic organ prolapse ≥ POP stage II, presence of neurological disease, sensitivity to local anesthetics, paracetamol or tramadol, and serious contraindications to surgical procedures. The study was approved by the Institutional Review Board of our institution and all patients gave informed consent to participate in the study. As requested by the Consolidated Standards of Reporting Trials (CONSORT), the flow of patients throughout the study is illustrated in Fig. 1. Fifty patients satisfied the inclusion criteria, but eight refused to undergo the randomization process and were thus excluded from the study. The remaining 42 patients were randomized into two groups in a 1:1 ratio using a randomization list generated by a computer. All patients were scheduled to undergo the midurethral sling procedure using the TVT-O device (Ethicon Gynecare, Somerville, NJ, USA), but patients in group A (n = 21) received pre-operative periurethral and transobturator infiltration with epinephrine only, while patients in group B (n = 21) received periurethral infiltration and transobturator with epinephrine plus lidocaine hydrochloride.
Enrollment
Assessed for eligibility (n=78)
Excluded (n=36) ♦ Not meeting inclusion criteria (n=28) ♦ Declined to participate (n=8)
Randomized (n=42)
Allocation Allocated to intervention (n= 21) ♦ Received allocated intervention (n= 21)
Allocated to intervention (n= 21) ♦ Received allocated intervention (n=21)
Follow-Up No patient lost to follow-up
No patient lost to follow-up
Analysis Analysed (n= 21)
13
Analysed (n=21)
Arch Gynecol Obstet
The allocation sequence was concealed from the researchers (CF and AF) who enrolled, assessed, and assigned the participants to the interventions in sequentially numbered, opaque, sealed, and stapled envelopes. The envelopes were opened on the morning of the procedure by the scrub nurse, who prepared the infiltration solution according to the allocated treatment. Patients and the operating surgeon were blinded to the procedure until the end of the study. All patients underwent a pre-operative clinical examination with pelvic organ prolapse quantification (POP-Q) scoring, the Q-tip test, the challenge stress test (CST) with 250 ml bladder filling, and post-void residual urine (PVR) evaluation. In addition, all patients completed the Incontinence-Quality of Life (I-QOL) questionnaire [18], the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [19], and the Patient Global Impression of Severity (PGI-S) questionnaire [20]. Urodynamic tests, including cystometry and the Valsalva leak point pressure evaluation (VLPP, using intravesical pressure, measured in the lithotomy position, with the bladder filled at the normal desired level to void) were also performed. Intrinsic sphincter deficiency was diagnosed if the VLPP was
