British Journal of Obstetrics and Gynaecology September 1992, Vol. 99, pp. 777-780

SHORT COMMUNICATIONS

Randomized placebo controlled trial to assess the role of intracervical lignocaine in outpatient hy steroscopy J . A. M . B R O A D B E N T Clinical Research Fellow N. C . W. HILL LecturerlHonorary Senior Registrar B. G. MOLNAR Wellcome Research Fellow

K . J. ROLFE Clinical Research Sister A . L. MAGOS Consultant Obstetrician & Gynaecologist Minimally Invasive Therapy Unit University Department of Obstetrics & Gynaecology The Royal Free Hospital Pond Street, Hampstead, London NW3 2QG, UK Outpatient hysteroscopy is now regarded as the investigation of choice for abnormal uterine bleeding as there is no longer any doubt that hysteroscopy is more effective than conventional curettage at identifying intrauterine pathology (Gimpelson, 1984; Goldrath & Sherman, 1985; Gimpelson & Rappold, 1988; Loffer 1989) as it allows direct inspection of the uterine cavity, directed biopsy and appropriate therapeutic management. Another important advantage of hysteroscopy is that it can be performed without general anaesthesia and, in our experience, only 28.5% of patients required local anaesthesia; this was significantly associated with the need to dilate the cervix (Hill et al. 1992). In order to assess the role and efficacy of local anaesthesia before hysteroscopy, a randomized placebo controlled double blind trial was performed comparing intracervical lignocaine with saline.

gauge needle through which 10 ml of either lignocaine 1% with 1:200 000 adrenaline or normal saline was injected into the cervix at 1, 5, 7, and 11 o’clock. Hysteroscopy was performed at least 5 min later using a 4 mm HAMOU 1 microcolpohysteroscope with a 30 degree fore-oblique lens and a 5.5 mm diagnostic sheath. The uterine cavity was distended with carbon dioxide via a HAMOU microhysteroflator; illumination was provided by a high intensity cold light source (250 W) via a fibre optic lead (all equipment manufactured by Karl Storz GmbH, Germany). The images were viewed on a high resolution colour monitor using a chip camera. Endometrial biopsies were performed where indicated. Assessments of both lower abdominal and shoulder tip pain were made using visual analogue scales before, during, immediately after and 30 min after hysteroscopy. The women were also questioned as to whether the hysteroscopy or the intracervical injection was the more painful. The results were statistically analysed using the Mann-Whitney U-test and test.

x2

Results The median age of the women was 43 (range 25-59) years; 2% were post-menopausal; 16%had never been pregnant and 3 1% had been sterilized previously. There was no significant difference in any of these characteristics between the lignocaine and saline groups. There was also no difference in the women’s mood or anxiety, and occurrence of stomach or shoulder pain prior to hysteroscopy between the two groups. The indications for hysteroscopy are shown in Fig. 1. Hysteroscopy was unsuccessful in three women: two (one from

Subjects and methods One hundred consecutive women undergoing outpatient hysteroscopy for abnormal uterine bleeding consented to be included in the study; prior support for the study was obtained from the local medical ethics committee. Each patient was randomly allocated to receive either lignocaine 1% or normal saline intracervically. Randomization was performed using a predetermined randomization code in a double blind fashion. Before hysteroscopy, assessments of patient mood, anxiety, presence and severity of lower abdominal and shoulder tip pain were made using a 10 cm visual analogue scale. The intracervical injection was performed using a 22 French Correspondence: J. A. Mark Broadbent.

..................... ................

3

IMB 8

PMB 2

1Z

Fig. 1. Indications for hysteroscopy. IMB = intermenstrual bleeding; PMB = postmenopausal bleeding; PCB = postcoital bleeding.

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Table 1. Effect of intracervical lignocaine (lig) or saline (sal) on abdominal and shoulder, tip pain before, during and after hysteroscopy.

Before

During

After

30 min after

Degree of pain*

Lig

S a1

Lig

Sal

Lig

Sal

Lig

Sal

Abdominal pain None

37

8 20 14 7

4 15 17 12

14 27 7 1

24 16 6 3

21 21 5 0

49

48

Mild

5

Moderate Severe Total

6 2

36 10 6 1

50

50

49

48

49

11 26 I0 1 48

48 1 0

46 3 1 0

42 3 3 1

43 2 3 0

37 5 4 3

34 8 3 3

42 3 4 0

36 6 6 0

50

50

49

48

49

48

49

48

Shoulder tip pain None Mild Moderate Severe Total

1

Results are numbers of women. *Assessed on a 10 cm visual analogue scale. each group) found the procedure too painful, and one patient fainted after the intracervical injection of saline. These women were excluded from further analysis. During hysteroscopy, 47 women experienced no, or mild, abdominal pain, 3 1 moderate and 19 severe abdominal pain, but only 12 had shoulder tip pain (Table 1). There was no significant difference between the incidence of stomach or shoulder tip pain between the women treated with lignocaine or saline. Immediately after hysteroscopy, 53 women had mild pain, but only two severe pain; 26 women had residual shoulder tip pain. There was no difference in these rates between the two groups. Thirty minutes later, 51 women still had some degree of stomach pain and 19 shoulder tip pain, but again these rates were no different between the lignocaine and saline groups. In total, 43% of women found the intracervical injection the most painful part of the procedure and a further 22% found the injection at least as painful as the hysteroscopy.

Discussion Approximately one-third of all gynaecological consultations are as a result of abnormal uterine bleeding (Coulter et al. 1988) and this proportion rises to almost three-quarters for pen- or post-menopausal patients (Mencaglia et al. 1987). Traditionally, over half these patients would have been investigated by dilatation and curettage (Coulter et al. 1991), accounting for 26.7% of all gynaecological operative procedures (Mackenzie & Bibby 1978). Out-patient hysteroscopy is now the preferred method of investigation for these patients and more and more hysteroscopies are now being performed without general anaesthesia. The use of intracervical lignocaine has been shown to be effective as a local anaesthetic when performing procedures on the uterus, such as dilatation and curettage and suction termination of pregnancy. It is surprising, then, to find the results of this study show that there was no statistically significant difference between the two groups with regard to discomfort associated with hysteroscopy. Those women receiving intracervical lignocaine experienced no less discomfort than those receiving

saline. This may be a reflection of the type of analgesia used. The sensory nerve supply of the uterus is derived from Frankenhauer’s plexus (parasympathetic S2-4) which supplies the cervix and the lower portion of the uterus; however, the fundal region derives its sensory innervation from the ovarian nerve plexus. Therefore, intracervical lignocaine will be effective in reducing the sensitivity of the cervix but will be ineffective at blocking fundal innervation of the uterus. It is possible that paracervical block, either alone or in conjunction with intracervical block, will be a more effective anaesthetic for hysteroscopy, although this was found not to be the case with laser ablation of the cervical transformation zone (Johnson et al. 1989). Another aspect highlighted by this study is the fact that the majority of patients (65%) found the intracervical injection either more, or as painful, as the hysteroscopy. This in itself raises the question of ‘who are we treating?’, the patient or the physician. It soon became apparent to those conducting the study that the administration of the intracervical injection, whether lignocaine or saline, was itself a painful procedure. In fact, with one patient the procedure had to be abandoned as she fainted following injection of saline. It may well be that administration of anaesthetic solution through a narrower bore needle, such as with dental syringe, may be better tolerated but this needs to be assessed. It would, therefore, appear that the routine administration of intracervical lignocaine is not only ineffective as pain relief during hysteroscopy but can also be counter-productive. We would advocate the use of this form of local anaesthesia in cases where cervical dilatation is required and not as a routine.

References Coulter A,, McPherson K. & Vessey M. (1988) Do British women undergo too many or too few hysterectomies? Soc Sci Med 9, 987-994.

Coulter A,, Bradlow J., Agass M., Martin-Bates C. & Tulloch A. (1991) Outcomes of referrals to gynaecologyoutpatient clinics for menstrual problems: an audit of general practice records. BY J Ohstet Gynaecol98, 789-796.

SHORT COMMUNICATIONS

Gimpelson R. J. (1984) Panoramic hysteroscopy with directed biopsies vs dilatation and curettage for accurate diagnosis. J Reprod Med 29,s-12.

Gimpelson R. J. & Rappold H. 0. (1988) A comparative study between panoramic hysteroscopy with directed biopsies and dilatation and curettage. Am J Obstet Gynecol 158,489492. Goldrath M. H. & Sherman A. I. (1985) Office hysteroscopy and suction curettage: can we eliminate the hospital diagnostic dilation and curettage. Am J Ohstet Gynecol152,220-229. Hill N . C. W., Broadbent J. A. M., Magos A. L., Baumann R. & Lockwood G. M. (1992) Local anaesthesia and cervical dilatation for out-patientdiagnostic hysteroscopy.J Ohster Gynuecoll2,33-37. Johnson N., Crompton A. C. & Ramsden S. V. B. (1989) The efficacy of paracervical injections of lignocaine before laser ablation of the

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cervical transformation zone. A randomised placebo-controlled double-blind clinical trial. Br J Ohstet Gynaecol96, 1410-1412. Loffer F. D. (1989) Hysteroscopywith selective endometrial sampling compared with D&C for abnormal uterine bleeding: the value of a negative hysteroscopic view. Obstet Gynecol73, 16-20. MacKenzie I. Z. & Bibby J. G. (1978) Clinical assessment of dilatation and curettage in 1029 women. Lancet ii, 566-568. Mencaglia L., Perino A. & Hamou J. E. (1987) Hysteroscopy in perimenopausal and postmenopausal women with abnormal uterine bleeding. J Reprod Med 32,577-582. Received 12 May 1992 Accepted 20 May 1992

British Journal of Obstetrics and Gynaecology September 1992, Vol. 99, pp. 779-780

Histological sampling of the endometrium-A formal curettage and the Pipelle sampler D I A N A J. F O T H E R G I L L

comparison between

Consultant Pathologist

and examined in batches on a separate occasion to ensure ‘blind’ assessment. All the samples were examined by one histopathologist ( A S H . ) . The amount of tissue obtained by each method was not assessed quantitatively. Samples were obtained with Pipelles from 171 women and by curettage in 138 women. In two of the 171, the Pipelle provided some tissue but was insufficient to allow a diagnosis.

The Jessop Hospital for Women, Leavygreave Road, Sheffield S3 7RE, UK

Results

Senior Registrar VALERIE A. BROWN

Consultant Obstetrician and Gynaecologist A. S H I R L E Y H I L L

Outpatient endometrial sampling using a Pipelle sampler (Cornier 1984) has been shown to be an acceptable technique, comparing favourably with the Vabra aspirator (Kaunitz et al. 1988; Eddowes et al. 1990). These studies have compared alternative out-patient methods but they have not assessed the accuracy of the diagnosis obtained by the sampler compared with traditional dilatation and curettage (D & C), which was the objective of our study.

Subjects and methods One hundred eighty-seven patients (age range 35-84 years) who had been admitted for dilatation and curettage under general anaesthesia, and who had not previously had outpatient endometrial sampling, were included in the study. They were prepared in the usual manner for D & C, but immediately before the procedure, a Pipelle sampler (Prodimed, Neuillyen-Thelle, France) was used. The D & C was then performed in the normal way. The Pipelle samples were not submitted with the curettings but were labelled with a hospital number only Correspondence: Dr. Diana Fothergill, Court Lodge, 50a Trap Lane, Sheffield S 11 7RD.

In 138 cases, the reports on both sampling procedures were identical, except that in 12 of them curettage identified benign polyps which the Pipelle sampler would not have been expected to detect. The four cases of carcinoma were detected by both methods. In a further 26 cases, one of the procedures yielded no tissue and the other yielded material reported as blood, mucus, or atrophic or endocervical tissue. Thus, in 164 out of 187 women, the two techniques were regarded as providing the same results. Table 1 compares the histological findings in the 23 discrepant cases. In 11 cases, simple hyperplasia or atypia was reported in the Pipelle sample but either there were no curettings or they were normal. We think that the foci of abnormality were small and preferentially removed by the first sampling procedure. They may, therefore, have been detected by curettage if that had been the first procedure. No cases of atypia or carcinoma were missed by the Pipelle. In six women, the Pipelle samples showed normal proliferative endometrium, but foci of hyperplasia were seen in the curettings. Three penmenopausal women with irregular bleeding had fragments of proliferative endometrium on curettage, but the Pipelle sample was inadequate for diagnosis in one and no tissue was obtained in the other two. The discrepancy in the histology was inconsequential in the management of these nine

Randomized placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy.

British Journal of Obstetrics and Gynaecology September 1992, Vol. 99, pp. 777-780 SHORT COMMUNICATIONS Randomized placebo controlled trial to asses...
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