Office hysteroscopy has been one of the widely used diagnostic tools in the contemporary gynecology. Along with direct biopsy, hysteroscopy has even been the gold standard method for diagnosing endometrial pathology 1. One of the main advantages of office hysteroscopy is being an office procedure that does not require general or regional anesthesia in the majority of patients 2. Nevertheless, office hysteroscopy is not a pain-free procedure. Indeed, the major reason for declining such a diagnostic tool by women is pain 3. Several solutions have been proposed to manage such a problem, including intravenous sedation using benzodiazepines 4,5, administration of NSAIDs 1 or tramadol 6, and local anesthetic agents 7. There has been a number of studies regarding the local anesthetic agent used (whether mepivacaine, lignocaine, or bupivacaine) and the route of application (whether topical, intracervical, or paracervical) 7,8. The aim of the current study was to compare the efficacy of intracervical anesthesia with that of combined intracervical and paracervical anesthesia in women undergoing office hysteroscopy at Ain-Shams University Maternity Hospital.
Patients and methods
The current randomized controlled trial was conducted at the Early Cancer Detection Unit (ECDU) in Ain-Shams University Maternity Hospital during the period between June 2011 and December 2011. The study protocol was designed in accordance to the Declaration of Helsinki for the Ethical Principles of Medical Research and a-priori approval was obtained by the Ethical Research Committee at Obstetrics and Gynecology Department, Faculty of Medicine, Ain-Shams University. Participating women had to sign informed consent about the purpose of the study. The study included women referred to the ECDU for office (outpatient) hysteroscopy. Women whose indications necessitate performing the procedure under general anesthesia or those who personally requested for performing the procedure under general anesthesia were not included in the trial. Randomization was performed using a computer-generated randomization system. The allocation labels were kept in serially numbered sealed envelopes. Envelopes were only disclosed just before the procedure. The included women were randomized into one of the three groups: group 1 included women who received no local anesthesia; group 2 included women who received intracervical local anesthesia; and group 3 included women who received both intracervical and paracervical local anesthesia. A bivalve speculum was inserted into the vagina to expose the cervix. Intracervical anesthesia was achieved by injecting 2 ml of the local anesthetic (lignocaine 2%) into the anterior cervical lip at the 12 o’clock position. Paracervical anesthesia was achieved by injecting the local anesthetic (lignocaine 2%) into both lateral vaginal fornices (at the 3 and 9 o’clock positions) at a depth of 10 mm (4 ml on each side). A period of ∼5 min was left between injection of the local anesthetic and starting the procedure. The anterior cervical lip is first grasped with a tenaculum at the 12 o’clock position. A rigid 3.5-mm hysteroscope (Karl Storz, Tuttlingen, Germany) was used with isotonic saline as a distending medium. Pain was assessed during the procedure and 10, 30, and 60 min after the procedure. Pain was objectively assessed using a 10-cm visual analog scale (VAS) (with 0 implying no pain and 10 implying the worst pain).
Sample size justification
Sample size was calculated setting the power at 80% and the type-1 error (α) at 0.05. Data from a previous relevant study 9 showed that the mean pain score during the procedure was 3.2±0.3 in the local anesthetic group and 2.1±0.2 in the combined local and paracervical group. Calculation according to these values produced a minimal sample size of 28 women in each group. Therefore, a total of 84 women were needed to be recruited in the current trial for randomization into three groups.
Statistical analysis was performed using Microsoft Excel version 2010 and SPSS for Windows version 15.0 (SPSS Inc., Chicago, Illinois, USA). Data were described as range, mean, and SD for numeric parametric variables; range, median, and interquartile range (IQR) for numeric nonparametric variables; or number and percentage for categorical variables. Difference between two independent groups was estimated using independent Student’s t-test (for numeric parametric variables), Mann–Whitney’s U-test (for numeric nonparametric variables), or the χ2-test (for categorical variables). Significance level was set at 0.05.
A total of 84 women were analyzed in the trial. Participants’ flow chart is shown in Fig. 1. The mean age of included women was 40.74±8.69 years (range: 26–56 years). Of the included 84 women, 19 (22.6%) were nulliparae, whereas 65 (77.4%) were multiparae. There were no significant differences between women in the three groups with respect to age, parity, indications for office hysteroscopy, or the procedure performed (Table 1). The median duration of the procedure was significantly higher in women of group 2 (the intracervical anesthesia group) and group 3 (the combined intracervical and paracervical anesthesia group) when compared with women of group 1 (the no anesthesia group) [6 min (range: 5–10 min; IQR: 6–7 min), 6 min (range: 2–9 min; IQR: 6–8 min), and 3 min (range: 2–10 min; IQR: 2–4 min), respectively, P<0.001]. This significant difference remained even after excluding patients who underwent septum resection and adhesiolysis from the analysis. The median VAS for pain was significantly lower in women who received cervical anesthesia (groups 2 and 3) when compared with women who received no anesthesia (group 1), during the procedure as well as 10, 30, and 60 min after the procedure. The median VAS for pain was significantly lower in women who received combined intracervical and paracervical anesthesia (group 3) when compared with women who received only intracervical anesthesia (group 2), during the procedure and 10 min after the procedure. However, the difference between the latter two groups regarding the VAS for pain 30 and 60 min after the procedure was not significant (Table 2). Only three (3.6%) patients of the included 84 women were complicated; two (2.4%) had more-than-usual bleeding (one patient in group 1 and one patient in group 2); and one (1.2%) had a vasovagal reaction (in group 1). The difference between the three groups with respect to the incidence of complications was obviously not significant. The proportion of unsatisfied women were significantly higher in group 1 when compared with groups 2 and 3. The proportion of unsatisfied women were higher in group 2 when compared with group 3 but not to a significant level (Fig. 2).
The current study showed that combined intracervical and paracervical local anesthetic (lignocaine 2%) injection was significantly superior to intracervical local anesthetic injection alone in controlling pain during office hysteroscopy. This significant superiority remained for 10 min after the procedure. Pain control was comparable in both approaches 30 and 60 min after the procedure. The patient satisfaction rate was higher with combined anesthesia when compared with intracervical anesthesia, but the difference did not reach a statistical significance. Either approach was significantly superior in controlling pain compared with performing the procedure without anesthesia. The rate of unsatisfied women was significantly high among those who underwent the procedure without anesthesia.
The results of the current study agree with those of a very similar randomized trial conducted by Al-Sunaidi and Tulandi 9 on 85 women planned to undergo office hysteroscopy at McGill University Health Center, Quebec, Canada. This study showed significantly less pain during the procedure as well as 10 and 30 min after the procedure. The difference between both approaches with respect to the pain score 60 min after the procedure was insignificant. This ‘more-prolonged’ superiority of the combined paracervical and intracervical anesthesia over the intracervical anesthesia shown by the latter study may be explained by the different local anesthetic used (bupivacaine in the latter study). In addition, this study randomized recruited women into one of those two groups only; there was no third group in which patients underwent the office hysteroscopy procedure without local anesthesia. Adding this third group was actually representing the daily practice in the ECDU at Ain-Shams University Maternity Hospital. Injection of a local anesthetic agent before office hysteroscopy procedure was not a routine practice in the past and has only been just a part of the medical research. Few authors stated that most women could tolerate office hysteroscopy without anesthesia 10,11. Recent literature was, however, remarkably different. In a large study on 1144 women, 34.8% of patients experienced severe pain 12. Most of the authors of the recently published trials and reviews concluded that office hysteroscopy should be performed under some sort of local anesthesia 3,7,8.
Early studies showed no significant efficacy of local anesthesia in pain control in women undergoing office hysteroscopy. In a study conducted by Broadbent et al.12 in 1992, local intracervical anesthesia was as good as placebo in outpatient hysteroscopy. In a second study conducted in 1993, Downes and Al-Azzawi showed that intracervical anesthesia was effective in pain control during hysteroscopy; 40% of patients, however, still experienced moderate pain 13. However, the results of subsequent studies were quite different. In a well-conducted systematic review and meta-analysis of 20 trials on 2851 women 8, Cooper et al.8 concluded that intracervical and paracervical local anesthesia significantly reduced the pain in women undergoing hysteroscopy as outpatients and that transcervical and topical application did not reduce the pain. Furthermore, metaregression analysis showed that paracervical injection was superior to intracervical local injection. This remarkable change in the published data with respect to the efficacy of local anesthesia over the past two decades (from no efficacy to superior efficacy) is probably explained by a number of reasons. First, most of the early published trials investigated the intracervical injection only. The uterus and cervix are known to be innervated through the Frankenhäuser plexus of parasympathetic nerves; the sympathetic nerves from the ovarian plexus innervate the uterine fundus. Intracervical injection of local anesthesia would not block fundal innervation, and therefore may not be quite effective in pain control 9. Faulty technique was a second possible reason. In a randomized trial conducted by Lau et al.10, the authors found that paracervical local injection of lignocaine 2% was effective in reducing the pain only at the time of introduction of the hysteroscope but not at the subsequent steps of the procedure. They even found that there were high rates of hypotension and bradycardias following this paracervical block. Inadvertent intravascular injection was probably the cause for such low efficacy and high risk for local anesthetic toxicity.
When compared with intracervical injection, combined intracervical and paracervical anesthesia was associated with less pain perception during the procedure and 10 min after the procedure in women undergoing office hysteroscopy; the difference between the two approaches was not significant thereafter.
Conflicts of interest
There are no conflicts of interest.
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Keywords:© 2014 Lippincott Williams & Wilkins, Inc.
intracervical anesthesia; office hysteroscopy; outpatient hysteroscopy; pain during hysteroscopy; paracervical anesthesia