Intrauterine fundal anaesthesia during endometrial ablation in the office: A randomised double-blind, non-inferiority trial.

OBJECTIVE: To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation. STUDY DESIGN: A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods. RESULTS: Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women). CONCLUSION: This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.

Local anaesthesia during endometrial ablation: a systematic review.

BACKGROUND: Endometrial ablation has been widely implemented in the outpatient setting. Many different protocols of local anaesthesia during endometrial ablation are used and described. However, prospective studies to assess and evaluate these protocols appear to be scarce. OBJECTIVES: To evaluate systematically the different local anaesthesia techniques in relation to pain perception during endometrial ablation. SEARCH STRATEGY: Medline and Embase were systematically searched and reference lists of selected articles were checked for missed publications. SELECTION CRITERIA: All types of studies reporting the performance of endometrial ablation under local anaesthesia in ten or more women were included. DATA COLLECTION AND ANALYSIS: Data about the procedure, the protocol of local anaesthesia, the acceptability and side-effects were extracted. MAIN RESULTS: Twenty-five studies, involving 2013 women, were included. Applied anaesthesia techniques included intracervical, paracervical and intrauterine anaesthesia or a combination of these techniques. Women who received a combination of either intra- or paracervical anaesthesia and intrauterine injections reported significantly lower pain scores than those who received no local anaesthesia or intra- or paracervical anaesthesia alone (P = 0.000), but the quality of evidence is low. The acceptability of endometrial ablation under local anaesthesia was high (77-94%). CONCLUSION: Endometrial ablation under local anaesthesia is a safe, feasible and acceptable procedure. The combination of either intra- or paracervical anaesthesia with intrauterine injections seems to be promising, but has to be investigated more thoroughly. TWEETABLE ABSTRACT: Systematic review of local anaesthesia techniques during endometrial ablation.