Short-term recovery after NovaSure® endometrial ablation: a prospective cohort study.

Background: Endometrial ablation is a frequently performed treatment for heavy menstrual bleeding, but detailed information about recovery to help inform patients is lacking. Objective: To gain more insight into the short-term recovery after NovaSure® endometrial ablation, with the goal of improving preprocedural counselling. Materials and Methods: A total of 61 women who underwent endometrial ablation between March 2019 and November 2021 in a teaching hospital in the Netherlands were included in this prospective cohort study. Main outcome measures: Short-term recovery was investigated through questionnaires in the first week after the procedure. The primary outcome was the Recovery Index (RI-10). Secondary outcomes included health-related quality of life (EQ-5D-5L), pain intensity, use of analgesics, nausea, vaginal discharge, capability of performing activities (domestic chores, sports, work), self-rated health (EQ-VAS) and the feeling of full recovery. Results: A total of 33 women underwent the procedure under local anaesthesia and 28 women under procedural sedation. The RI-10 increased in the first week; median scores on day one, two and seven were 34 (IQR 28.5-41.5), 38.5 (IQR 31-47), and 42 (IQR 37.5-48), respectively. The median time for full recovery was five days. However, 23% of all women were not fully recovered within seven days. Women needed a median time of two days for returning to their work and 5.5 days for sporting activities. There were no differences in recovery between both anaesthesia techniques. Conclusions: Women undergoing endometrial ablation can be informed that most will fully recover within the first week of the procedure and that there is no difference in expected recovery time according to whether the procedure is undertaken with local anaesthesia or conscious sedation. What is New?: The short-term recovery after endometrial ablation has been mapped in this trial. This information can be used in counselling women with heavy menstrual bleeding.

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.

The effect of music in gynaecological office procedures on pain, anxiety and satisfaction: a randomized controlled trial.

BACKGROUND: Pain can interfere with office procedures in gynaecology. The aim of this study is to measure the positive effect of music in gynaecological office procedures. METHODS: A randomized controlled trial was performed between October 2014 and January 2016. Women scheduled for an office hysteroscopy or colposcopy were eligible for randomization in the music group or control group. Stratification for hysteroscopy and colposcopy took place. The primary outcome is patients' level of pain during the procedure measured by the visual analogue scale (VAS). Secondary outcomes include patients' level of pain after the procedure, anxiety and satisfaction of patient and doctor. RESULTS: No positive effect of music on patients' perception of pain during the procedure was measured, neither for the hysteroscopy group (57 mm vs. 52 mm) nor for the colposcopy group (32 mm vs. 32 mm). Secondary outcomes were also similar for both groups. CONCLUSIONS: This study showed no positive effect of music on patients' level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. We believe a multimodal approach has to be used to decrease patient distress in terms of pain and anxiety, with or without music. TRIAL REGISTRATION: Dutch Trial Register, NTR4924.