Role of Intrauterine COrnual Block (ICOB) in combination with direct cervical block in outpatient endometrial ablatio

Not Applicable

Completed

• Conditions: Outpatient endometrial ablation; Surgery

• Registration Number: ISRCTN10687405
• Lead Sponsor: Birmingham Women's Hospital (UK)

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26546298 (added 27/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-07
• Study Completion: 2014-07-31
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Women between the ages of 18 - 50 years presenting to the gynaecology outpatient clinic scheduled for an outpatient hysteroscopic intrauterine therapeutic intervention such as endometrial ablation

Exclusion Criteria

1. Women with contraindications to hysteroscopic procedures such as atypical endometrial hyperplasia or endometrial cancer, undiagnosed abnormal vaginal bleeding, current lower pelvic infection or uterine abnormalities
2. Women who are allergic to local anaesthesia
3. Not technically possible to perform a hysteroscopy e.g. women with distorted uterine cavity due to large fibroids
4. Women considered vulnerable (e.g. current mental illness, emotionally labile, or learning difficulties)
5. Women who decline to be randomised and request the additional anaesthetic or decline it will form a separate group to be studied and will be administered the VAS similar to the trial group. This group will be analysed separately to determine whether they are significantly different to those patients who consent to being part of the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) evaluating pain administered before, during and immediately after to determine the effectiveness of intrauterine cornual block by evaluating pain directly attributable to outpatient hysteroscopic endometrial ablation assessed by using an ungraduated 10 cm VAS administered immediately after the procedure prior to patient going to the recovery unit.

Secondary Outcome Measures

Name	Time	Method
<br> 1. VAS evaluating pain, 1 hour after procedure and at discharge from hospital to determine the effectiveness of intrauterine cornual block by evaluating pain using VAS at 1 hour after the procedure and prior to discharge from the hospital<br> 2. To assess the total requirements for rescue analgesia in the first 24-hour post-operative period between the two groups<br>