Role of Intrauterine Cornual Block in Combination With Direct Cervical Block in Outpatient Endometrial Ablation

NCT01808898 | Completed Phase 4

• 1 other identifier: 12/BWH/NO75
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The usual intervention to control the pain during an outpatient endometrial ablation has been to use local anaesthesia (LA) injection just in the neck of the womb (cervix). However, this alone may not be sufficient to control the pain completely. Therefore, we want to find out whether an injection of LA given deep into the muscle of the womb (myometrium), in addition to that in the cervix, has a better effect on controlling the pain during the procedure. All women attending gynaecology outpatient clinics, who have consented for an outpatient hysteroscopic procedure, will be invited to take part in the study. The study will be carried out in the outpatient hysteroscopy clinic at Birmingham Women's Hospital. As part of standard pain control method during an outpatient endometrial ablation, all women will receive an injection of LA in the cervix of the uterus to 'freeze it'. During hysteroscopy a randomly selected treatment group will receive an injection into deep muscle containing only normal saline (control group) whereas the experiment group will receive fast / long acting local anaesthesia (cornual block). Women will be asked to rate the degree of pain by placing a mark on an ungraduated 10 cm horizontal line. These scales will be given before the procedure, during LA injection, immediately after, one hour and at the time of discharge from hospital. The results will help future patients undergoing a similar procedure to have much better pain relief and allow many more to have the procedure without the side effects of a general anaesthetic and its risks. In addition to having less pain, it may reduce the number of painkillers needed as well as any stay in hospital. In future this may also allow a greater variety of procedures to be done in an outpatient setting.

Conditions

Endometrial Diseases

Keywords

Ablation; Outpatient

Outcome Measures

Primary Outcomes (1)

• Visual Analogue scale evaluating pain

  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 visual analogue scale (VAS) administered immediately after the procedure prior to shifting patient to the recovery unit.

  administered immediately after the procedure

Secondary Outcomes (1)

• Visual Analogue scale evaluating pain

  1 hour after procedure and at discharge from hospital

Study Arms (2)

Local anaesthetic

EXPERIMENTAL

2mls consisting of 1ml of 3% mepivacaine (short / medium acting) and 1ml of 0.5% bupivacaine (long acting)

Procedure: Local Anaesthetic

Saline

PLACEBO COMPARATOR

2mls of Normal Saline solution in a 5ml syringe

Procedure: Local Anaesthetic

Interventions

Local Anaesthetic PROCEDURE

On the day of the procedure and before the patients are treated, a designated clinician will draw up the local anaesthetic (2mls consisting of 1ml of 3% mepivacaine (short / medium acting) and 1ml of 0.5% bupivacaine (long acting)

Also known as: Mepivacaine and bupivacaine

Local anaesthetic; Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All 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.

You may not qualify if:

• 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
• Women who are allergic to local anaesthesia
• Not technically possible to perform a hysteroscopy e.g. women with distorted uterine cavity due to large fibroids
• Women considered vulnerable (e.g. current mental illness, emotionally labile, or learning difficulties)
• 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.

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead
• University of Birmingham: collaborator

Study Sites (1)

Birmingham Women's Hospital

Birmingham, B15 2TG, United Kingdom

Location

Related Publications (1)

• Kumar V, Tryposkiadis K, Gupta JK. Hysteroscopic local anesthetic intrauterine cornual block in office endometrial ablation: a randomized controlled trial. Fertil Steril. 2016 Feb;105(2):474-80.e1. doi: 10.1016/j.fertnstert.2015.10.019. Epub 2015 Nov 4.

  PMID: 26546298 DERIVED

MeSH Terms

Conditions

Uterine Diseases

Interventions

Anesthesia, Local; Mepivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Janesh K Gupta, MSc MD FRCOG

  Birmingham University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2013
• First Posted: March 11, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 10, 2019

Record last verified: 2015-05

Locations

GB (1)