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

June 7, 2019 updated by: Birmingham Women's and Children's NHS Foundation Trust

Randomized Double-blind Placebo Controlled Trial to Assess the Role of Intrauterine Cornual Block (ICOB) in Combination With Direct Cervical Block in Outpatient Endometrial Ablation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Outpatient local anaesthesic (LA) hysteroscopic intrauterine therapeutic interventions such as endometrial ablation have gained wider acceptance in the last decade. However, pain experienced during these procedures can be a disincentive and is the commonest reason for the use of escalating levels of analgesia post procedure, which results in prolongation of hospital stay and recovery. Various methods of LA have been studied including intrauterine topical lignocaine or cervical block using topical lignocaine, paracervical block or intracervical block. However, a single site block individually may not be sufficient to control the pain completely due to inability of the one site block to affect the sensitivity of the whole uterus, as the uterine fundus is effectively still unanaesthetised. This may be due to the uterus receiving complex innervations from different nerve routes such as the uterovaginal plexus, the Frankenhauser nerve plexuses, parasympathetic ganglia and the thoracic nerve.

Therefore, it seems logical to use a direct cervical block to block the sensation through uterovaginal plexus and use an additional deep myometrial block adjacent to each cornua to directly block the thoracic nerve supply. To date, only one small observational study has looked at the effect of such a combined block in relieving pain during outpatient hysteroscopic procedures. Therefore, we propose to undertake a double blind randomised controlled trial to address this question by comparing effectiveness of a standard direct cervical block and intrauterine cornual block (ICOB) versus a direct cervical block and a normal saline intrauterine cornual injection (control).

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TG
        • Birmingham Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local anaesthetic
2mls consisting of 1ml of 3% mepivacaine (short / medium acting) and 1ml of 0.5% bupivacaine (long acting)
Procedure: Local Anaesthetic
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)
Other Names:
  • Mepivacaine and bupivacaine
Placebo Comparator: Saline
2mls of Normal Saline solution in a 5ml syringe
Procedure: Local Anaesthetic
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)
Other Names:
  • Mepivacaine and bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue scale evaluating pain
Time Frame: administered immediately after the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue scale evaluating pain
Time Frame: 1 hour after procedure and at discharge from hospital
  1. 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.
  2. To assess the total requirements for rescue analgesia in the first 24-hour post-operative period between the two groups.
1 hour after procedure and at discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birmingham Women's and Children's NHS Foundation Trust

Collaborators

University of Birmingham

Investigators

  • Principal Investigator: Janesh K Gupta, MSc MD FRCOG, Birmingham University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 24, 2013

First Submitted That Met QC Criteria

March 8, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/BWH/NO75

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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