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

NCT01808898 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2019-06-10

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • University of Birmingham

    collaborator OTHER

  • Birmingham Women's and Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Janesh K Gupta, MSc MD FRCOG · Birmingham University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01808898 on ClinicalTrials.gov