Endometrial Diseases Clinical Trial
— ICOBOfficial title:
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
Verified date | May 2015 |
Source | Birmingham Women's and Children's NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birmingham Women's Hospital | Birmingham |
Lead Sponsor | Collaborator |
---|---|
Birmingham Women's and Children's NHS Foundation Trust | University of Birmingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Visual Analogue scale evaluating pain | 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. 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 |
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