Status:
COMPLETED
Role of Intrauterine Cornual Block in Combination With Direct Cervical Block in Outpatient Endometrial Ablation
Lead Sponsor:
Birmingham Women's and Children's NHS Foundation Trust
Collaborating Sponsors:
University of Birmingham
Conditions:
Endometrial Diseases
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
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...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01808898
Start Date
February 1 2013
End Date
February 1 2015
Last Update
June 10 2019
Active Locations (1)
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1
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG