Status:
COMPLETED
Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Leiomyoma
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However the procedure is often very painful and, in many centres, patients are admitted overnight with patient cont...
Detailed Description
This is a double blinded study in which the patients and the primary operators of the UFE as well as the post-procedural caregivers are blinded to whether the patients have received a sham procedure (...
Eligibility Criteria
Inclusion
- All women with symptomatic fibroids or adenomyosis that have requested and been approved for uterine artery embolization
- Ability to comply with the requirements of the study procedures
Exclusion
- Patients in whom the vascular anatomy prevents access to the superior hypogastric nerve plexus safely
- Patients who have known allergy to the anesthetic agent
- Patients with signs of skin infection at the entry site of the needle used to place the nerve block
- Patients with signs of infection such as fever
- Patients with history of inflammatory bowel disease of with signs of colitis
- Patients with uncorrectable abnormal coagulation status (INR \>1.5 and plt \< 50000 without use of anticoagulation agents)
- Patients with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
- Patients who are uncooperative, cannot follow instructions, or who are unlikely to comply with follow-up appointments or fill-out the post-procedural pain questionnaires.
- Patients with a mental state that may preclude completion of the study procedure or is unable to provide informed consent
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02270255
Start Date
April 1 2015
End Date
November 1 2017
Last Update
August 14 2019
Active Locations (1)
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1
McGill University Health Centre - Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1