Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02270255
• Date of registration: 16/10/2014
• Prospective Registration: Yes
• Primary sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Public title: Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization
• Scientific title: Prospective Blinded Study Looking at PO/IV Analgesia Alone Versus PO/IV Analgesia With Superior Hypogastric Nerve Block for Uterine Artery Embolization Pain Management
• Date of first enrolment: April 2015
• Target sample size: 44
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02270255
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Louis-Martin NJ Boucher, MD/PhD
• Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

1. All women with symptomatic fibroids or adenomyosis that have requested and been
approved for uterine artery embolization

2. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

1. Patients in whom the vascular anatomy prevents access to the superior hypogastric
nerve plexus safely

2. Patients who have known allergy to the anesthetic agent

3. Patients with signs of skin infection at the entry site of the needle used to place
the nerve block

4. Patients with signs of infection such as fever

5. Patients with history of inflammatory bowel disease of with signs of colitis

6. Patients with uncorrectable abnormal coagulation status (INR >1.5 and plt < 50000
without use of anticoagulation agents)

7. Patients with preexisting conditions, which, in the opinion of the investigator,
interfere with the conduct of the study.

8. 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.

9. Patients with a mental state that may preclude completion of the study procedure or is
unable to provide informed consent



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Leiomyoma

Intervention(s)

Procedure: Superior hypogastric nerve block

Drug: 1% Xylocaine

Drug: 0.75% Ropivacaine

Procedure: Subcutaneous injection

Primary Outcome(s)

mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS) [Time Frame: 6 hrs (from time of end of UFE to time of discharge from recovery room)]

Secondary Outcome(s)

Number of Patients With Serious Adverse Reactions From Superior Hypogastric Nerve Block [Time Frame: 10 days]

Secondary ID(s)

4242

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02270255