Phase 2
N=44
Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization
Leiomyoma
Bottom Line
View on ClinicalTrials.gov: NCT02270255 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS) — 11; 5.1 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Superior hypogastric nerve block (Procedure); 0.75% Ropivacaine (Drug); Subcutaneous injection (Procedure); 1% Xylocaine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS) |
11; 5.1 | — |
| SECONDARY Number of Patients With Serious Adverse Reactions From Superior Hypogastric Nerve Block |
0; 0 | — |
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 controlled analgesic (PCA) pumps for pain control and discharged the next day with heavy pain medications. The goal of this study is to evaluate the effectiveness of a superior hypogastric nerve block (SHGNB) in controlling the pain post-UFE.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02270255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.