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

NCT02270255 | Completed Phase 2 Results

• 1 other identifier: 4242
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Leiomyoma

Keywords

embolization; analgesia

Outcome Measures

Primary Outcomes (1)

• mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS)

  mg equivalent morphine used until discharge from recovery room to maintain pain level below 4/10 (visual analog scale 0/10=no pain to 10/10=worse pain the patient could imagine)

  6 hrs (from time of end of UFE to time of discharge from recovery room)

Secondary Outcomes (1)

• Number of Patients With Serious Adverse Reactions From Superior Hypogastric Nerve Block

  10 days

Study Arms (2)

Control group

SHAM COMPARATOR

Sham procedure. Subcutaneous injection of 5cc of 1% Xylocaine in the periumbilical region.

Procedure: Subcutaneous injection; Drug: 1% Xylocaine

Sup Hypogastric Nerve block group

EXPERIMENTAL

Superior hypogastric nerve block performed during UFE. 20cc of 0.75% Ropivacaine injected at the superior hypogastric nerve plexus.

Procedure: Superior hypogastric nerve block; Drug: 0.75% Ropivacaine

Interventions

Superior hypogastric nerve block PROCEDURE

21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.

Sup Hypogastric Nerve block group

0.75% Ropivacaine DRUG

20 ml of 0.75% Ropivacaine

Also known as: Naropin

Sup Hypogastric Nerve block group

Subcutaneous injection PROCEDURE

Injection into subcutaneous tissues in periumbilical region

Control group

1% Xylocaine DRUG

5ml of 1% Xylocaine

Also known as: Lidocaine

Control group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre - Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (2)

• Rasuli P, Jolly EE, Hammond I, French GJ, Preston R, Goulet S, Hamilton L, Tabib M. Superior hypogastric nerve block for pain control in outpatient uterine artery embolization. J Vasc Interv Radiol. 2004 Dec;15(12):1423-9. doi: 10.1097/01.RVI.0000137406.09852.A4.

  PMID: 15590800 BACKGROUND

• Yoon J, Valenti D, Muchantef K, Cabrera T, Toonsi F, Torres C, Bessissow A, Bandegi P, Boucher LM. Superior Hypogastric Nerve Block as Post-Uterine Artery Embolization Analgesia: A Randomized and Double-Blind Clinical Trial. Radiology. 2018 Oct;289(1):248-254. doi: 10.1148/radiol.2018172714. Epub 2018 Jul 10.

  PMID: 29989515 DERIVED

MeSH Terms

Conditions

Leiomyoma; Agnosia

Interventions

Ropivacaine; Injections, Subcutaneous; Lidocaine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Acetanilides

Limitations and Caveats

Small number of patients. Single centre study. Occasional use of different narcotics needing morphine equivalent calculations. SHAM procedure did not place a needle as deep as in the study group.

Results Point of Contact

• Title: Louis-Martin boucher
• Organization: McGill University Health Centre

lmboucher@yahoo.com

5149341934

Study Officials

• Louis-Martin NJ Boucher, MD/PhD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 21, 2014
• Study Start: April 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 14, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)