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Effect of Addition of Steroids on Duration of Analgesia

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04126824
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
62.9
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Investigators will enroll a total of 28 women undergoing the UAE procedure with 14 subjects in each study arm. This investigation is a single blind randomized control trial investigating the post-procedural analgesic effect of adding a corticosteroid (Triamcinolone) as an adjuvant to a SHNB that contains bupivacaine for patients undergoing UAE, compared to patients undergoing nerve block for pain control following UAE with local anesthetic only. Before and after the procedure, patients will be asked to complete online surveys in order to record their pain score (measured on the Visual Analog Pain Scale), opioid and other pain medication use, and other symptoms, such as nausea.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Controlled Clinical Trial: Superior Hypogastric Nerve Block for Pain Control After Uterine Artery Embolization: Effect of Addition of Steroids on Duration of Analgesia
Actual Study Start Date :
Nov 5, 2019
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupivacaine

During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.

Drug: Bupivacaine
0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
Other Names:
  • Marcaine, Exparel

    • Other: Iohexol contrast
    The appropriate amount of contrast to enable visualization of the nerve block under fluoroscopy given as a Superior Hypogastric Nerve Block (SHNB) will be administered.
    Other Names:
  • Omnipaque

    		•
    Experimental: Bupivacaine and Triamcinolone

    During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine plus triamcinolone mixed with contrast to enable visualization of the nerve block under fluoroscopy.

    Drug: Triamcinolone
    40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)
    Other Names:
  • Kenalog

    • Drug: Bupivacaine
    0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
    Other Names:
  • Marcaine, Exparel

    • Other: Iohexol contrast
    The appropriate amount of contrast to enable visualization of the nerve block under fluoroscopy given as a Superior Hypogastric Nerve Block (SHNB) will be administered.
    Other Names:
  • Omnipaque

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Pain Intensity Measure (mm) [Baseline, 240 hours]

      The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • females

    • aged between 30 and 60 years

    • diagnosed with symptomatic uterine fibroids and/or adenomyosis and scheduled to undergo UAE procedure

    Exclusion Criteria:

    • Contraindications to UAE

    • SHNB is deemed unsafe for the patient

    • Allergies to local anesthetic or steroid agent

    • History of inflammatory bowel disease or ulcerative colitis

    • Uncorrectable abnormal coagulation profile

    • Diabetes mellitus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • University of California, Los Angeles

    Investigators

    • Principal Investigator: Jessica K Stewart, MD, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jessica K. Stewart, MD, Principal Investigator, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT04126824
    Other Study ID Numbers:
    • 21-001880
    First Posted:
    Oct 15, 2019
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Jessica K. Stewart, MD, Principal Investigator, University of California, Los Angeles
    Uterine Artery Embolization
    Additional relevant MeSH terms:
    Leiomyoma
    Adenomyosis
    Triamcinolone
    Bupivacaine

    Study Results

    No Results Posted as of Mar 28, 2022