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Effect of Addition of Steroids on Duration of Analgesia

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ClinicalTrials.gov Identifier: NCT04126824
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Jessica K. Stewart, MD, University of California, Los Angeles

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
Uterine Fibroids Adenomyosis Drug: Triamcinolone Drug: Bupivacaine Other: Iohexol contrast 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 5, 2019
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025


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 Name: 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 Name: 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 Name: Kenalog

Drug: Bupivacaine
0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
Other Name: 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 Name: Omnipaque




Primary Outcome Measures :
  1. Change in Pain Intensity Measure (mm) [ Time Frame: 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".



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126824


Contacts
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Contact: Tammy L Floore 310-794-9202 tfloore@mednet.ucla.edu
Contact: Saima Chaabane 310-794-8995 schaabane@mednet.ucla.edu

Locations
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United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Hannah Mignosa    984-215-4963    hannah_mignosa@med.unc.edu   
Contact: Markeela Lipscomb    919-843-3670    markeela_lipscomb@med.unc.edu   
Principal Investigator: Clayton Commander, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Jessica K Stewart, MD University of California, Los Angeles
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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: October 15, 2019    Key Record Dates
Last Update Posted: March 28, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of California, Los Angeles:
Uterine Artery Embolization
Additional relevant MeSH terms:
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Leiomyoma
Adenomyosis
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Uterine Diseases
Triamcinolone
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists