Effect of Addition of Steroids on Duration of Analgesia

Early Phase 1

Active, not recruiting

• Conditions: Uterine Fibroids; Adenomyosis
• Interventions: Drug: Bupivacaine; Drug: Triamcinolone; Other: Iohexol contrast

• Registration Number: NCT04126824
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Study Start: 2022-01-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (2)

University of California, Los Angeles; 🇺🇸 Westwood, California, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States