Effect of Addition of Steroids on Duration of Analgesia

Uterine Fibroids Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04126824
• Other study ID #: 21-001880
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 5, 2019
• Est. completion date: February 2025

Study information

• Verified date: March 2022
• Source: University of California, Los Angeles
• Contact: Tammy L Floore
• Phone: 310-794-9202
• Email: tfloore[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Triamcinolone
40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)
• Bupivacaine
0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).

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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity Measure (mm)	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".	Baseline, 240 hours