Effect of Addition of Steroids on Duration of Analgesia

University of California, Los Angeles (UCLA)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Uterine Fibroids; Adenomyosis

Treatments: Drug: Triamcinolone; Drug: Bupivacaine; Other: Iohexol contrast

Study type: Interventional

Funder types: Other

Identifiers

NCT04126824

21-001880

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Bupivacaine

Active Comparator group

Description:

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

Treatment:

Other: Iohexol contrast

Drug: Bupivacaine

Bupivacaine and Triamcinolone

Experimental group

Description:

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.

Treatment:

Other: Iohexol contrast

Drug: Bupivacaine

Drug: Triamcinolone