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Effect of Addition of Steroids on Duration of Analgesia

Primary Purpose

Uterine Fibroids, Adenomyosis

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Triamcinolone

Bupivacaine

Iohexol contrast

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine Artery Embolization

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts 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

Sites / Locations

University of North CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bupivacaine

Bupivacaine and Triamcinolone

Arm 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.

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Full Information

NCT ID

NCT04126824

First Posted

October 7, 2019

Last Updated

March 25, 2022

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT04126824

Brief Title

Effect of Addition of Steroids on Duration of Analgesia

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 5, 2019 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroids, Adenomyosis

Keywords

Uterine Artery Embolization

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine

Arm Type

Active Comparator

Arm 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.

Arm Title

Bupivacaine and Triamcinolone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Triamcinolone

Other Intervention Name(s)

Kenalog

Intervention Description

40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Marcaine, Exparel

Intervention Description

0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).

Intervention Type

Other

Intervention Name(s)

Iohexol contrast

Other Intervention Name(s)

Omnipaque

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Pain Intensity Measure (mm)

Description

Time Frame

Baseline, 240 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tammy L Floore

Phone

310-794-9202

tfloore@mednet.ucla.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Saima Chaabane

Phone

310-794-8995

schaabane@mednet.ucla.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica K Stewart, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hannah Mignosa

Phone

984-215-4963

hannah_mignosa@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Markeela Lipscomb

Phone

919-843-3670

markeela_lipscomb@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Clayton Commander, MD

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Addition of Steroids on Duration of Analgesia

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