Effect of Addition of Steroids on Duration of Analgesia

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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

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 Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Change in Pain Intensity Measure (mm)


Condition

Uterine Fibroids

Intervention

Triamcinolone

Study Arms / Comparison Groups

 Bupivacaine
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

28

Start Date

November 5, 2019

Completion Date

June 2021

Primary Completion Date

June 2021

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
      

Gender

Female

Ages

30 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jessica Stewart, MD, 984-215-4963, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04126824

Organization ID

19-1296


Responsible Party

Sponsor

Study Sponsor

University of North Carolina, Chapel Hill


Study Sponsor

Jessica Stewart, MD, Principal Investigator, University of North Carolina


Verification Date

December 2020