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NCT03720717 Clinical Trial

Baclofen as a Perioperative Analgesic Adjuvant

Pain Clinical Trial

Official title:
Baclofen as a Perioperative Analgesic Adjuvant

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03720717
Other study ID # IRB-300002466
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 17, 2019
Est. completion date September 14, 2024

Study information
Verified date September 2023
Source University of Alabama at Birmingham
Contact Adam B Sturdivant, MPH
Phone 205-934-4042
Email Adamsturdivant@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.

Description:

Postoperative pain continues to be a significant clinical problem. Use of perioperative adjuvants has improved postoperative pain control. The GABA-B receptor agonist, baclofen, is an appropriate drug to trial as such an analgesic adjuvant. Therefore, the investigators will conduct a study designed to determine whether or not a single, oral dose of baclofen given to patients undergoing kidney stone surgery will reduce postoperative opioid requirements measured in the first 24 hours following surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 86
Est. completion date September 14, 2024
Est. primary completion date September 14, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Adult patients (age >= 19 y.o.) scheduled for kidney stone-related surgery Exclusion Criteria: - History of allergy to baclofen - Any condition which might limit appropriate report and treatment of postoperative pain (e.g., non-English speaking; severe psychiatric disease)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Baclofen 10mg
Baclofen administration pre-operatively
Other:
• Placebo
Placebo administration

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Opioid Requirements Patients Patients' opioid requirements for acceptable pain control will be assessed based on the total oral morphine equivalent needed for post operative pain control. From 0 hours post-operatively to 24 hours post-operatively
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