Baclofen as a Perioperative Analgesic Adjuvant

August 29, 2024 updated by: Timothy Ness, MD, University of Alabama at Birmingham
The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (age >= 19 y.o.) scheduled for kidney stone-related surgery

Exclusion Criteria: (note - there were no patients requiring exclusion)

  • 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)
  • Active history of cancer
  • Potential for difficult airway as judged by attending anesthesiologist due to concerns there could be muscle weakness from the drug with consequent respiratory depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Opioid Tolerant - baclofen
Patients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry. Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
Drug: Baclofen 10mg
Baclofen administration pre-operatively
Other Names:
  • Lioresol
Placebo Comparator: Opioid Tolerant - placebo
Patients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
Other: Placebo
Placebo administration
Experimental: Opioid Naive - baclofen
Patients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
Drug: Baclofen 10mg
Baclofen administration pre-operatively
Other Names:
  • Lioresol
Placebo Comparator: Opioid Naive - placebo
Patients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
Other: Placebo
Placebo administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Opioid Requirements
Time Frame: From 0 hours post-operatively to 24 hours post-operatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Mark Mandabach, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

October 28, 2022

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300002466

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual data available on reasonable request - currently in RedCap system

IPD Sharing Time Frame

Published - Cureus 2024 - DOI: 10.7759/cureus

IPD Sharing Access Criteria

published

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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