Baclofen as a Perioperative Analgesic Adjuvant

NCT03720717 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB-300002466
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Opioid Tolerant - baclofen

EXPERIMENTAL

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

Opioid Tolerant - placebo

PLACEBO COMPARATOR

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

Opioid Naive - baclofen

EXPERIMENTAL

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

Opioid Naive - placebo

PLACEBO COMPARATOR

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

Interventions

Baclofen 10mg DRUG

Baclofen administration pre-operatively

Also known as: Lioresol

Opioid Naive - baclofen; Opioid Tolerant - baclofen

Placebo OTHER

Placebo administration

Opioid Naive - placebo; Opioid Tolerant - placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Timothy J Ness MD PhD, Professor Emeritus
• Organization: University of Alabama at Birmingham

tness@uabmc.edu

2059079743

Study Officials

• Mark Mandabach, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Coded envelopes as described above
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Model Details: Coded envelopes with study drug/placebo had been generated and randomized. Patients were enrolled and given drug in next envelope. After completion of study patients assigned into opioid-naive or daily opioid-tolerant groups based on history given by patient

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: October 27, 2020
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Published - Cureus 2024 - DOI: 10.7759/cureus
• Access Criteria: published

Locations

US (1)