Baclofen as a Perioperative Analgesic Adjuvant

Phase 4TerminatedNCT03720717

University of Alabama at Birmingham34 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

Baclofen 10mgDRUG

Baclofen administration pre-operatively

PlaceboOTHER

Placebo administration

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: From 0 hours post-operatively to 24 hours post-operatively

Data from ClinicalTrials.gov

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