Baclofen as a Perioperative Analgesic Adjuvant

Purpose

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

Condition

  • Pain

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Opioid Tolerant - baclofen
  • Drug: Baclofen 10mg
    Baclofen administration pre-operatively
Placebo Comparator
Opioid Tolerant - placebo
  • Other: Placebo
    Placebo administration
Experimental
Opioid Naive - baclofen
  • Drug: Baclofen 10mg
    Baclofen administration pre-operatively
Placebo Comparator
Opioid Naive - placebo
  • Other: Placebo
    Placebo administration

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Adam B Sturdivant, MPH
205-934-4042

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Adam B Sturdivant, MPH
205-934-4042
Adamsturdivant@uabmc.edu

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.