Print

Purpose

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

Condition

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.