Baclofen as a Perioperative Analgesic Adjuvant
Overview
- Phase
- Phase 4
- Intervention
- Baclofen 10mg
- Conditions
- Pain
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Postoperative Opioid Requirements
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.
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.
Investigators
Timothy Ness, MD
Prinicipal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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)
Arms & Interventions
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.
Intervention: Baclofen 10mg
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.
Intervention: Placebo
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.
Intervention: Baclofen 10mg
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.
Intervention: Placebo
Outcomes
Primary Outcomes
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.