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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 Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Masking Description
Coded envelopes as described above

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Baclofen 10mg
    Baclofen administration pre-operatively
    Other names:
    • Lioresol
Placebo Comparator
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.
  • Other: Placebo
    Placebo administration
Experimental
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.
  • Drug: Baclofen 10mg
    Baclofen administration pre-operatively
    Other names:
    • Lioresol
Placebo Comparator
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.
  • Other: Placebo
    Placebo administration

More Details

Status
Terminated
Sponsor
University of Alabama at Birmingham

Study Contact

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.