Baclofen for Post-Surgical Pain

Recruiting in Palo Alto (17 mi)

Overseen ByMark Mandabach, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Alabama at Birmingham

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

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

Eligibility Criteria

This trial is for adults aged 19 or older who are scheduled for kidney stone surgery. It's not suitable for those allergic to baclofen or with conditions that could affect their ability to report and manage post-surgery pain, such as severe psychiatric disorders or language barriers.

Inclusion Criteria

I am 19 or older and scheduled for kidney stone surgery.

Participant Groups

The study is testing if a single oral dose of baclofen (10mg) can reduce the need for opioids after surgery. Participants will either receive baclofen or a placebo without knowing which one they're getting.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Opioid Tolerant - baclofenExperimental Treatment1 Intervention

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.

Group II: Opioid Naive - baclofenExperimental Treatment1 Intervention

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.

Group III: Opioid Naive - placeboPlacebo Group1 Intervention

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.

Group IV: Opioid Tolerant - placeboPlacebo Group1 Intervention

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.