Conditions: Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 34
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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.

Interventions: intervention 1: Baclofen 10mg intervention 2: Placebo
Intervention descriptions: intervention 1: Baclofen administration pre-operatively intervention 2: Placebo administration

Protocol document:
Prot_SAP_002.pdf: 





















ICF_004.pdf: