Conditions: Abdominal Pain Surgical Adhesions
Keywords: abdominal pain surgical adhesions
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

Detailed description:
The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption.

Arms:
arm 1: Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study. arm 2: Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.

Interventions: intervention 1: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks intervention 2: Placebo first followed by open label pregabalin
Intervention descriptions: intervention 1: First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID intervention 2: Look alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no improvement for 7 weeks. Open label pregabalin 150 mg BID for last 4 weeks of study.

Protocol document: