Pregabalin for Abdominal Pain From Adhesions

Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial

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

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.

Inclusion Criteria:

• Must have history of prior surgery and documented adhesions during laparoscopy or open laparotomy within 5 years
• Must have undergone an evaluation to exclude other causes of abdominal pain
• Abdominal pain must be present for greater than three months duration

Exclusion Criteria:

• Patients that are pregnant or breast feeding
• Prior treatment with gabapentin, pregabalin or demonstrated sensitivity to these drugs
• Patients who are immunocompromised
• Patients with significant hepatic or renal insufficiency, or any significant hematologic disorder
• History of illicit alcohol or drug abuse within one year
• Documented serious or unstable medical or psychological condition
• Malignancy within the past 5 years other than in situ squamous cell carcinoma of the skin