Pregabalin for Abdominal Pain From Adhesions
Condition: Abdominal Pain; Surgical Adhesions
MeSH terms: Tissue Adhesions; Abdominal Pain
Intervention: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks; Placebo first followed by open label pregabalin
Intervention description: 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; 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.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients were evaluated for the study and were entered into the study if they had documented abdominal adhesions and a daily pain score of 40 mm on a visual assessment scale and 4 on an eleven point Likert scale (0 none and 10 most pain). Patients were randomly assigned to active drug or look alike placebo for 7 weeks followed by an open label phase in which all patients received active drug pregabalin 300 mg daily for 4 weeks measuring pain and sleep scores during each phase of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blinding was done to ensure minimum bias. Clinicians were not involved in the randomization process. Patients and clinicians were blinded to the identity of the drug as a look alike placebo was used. The randomization code was was maintained by the research assistant and kept in a locked file cabinet. Separated individuals generated the allocation sequence. The blind was maintained until all the decisions regarding data evaluability were made or in the event of a serious adverse event.
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: abdominal pain; surgical adhesions

Summary:

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

Eligibility criteria:

        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