Pregabalin for the treatment of abdominal adhesion pain:  a randomized, double-blind, placebo-controlled trial.
Chronic pain related to postoperative abdominal adhesions is a common problem with no standard analgesic regimen currently established. In a double-blind, placebo-controlled trial, we examined the effects of pregabalin on pain modulation in patients with prior abdominal surgery and documented adhesion. The primary outcome measure was pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption. A total of 18 women were randomized to receive either the drug (n = 11) or placebo (n = 7). Thirteen patients (eight pregabalin, five placebo) completed the blinded phase and 10 patients (seven pregabalin, three placebo) completed the open-label phase. Statistical analysis was performed in two settings: 1) Week 0 (as the baseline) through the end of Week 7 of the blinded fixed-dose phase; and 2) Week 7 (as the baseline) along With weeks 8 through 11 of the open-label phase. The pain score result from the blinded phase setting indicated that the amount of decrease was significantly greater in the drug group (P = 0.024), whereas the pain score result from the open-label setting indicated that the amount of decrease was significantly greater in the placebo group (P = 0.043). Only the sleep score result in the open-label setting was significantly greater in the placebo group (P = 0.024). We conclude that pregabalin significantly reduced patient-documented pain scores compared with placebo in our small cohort of patients with abdominal adhesion pain.
Division of Gastroenterology, Henry Ford Hospital, Detroit, MI 48202, USA. asilver1@hfhs.org
Ann
A
Silverman
Qiana
Q
Samuels
Helen
H
Gikas
Ali
A
Nawras
D000005:Abdomen / Q000473:pathology / Q000601:surgery; D015746:Abdominal Pain / Q000188:drug therapy* / Q000209:etiology; D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D011183:Postoperative Complications / Q000473:pathology; D000069583:Pregabalin; D012893:Sleep Wake Disorders / Q000209:etiology; D000267:Tissue Adhesions / Q000473:pathology; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid