Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial.

ABSTRACT

BACKGROUND: Baclofen is an agonist for a subtype of gamma-amino butyric acid (GABA-B) receptors and traditionally been used for the systemic treatment of spasticity. Topical application of baclofen has been shown to reduce pain in patients with localized neuropathic pain. OBJECTIVES: In this study, we investigate the efficacy of baclofen cream (5%) in reducing postoperative pain and analgesic requirement after open hemorrhoidectomy. DESIGN: The patients were randomly assigned to either baclofen (5%) cream or placebo immediately after surgery and then every 12 h for 14 days. PATIENTS A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were randomly assigned to this trial. SETTING: This study was conducted at a single educational hospital. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were intensity of pain, measured with a visual analog scale, and the analgesic requirement, measured by the amount of the acetaminophen consumption. RESULTS: No significant difference was found in baseline characteristics between the two groups. Postoperative pain score of the baclofen group was significantly lower on week 1 (P = 0.01) and week 2 (P = 0.02) than the placebo group. Similarly, patients in the baclofen group consumed significantly less analgesic medication on week 1 (P = 0.025) and week 2 (P = 0.024) than the control group. CONCLUSION: Topical application of baclofen effectively relieves pain after hemorrhoidectomy with minimal side effects.