Topical Lidocaine or Lidocaine/Diltiazem Ointment Following Rubber Band Ligation of Hemorrhoids: A Prospective Three-Armed Randomized Controlled Trial.

Abstract

Rubber band ligation of hemorrhoids causes less pain than excisional hemorrhoidectomy, but many patients still experience significant post-procedure discomfort. This study aims to determine if topical lidocaine, with or without diltiazem, is more effective than placebo for analgesia following hemorrhoid banding. This is a prospective, randomized, double-blinded, placebo controlled trial. Patients were randomized to 2% lidocaine, 2% lidocaine with 2% diltiazem, or placebo ointment. This study was performed at two university public teaching hospitals and 2 private hospitals in Australia. Consecutive patients aged ≥18 years undergoing hemorrhoid banding were selected. Topical ointments were applied post-procedure 3 times daily for 5 days. Visual analogue pain score, opiate analgesia usage, and patient satisfaction were the main outcome measures. Of 159 eligible patients, 99 were randomized (33 in each group). Pain scores were reduced at 1 hour for the lidocaine (OR 4.15 [1.12-15.41] p = 0.03) and lidocaine/diltiazem groups (OR 3.85 (1.05-14.11), p = 0.04) compared with placebo. Patients in the lidocaine/diltiazem group had improved satisfaction (OR 3.82 [1.28-11.44], p = 0.02) and were more likely to recommend the procedure to others (OR 9.33 [1.07-81.72] p = 0.04). Patients in the lidocaine/diltiazem group required approximately 45% less total and in-hospital analgesia compared with placebo. There was no difference in complications between any of the groups. A cost/benefit analysis was not performed. Analgesic efficacy appeared to be short-term and the procedures were performed only in the hospital/non-ambulatory setting. Topical lidocaine improves short-term analgesia, while combination lidocaine/diltiazem is associated with both improved analgesia and patient satisfaction following hemorrhoid banding.