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

BACKGROUND: Rubber band ligation of hemorrhoids causes less pain than excisional hemorrhoidectomy, but many patients still experience significant post-procedure discomfort.

OBJECTIVE: This study aims to determine if topical lidocaine, with or without diltiazem, is more effective than placebo for analgesia following hemorrhoid banding.

DESIGN: This is a prospective, randomized, double-blinded, placebo controlled trial. Patients were randomized to 2% lidocaine, 2% lidocaine with 2% diltiazem, or placebo ointment.

SETTINGS: This study was performed at two university public teaching hospitals and 2 private hospitals in Australia.

PATIENTS: Consecutive patients aged ≥18 years undergoing hemorrhoid banding were selected.

INTERVENTIONS: Topical ointments were applied post-procedure 3 times daily for 5 days.

MAIN OUTCOME MEASURES: Visual analogue pain score, opiate analgesia usage, and patient satisfaction were the main outcome measures.

RESULTS: 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.

LIMITATIONS: 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.

CONCLUSION: Topical lidocaine improves short-term analgesia, while combination lidocaine/diltiazem is associated with both improved analgesia and patient satisfaction following hemorrhoid banding.

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