Introduction: Rubber band ligation (RBL) is a procedure commonly performed in colorectal clinics for internal haemorrhoids. Overall, 90% of patients experience pain following RBL. We aimed to complete a feasibility randomised control trial assessing the role of topical anaesthetic before RBL of internal haemorrhoids.
Methods: We performed a prospective, single-centre, single blinded, randomised (1:1) control feasibility trial. Patients presenting with symptomatic haemorrhoids suitable for banding were randomised to undergo the procedure with local anaesthetic or without (control). Pain scores and vasovagal symptoms were assessed at 0 minutes, 30 minutes, 4 hours and 72 hours after the procedure. Primary outcome measures were recruitment rate, participant retention rate and patient and surgeon acceptability. Secondary outcome measures were pain scores up to 72 hours, vasovagal episodes, new use of analgesia and adverse outcomes.
Results: In total, 35 patients (18 topical anaesthetic, group A; 17 no anaesthetic gel, group B) were recruited. Mean recruitment rate was 11.7 participants per month. Thirty-three (94%) participants remained in the study until completion, with two patients lost to telephone follow-up. The treatment was acceptable for 35 (97%) eligible patients. One patient declined enrolment. The treatment was acceptable to all surgeons (100%). There was a significant difference in median pain scores of -2 (95% CI -4.0 to -1.0, p=0.0006) at the 30-minute time point only. There was no significant difference in vasovagal symptoms (p=0.10) or new analgesia use (p=0.85).
Conclusion: We have shown that a phase III clinical trial is feasible for assessing the role of topical anaesthetic before RBL of internal haemorrhoids. We have demonstrated excellent patient recruitment and retention as well as patient and surgeon acceptability.
Keywords: Analgesia; Haemorrhoids; Pain; Rubber band ligation.