Objectives: To evaluate whether liposomal bupivacaine provides superior postoperative analgesia compared with ropivacaine following haemorrhoidectomy, reduces the need for rescue analgesics in patients with mixed haemorrhoids and maintains a comparable safety profile.
Design: Prospective, randomised controlled multicentre trial.
Setting: Three grade 3A general hospitals in Guangxi, China, conducted between September 2023 and July 2024.
Participants: Eligible patients were aged 18-75 years undergoing elective external dissection and internal ligation for mixed haemorrhoids (grade III and IV mixed haemorrhoids). Key exclusion criteria were severe systemic diseases, history of substance abuse or known allergies to local anaesthetics. A total of 264 patients (male, n=162; mean age, 43.1±12.2 years) were enrolled and completed the study, with 132 randomised to each group.
Interventions: Patients received either ropivacaine (100 mg in 20 mL) or liposomal bupivacaine (226 mg in 20 mL) through local infiltration at the end of surgery.
Primary and secondary outcome measures: The primary outcomes were the resting numerical rating scale (NRS) pain scores (0-10) at postoperative 1, 5, 7, 9, 11, 24, 36, 48 and 72 hours. The secondary outcomes included the following: (1) exercise NRS pain scores at the same time points; (2) time to first ambulation, ambulation NRS pain scores on postoperative days 1, 2 and 3 and the proportion of patients having ambulation NRS pain scores ≥4; (3) defecation NRS pain scores and the proportion of of patients having score ≥4; (4) the time to the first administration of rescue analgesics and proportion of patients requiring rescue analgesics; (5) proportion of pain-free patients (NRS pain scores ≤1) 0-24, 24-72 and 0-72 hour after surgery; (6) incision assessments on postoperative days 1, 3 and 7 and postoperative adverse events (AEs); and (7) patients' and researchers' satisfaction with pain management.
Results: Resting NRS pain scores were significantly lower in the liposomal bupivacaine group at all time points (median, 0-2.0 vs 2.0-4.0 for ropivacaine, p<0.001). Exercise NRS pain scores were also significantly lower in the liposomal bupivacaine group (median, 0-2.0 vs 2.0-5.0, p<0.001). Additionally, median ambulation NRS pain scores were reduced in the liposomal bupivacaine group on postoperative days 1-3 (median, 1.0-2.0 vs 3.0-5.0, p<0.001). By 72 hours after surgery, 78.8% of the patients in the liposomal bupivacaine group had defecated, reporting lower defecation NRS pain scores (median, 3.0 vs 5.0, p<0.001). Fewer patients in this group required rescue analgesics (43.9% vs 83.3%, p<0.001). Incision assessment scores were comparable between groups, with no significant difference in AE rates (3.8% vs 1.5%, p=0.444).
Conclusions: Perianal infiltration of liposomal bupivacaine significantly alleviates postoperative resting and exercise pain in patients undergoing surgery for mixed haemorrhoids, enhances comfort during ambulation and defecation, reduces the need for additional analgesics and demonstrates a safety profile comparable to that of ropivacaine.
Trial registration: chictr.org.cn # ChiCTR2300075276.
Keywords: CLINICAL PHARMACOLOGY; PAIN MANAGEMENT; Pain management.
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