A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation

Am Surg. 2012 May;78(5):574-81. doi: 10.1177/000313481207800540.

Abstract

This randomized, active-controlled study evaluated the extent and duration of analgesia after administration of liposome bupivacaine (LB), a novel formulation of bupivacaine, compared with bupivacaine HCl given via local infiltration in excisional hemorrhoidectomy. One hundred patients were randomly assigned to receive a single dose of bupivacaine HCl 75 mg (0.25% with 1:200,000 epinephrine) or LB 66, 199, or 266 mg upon completion of hemorrhoidectomy. Postoperative pain intensity was assessed using a numeric rating scale at rest to calculate a cumulative pain score (area under the curve). Cumulative pain scores were significantly lower with LB at each study dose (P < 0.05) compared with bupivacaine HCl 72 hours after surgery. Post hoc analysis showed that mean total postoperative opioid consumption was statistically significantly lower for the LB 266-mg group compared with the bupivacaine HCl group during the 12- to 72-hour postoperative period (P = 0.019). Median time to first opioid use was 19 hours for LB 266 mg versus 8 hours for bupivacaine HCl (P = 0.005). Incidence of opioid-related adverse events was 4 per cent for LB 266 mg compared with 35 per cent for bupivacaine HCl (P = 0.007). Local infiltration with LB resulted in significantly reduced postsurgical pain compared with bupivacaine HCl in patients after hemorrhoidectomy surgery.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Analgesia / methods*
  • Analgesics
  • Anesthetics, Local / administration & dosage*
  • Bupivacaine / administration & dosage*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Follow-Up Studies
  • Hemorrhoids / surgery*
  • Humans
  • Injections
  • Liposomes
  • Pain Management / methods*
  • Pain Measurement
  • Pain, Postoperative / diagnosis
  • Pain, Postoperative / drug therapy*
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Analgesics
  • Anesthetics, Local
  • Liposomes
  • Bupivacaine