title: A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation.
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.
authors.affiliation: Colorectal Surgical Associates, Ltd, LLP, Houston, Texas, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Haas
authors.forename: Erol
authors.initials: E
authors.lastname: Onel
authors.forename: Howard
authors.initials: H
authors.lastname: Miller
authors.forename: Madhu
authors.initials: M
authors.lastname: Ragupathi
authors.forename: Paul F
authors.initials: PF
authors.lastname: White
mesh_terms: D000698:Analgesia / Q000379:methods*; D000700:Analgesics; D000779:Anesthetics, Local / Q000008:administration & dosage*; D002045:Bupivacaine / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006484:Hemorrhoids / Q000601:surgery*; D006801:Humans; D007267:Injections; D008081:Liposomes; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis / Q000188:drug therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000779:Anesthetics, Local; D008081:Liposomes; D002045:Bupivacaine