This randomized, double-blind, active controlled multi-modal study compared the efficacy and tolerability of 3 dosages of EXPAREL® (bupivacaine liposome injectable suspension; Pacira pharmaceuticals, Parsippany, NJ) with bupivacaine HCl 75 mg with epinephrine 1:200,000 administered intra-operatively via wound infiltration for postsurgical pain relief in patients undergoing excisional hemorrhoidectomy. In these patients, liposome bupivacaine was shown to provide significantly greater pain relief after surgery with less use of opioid rescue medications and fewer opioid related adverse events than bupivacaine HCl. A single administration of the commercially available dose of liposome bupivacaine (266 mg; n=25) was associated with a mean 47% relative reduction in cumulative pain score and 66% relative reduction in amount of opioid medication consumed; a blinded post-hoc analysis using a definition of opioid related adverse events (ORAEs) similar to one already agreed to by the FDA demonstrated an 89% reduction in ORAEs compared with bupivacaine HCl (P<0.01 for all comparisons)
A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation.
The American surgeon 2012 May 1; 78(5):574-81
Haas E, Onel E, Miller H, Ragupathi M, White PF
Colorectal Surgical Associates, Ltd, LLP, Houston, Texas, USA.
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.