A feasibility study to investigate the use of a bupivacaine-collagen implant (XaraColl) for postoperative analgesia following laparoscopic surgery

Abstract

Lisa Hemsen,1 Susan L Cusack,2 Harold S Minkowitz,3 Michael E Kuss41Innocoll Technologies, Athlone, Ireland; 2Cusack Pharmaceutical Consulting, Burlington, NJ, USA; 3Memorial Hermann Memorial City Medical Center, Houston, TX, USA; 4Premier Research Group, Austin, TX, USABackground: XaraColl, a collagen-based implant that delivers bupivacaine to sites of surgical trauma, has been shown to reduce postoperative pain and use of opioid analgesia in patients undergoing open surgery. We therefore designed and conducted a preliminary feasibility study to investigate its application and ease of use for laparoscopic surgery.Methods: We implanted four XaraColl implants each containing 50 mg of bupivacaine hydrochloride (200 mg total dose) in ten men undergoing laparoscopic inguinal or umbilical hernioplasty. Postoperative pain intensity and use of opioid analgesia were recorded through 72 hours for comparison with previously reported data from efficacy studies performed in men undergoing open inguinal hernioplasty. Safety was assessed for 30 days.Results: XaraColl was easily and safely implanted via a laparoscope. The summed pain intensity and total use of opioid analgesia through the first 24 hours were similar to the values observed in previously reported studies for XaraColl-treated patients after open surgery, but were lower through 48 and 72 hours.Conclusion: XaraColl is suitable for use in laparoscopic surgery and may provide postoperative analgesia in laparoscopic patients who often experience considerable postoperative pain in the first 24–48 hours following hospital discharge. Randomized controlled trials specifically to evaluate its efficacy in this application are warranted.Keywords: laparoscopic, hernioplasty, hernia repair