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

Abstract

BackgroundXaraColl, 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.MethodsWe 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.ResultsXaraColl 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.ConclusionXaraColl 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.

Drug delivery systems for prolonged duration local anesthesia

“…Recent examples have included a liposomal bupivacaine formulation (Exparel®) from Pacira Pharmaceuticals; [68-74] bupivacaine formulation (Posimir®) described as an esterified sugar derivative on the Durect website;[116] a poly(ortho ester) formulation of bupivacaine and the anti-inflammatory drug meloxicam (HTX-011) from Heron Therapeutics;[117,118] and a collagen-based implantable bupivacaine release system (XaraColl ®) from Innocoll. [119-121] A review focused on the engineering of sustained release systems is not the best place to review the comparative merits of commercial products, their tribulations with regulatory bodies, or to review clinical trials. Moreover, the abovementioned difficulties in comparing formulations in animals can be true of human trials as well.…”

The pharmacokinetics and safety of an intraoperative bupivacaine-collagen implant (XaraColl®) for postoperative analgesia in women following total abdominal hysterectomy

“…Randomized controlled trials performed in women undergoing open gynecological surgery3 and in men undergoing hernioplasty4 have concluded that XaraColl is effective in reducing patient use of opioid analgesia and/or their pain intensity for up to 3 or 4 days postoperatively. The product also offers great versatility and is already proven suitable for use in laparoscopic surgery 5. The primary objective of this study was to characterize XaraColl’s pharmacokinetic profile and elucidate its mechanism of drug release in vivo.…”