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

Lisa Hemsen, Susan L Cusack, Harold S Minkowitz, Michael E Kuss, Lisa Hemsen, Susan L Cusack, Harold S Minkowitz, Michael E Kuss

Abstract

Background: 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: hernia repair; hernioplasty; laparoscopic.

Figures

Figure 1
Figure 1
XaraColl (Innocoll Technologies, Athlone, Ireland).

References

    1. Roumm AR, Pizzi L, Goldfard NI, Cohn H. Minimally invasive: minimally reimbursed? An examination of six laparoscopic surgical procedures. Surg Innov. 2005;12(3):261–287. Erratum in Surg Innov. 2006;13(1):16.
    1. Harrell AG, Heniford BT. Minimally invasive abdominal surgery: lux et veritas past, present, and future. Am J Surg. 2005;190(2):239–243.
    1. Martel G, Boushey RP. Laparoscopic colon surgery: past, present and future. Surg Clin North Am. 2006;86(4):867–897.
    1. Cullen KA, Hall J, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009;11:1–28.
    1. Rawal N, Hylander J, Nydahl PA, Olofsson I, Gupta A. Survery of postoperative analgesia following ambulatory surgery. Acta Anaesthesiol Scand. 1997;41(8):1017–1022.
    1. Beauregard L, Pomp A, Choinière M. Severity and impact of pain after day-surgery. Can J Anaesth. 1998;45(4):304–311.
    1. McGrath B, Elgendy H, Chung F, Kamming D, Curti B, King S. Thirty percent of patients have moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. Can J Anaesth. 2004;51(9):886–891.
    1. Cusack S, Reginald P, Hemsen L, Umerah E. The pharmacokinetics and safety of an intraoperative bupivacaine-collagen implant (XaraColl®) for postoperative analgesia in women following total abdominal hysterectomy. J Pain Res. 2013
    1. Cusack S, Jaros M, Kuss M, Minkowitz H, Winkle P, Hemsen L. Clinical evaluation of a bupivacaine-collagen implant (XaraColl®) for postoperative analgesia from two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217–225.
    1. Cusack S, Jaros M, Kuss M, Minkowitz H, Hemsen L. A randomized, multicenter, pilot study comparing the efficacy and safety of a bupivacaine-collagen implant (XaraColl®) with the ON-Q PainBuster® post-op relief system following open gynecological surgery. J Pain Res. 2012;5:1–9.
    1. Gordon DB, Stevenson KK, Griffie J, Muchka S, Rapp C, Ford-Roberts K. Opioid equianalgesic calculations. J Palliat Med. 1999;2(2):209–218.
    1. Treadwell J, Tipton K, Oyesanmi O, Sun F, Schoelles K. Surgical options for inguinal hernia: comparative effectiveness review. Comparative Effectiveness Reviews. 2012;70
    1. Johansson B, Hallerbäck B, Glise H, Anesten B, Smedberg S, Román J. Laparoscopic mesh versus open preperitoneal mesh versus conventional technique for inguinal hernia repair: a randomized multicenter trial (SCUR Hernia Repair Study) Ann Surg. 1999;230(2):225–231.
    1. McCormack K, Scott NW, Go PM, Ross S, Grant AM. EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2003;(1):CD001785.
    1. Grant AM. EU Hernia Trialists Collaboration. Laparoscopic versus open groin hernia repair: meta-analysis of randomised trials based on individual patient data. Hernia. 2002;6(1):2–10.
    1. Winslow ER, Quasebarth M, Brunt LM. Perioperative outcomes and complications of open vs laparoscopic extraperitoneal inguinal hernia repair in a mature surgical practice. Surg Endosc. 2004;18(2):221–227.
    1. Gonzalez R, Mason E, Duncan T, Wilson R, Ramshaw BJ. Laparoscopic versus open umbilical hernia repair. JSLS. 2003;7(4):323–328.
    1. Lau H, Patil NG. Umbilical hernia in adults. Surg Endosc. 2003;17(12):2016–2020.
    1. Lomanto D, Iyer SG, Shabbir A, Cheah WK. Laparoscopic versus open ventral hernia mesh repair: a prospective study. Surg Endosc. 2006;20(7):1030–1035.
    1. Wright BE, Beckerman J, Cohen M, Cumming JK, Rodriguez JL. Is laparoscopic umbilical hernia repair with mesh a reasonable alternative to conventional repair? Am J Surg. 2002;184(6):505–508. discussion 508–5090.
    1. Neumayer L, Giobbie-Hurder A, Jonasson O, et al. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004;29:350(18):1819–1827.
    1. Bar-Dayan A, Natour M, Bar-Zakai B, Zmora O, et al. Preperitoneal bupivacaine attenuates pain following laparoscopic inguinal hernia repair. Surg Endosc. 2004;18(7):1079–1081.
    1. Chauvin M. State of the art of pain treatment following ambulatory surgery. Eur J Anaesthesiol Suppl. 2003;28:3–6.
    1. Elvir-Lazo OL, White PF. Postoperative pain management after ambulatory surgery: role of multimodal analgesia. Anesthesiol Clin. 2012;28(2):217–224.
    1. Hon SF, Poon CM, Leong HT, Tang YC. Pre-emptive infiltration of bupivacaine in laparoscopic total extraperitoneal hernioplasty: a randomized controlled trial. Hernia. 2009;13(1):53–56.
    1. Suvikapakornkul R, Valaivarangkul P, Noiwan P, Phansukphon T. A randomized controlled trial of preperitoneal bupivacaine instillation for reducing pain following laparoscopic inguinal herniorrhaphy. Surg Innov. 2009;16(2):117–1123.
    1. Saff GN, Marks RA, Kuroda M, Rozan J P, Hertz R. Analgesic effect of bupivacaine on extraperitoneal laparoscopic hernia repair. Anesth Analg. 1998;87(2):377–381.
    1. Abbas MH, Hamade A, Choudhry MN, Hamza N, Nadeem R, Ammori BJ. Infiltration of wounds and extraperitoneal space with local anesthetic in patients undergoing laparoscopic totally extraperitoneal repair of unilateral inguinal hernias: a randomized double-blind placebo-controlled trial. Scand J Surg. 2010;99(1):18–23.
    1. Enes H, Semir I, Sefik H, Husnija M, Goran I. Postoperative pain in open vs laparoscopic cholecystectomy with and without local application of anaesthetic. Med Glas Ljek komore Zenicko-doboj kantona. 2011;8(2):243–248.
    1. Mraović B, Jurisić T, Kogler-Majeric V, Sustic A. Intraperitoneal bupivacaine for analgesia after laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 1997;41(2):193–196.
    1. Pasqualucci A, de Angelis V, Contardo R, et al. Preemptive analgesia: intraperitoneal local anesthetic in laparoscopic cholecystectomy. A randomized, double-blind, placebo-controlled study. Anesthesiology. 1996;85(1):11–20.
    1. Barczyński M, Konturek A, Herman RM. Superiority of preemptive analgesia with intraperitoneal instillation of bupivacaine before rather than after the creation of pneumoperitoneum for laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. Surg Endosc. 2006;20(7):1088–1093.
    1. Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg. 1995;81(2):379–384.
    1. Jiranantarat V, Rushatamukayanunt W, Lert-akyamanee N, et al. Analgesic effect of intraperitoneal instillation of bupivacaine for postoperative laparoscopic cholecystectomy. J Med Assoc Thai. 2002;2085(Suppl 3):S897–S903.
    1. Zmora O, Stolik-Dollberg O, Bar-Zakai B, et al. Intraperitoneal bupivacaine does not attenuate pain following laparoscopic cholecystectomy. JSLS. 2000;4(4):301–304.
    1. Szem JW, Hydo L, Barie PS. A double-blinded evaluation of intraperitoneal bupivacaine vs saline for the reduction of postoperative pain and nausea after laparoscopic cholecystectomy. Surg Endosc. 1996;10(1):44–48.
    1. Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal use of local anesthetic in laparoscopic cholecystectomy: systematic review and metaanalysis of randomized controlled trials. J Hepatobiliary Pancreat Sci. 2010;17(5):637–656.
    1. Verma GR, Lyngdoh TS, Kaman L, Bala I. Placement of 0.5% bupivacaine-soaked Surgicel in the gallbladder bed is effective for pain after laparoscopic cholecystectomy. Surg Endosc. 2006;20(10):1560–1564.
    1. Scott NB. Wound infiltration for surgery. Anaesthesia. 2010;65(Suppl 1):67–75.
    1. Feroci F, Kröning KC, Scatizzi M. Effectiveness for pain after laparoscopic cholecystectomy of 0.5% bupivacaine-soaked Tabotamp placed in the gallbladder bed: a prospective, randomized, clinical trial. Surg Endosc. 2009;23(10):2214–2220.
    1. Cohen RV, Alvarez G, Roll S, et al. Transabdominal or totally extraperitoneal laparoscopic hernia repair? Surg Laparosc Endosc. 1998;8(4):264–268.
    1. McCormack K, Wake BL, Fraser C, Vale L, Perez J, Grant A. Transabdominal pre-peritoneal (TAPP) versus totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair: a systematic review. Hernia. 2005;9(2):109–114.

Source: PubMed

3
Iratkozz fel