IPLA

Intraperitoneal atomization of levobupivacaine during gynecological laparoscopic procedures : Impact on pain, opioid use and length of recovery room stay (IPLA)

Laparoscopic surgery has replaced open surgical techniques for a large number of abdominal general surgical and gynecologic interventions. However pain following laparoscopic surgery continues to be a clinically important problem, especially in one-day surgery.
In this study, we will compare 3 treatments. The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine). The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery . The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. We will use non-diluted 0.5% levobupivacaine delivered directly onto the target sites both at the beginning and the end of surgery. The drug will be delivered using OptiSpray® surgical spray device, an inexpensive delivery system that will direct a fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).
Our primary goal is to assess the efficacy of intraperitoneal atomization of levobupivcaine in reducing postoperative pain and of opioid requirements in patients undergoing gynecological laparoscopic procedures in one-day surgery.

  • Investigators UZ Gent : Dr. M. Coppens, Prof. Dr. S. Weyers, Dr. K. Fonck, Dr. A Vanluchene, Dr. M. Neckebroek, Dr. N. Van Den Eynde
  • Timeline : start inclusion June 2013, 1-2 years
  • Clinical Trial.gov identifier : NCT01886352