Pain, Postoperative Clinical Trial
Official title:
Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).
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 levobupivacaine
in reducing postoperative pain and of opioid requirements in patients undergoing
gynecological laparoscopic procedures in one-day surgery.
n/a
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