NCT01886352

Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Standard Injection of Levobupivacaine in portal sites.	All port sites will be injected with 0.1ml/kg levobupivacaine at the end of surgery, after trocar removal.
DRUG	Additional injection of 0,5% levobupivacaine.	Immediately following insufflation 0.15ml/kg levobupivacaine will be injected in the peritoneal cavity via a trocar. At the end of the surgery, this process will be repeated with the same dose at 0.15ml/kg.
DRUG	Intraperitoneal atomization of levobupivacaine.	Immediately following insufflation the Optispray® surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the study drug will be delivered as an atomized spray in the following volumes: 1. Each subdiaphragmatic area 0.05 ml/kg 2. Dome of abdomen then settling onto bowel 0.05 ml/kg 3. Surgical dissection site 0.05 ml/kg 4. At the end of the surgery - this process will be repeated with the same doses at 0.15 ml/kg.

Timeline

• Start date: 2013-06-26
• Primary completion: 2014-06-13
• Completion: 2018-12-03
• First posted: 2013-06-25
• Last updated: 2018-12-05

Locations

1 site across 1 country: Belgium