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

PHASE4CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

June 26, 2013

Primary Completion Date

June 13, 2014

Study Completion Date

December 3, 2018

Conditions
Pain, Postoperative
Interventions
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."

Trial Locations (1)

9000

Ghent University Hospital, Ghent

All Listed Sponsors
lead

University Hospital, Ghent

OTHER

NCT01886352 - Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA). | Biotech Hunter | Biotech Hunter