NCT02641288

Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery

Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Hospital General Universitario Elche · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline (Control Group - CG).

Detailed description

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation 300mg in 200 ml(Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline 200ml (Control Group - CG).

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Ropivacaine irrigation	Using a standard irrigation device (no specific device is being used), 300 mg total of ropivacaine in 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces.
DRUG	Normal saline irrigation	Using a standard irrigation device (no specific device is being used), 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-12-29
• Last updated: 2015-12-29