NCT01143025

Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: San Gerardo Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 50 mg, 100 mg or 150 mg may prevent the use of morphine during the first day after laparoscopic cholecystectomy.

Detailed description

Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy has been proved to significantly reduce postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting in comparison with patients receiving direct instillation of Bupivacaine 50 mg or placebo. Ropivacaine can be effectively administrated with non-heating nebulizers (AeronebPro®). In a recent study our group found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy significantly reduced postoperative pain and morphine consumption. Nonetheless, most patients still need strong opioid based analgesia after surgery. We hypothesize that intraperitoneal nebulization of Ropivacaine 100 mg and 150 mg (maximum recommended dose in adults 300 mg or up to 3 mg/kg) may prevent the use of morphine during the first day after surgery maintaining ropivacaine plasma levels below toxic concentration.

Conditions

• Laparoscopic Cholecystectomy

Interventions

Type	Name	Description
DRUG	Ropivacaine 50 mg	Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
DRUG	Ropivacaine 100 mg	Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
DRUG	Ropivacaine 150 mg	Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2010-06-14
• Last updated: 2011-05-19

Locations

1 site across 1 country: Italy