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Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

2014-07-23 21:08:47 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Laparoscopic Cholecystectomy

Intervention

Ropivacaine 50 mg, Ropivacaine 100 mg, Ropivacaine 150 mg

Location

San Gerardo Hospital
Monza
MB
Italy
20052

Status

Recruiting

Source

San Gerardo Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:47-0400

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