Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

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.

Conditions

• Laparoscopic Cholecystectomy

Interventions

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

Sponsors & Collaborators

• University of Milano Bicocca

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Azienda L'ULSS 15 Alta Padovana

  collaborator OTHER

• Gruppo Ospedaliero San Donato, Policlinico San Pietro, Ponte San Pietro, Bergamo

  collaborator UNKNOWN

• Azienda U.S.L. della Valle d'Aosta, Ospedale Regionale Umberto Parini

  collaborator UNKNOWN

• San Gerardo Hospital

  lead OTHER

Principal Investigators

• Massimo Allegri, MD · Servizio Anestesia e Rianimazione I e Terapia del Dolore, Fondazione IRCCS Policlinico San Matteo, Pavia

• Mario Regazzi, MD · Head of Clinical PK and TDM Laboratory, Foundation IRCCS Policlinico San Matteo, Pavia

• Ernesto Pizzirani, MD · U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova

• Fiorenza Franceschi, MD · U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova

• Armando Alborghetti, MD · U.O.C. Anestesia e Rianimazione. Ospedale di Ponte San Pietro. Bergamo

• Alessandro Albani, MD · U.O. Anestesia e Rianimazione. Ospedale Regionale "U. Parini", Aosta

• Pierre Diemusch, MD · Servizio di Anestesia e rianimazione chirurgica. Hospital de Hautepierre. Università di Strasburgo.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2011-04-30

Completion

2011-05-31

Countries

• Italy

Study Locations