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Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

Information source: San Gerardo Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Laparoscopic Cholecystectomy

Intervention: Ropivacaine 50 mg (Drug); Ropivacaine 100 mg (Drug); Ropivacaine 150 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: San Gerardo Hospital

Official(s) and/or principal investigator(s):
Massimo Allegri, MD, Study Chair, Affiliation: Servizio Anestesia e Rianimazione I e Terapia del Dolore, Fondazione IRCCS Policlinico San Matteo, Pavia
Mario Regazzi, MD, Study Chair, Affiliation: Head of Clinical PK and TDM Laboratory, Foundation IRCCS Policlinico San Matteo, Pavia
Ernesto Pizzirani, MD, Study Chair, Affiliation: U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova
Fiorenza Franceschi, MD, Study Chair, Affiliation: U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova
Armando Alborghetti, MD, Study Chair, Affiliation: U.O.C. Anestesia e Rianimazione. Ospedale di Ponte San Pietro. Bergamo
Alessandro Albani, MD, Study Chair, Affiliation: U.O. Anestesia e Rianimazione. Ospedale Regionale "U. Parini", Aosta
Pierre Diemusch, MD, Study Chair, Affiliation: Servizio di Anestesia e rianimazione chirurgica. Hospital de Hautepierre. Università di Strasburgo.


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.

Clinical Details

Official title: Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy

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

Primary outcome: Morphine consumption (mg)

Secondary outcome:

Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine

Ropivacaine pharmacokinetics profile: Tissue drug analysis

Postoperative Pain

Time of unassisted walking

Hospital morbidity

Time and condition for hospital discharge

Quality of life after surgery

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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Females and Males 18-75 years old

- ASA Score I-III

- Scheduled for laparoscopic cholecystectomy

- Free from pain in preoperative period

- Not using analgesic drugs before surgery

- Without cognitive impairment or mental retardation

- Written informed consent

Exclusion Criteria:

- Emergency/urgency surgery

- Postoperative admission in an intensive care unit

- Cognitive impairment or mental retardation

- Progressive degenerative diseases of the CNS

- Seizures or chronic therapy with antiepileptic drugs

- Severe hepatic or renal impairment

- Pregnancy or lactation

- Allergy to one of the specific drugs under study

- Acute infection or inflammatory chronic disease

- Alcohol or drug addiction

Locations and Contacts

San Gerardo Hospital, Monza, MB 20052, Italy
Additional Information

Related publications:

Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013e318176fa1c.

Schlotterbeck H, Schaeffer R, Dow WA, Diemunsch P. Cold nebulization used to prevent heat loss during laparoscopic surgery: an experimental study in pigs. Surg Endosc. 2008 Dec;22(12):2616-20. doi: 10.1007/s00464-008-9841-z. Epub 2008 Mar 18.

Starting date: March 2010
Last updated: May 18, 2011

Page last updated: August 23, 2015

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