Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery
NCT ID: NCT01143025
Last Updated: 2011-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2010-03-31
2011-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ropivacaine 50 mg
Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 50 mg
Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 100 mg
Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 100 mg
Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 150 mg
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 150 mg
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Interventions
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Ropivacaine 50 mg
Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 100 mg
Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 150 mg
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Azienda L'ULSS 15 Alta Padovana
OTHER
Gruppo Ospedaliero San Donato, Policlinico San Pietro, Ponte San Pietro, Bergamo
UNKNOWN
Azienda U.S.L. della Valle d'Aosta, Ospedale Regionale Umberto Parini
UNKNOWN
San Gerardo Hospital
OTHER
Responsible Party
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First Service of anesthesia and intensive care. San Gerardo Hospital
Principal Investigators
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Massimo Allegri, MD
Role: STUDY_CHAIR
Servizio Anestesia e Rianimazione I e Terapia del Dolore, Fondazione IRCCS Policlinico San Matteo, Pavia
Mario Regazzi, MD
Role: STUDY_CHAIR
Head of Clinical PK and TDM Laboratory, Foundation IRCCS Policlinico San Matteo, Pavia
Ernesto Pizzirani, MD
Role: STUDY_CHAIR
U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova
Fiorenza Franceschi, MD
Role: STUDY_CHAIR
U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova
Armando Alborghetti, MD
Role: STUDY_CHAIR
U.O.C. Anestesia e Rianimazione. Ospedale di Ponte San Pietro. Bergamo
Alessandro Albani, MD
Role: STUDY_CHAIR
U.O. Anestesia e Rianimazione. Ospedale Regionale "U. Parini", Aosta
Pierre Diemusch, MD
Role: STUDY_CHAIR
Servizio di Anestesia e rianimazione chirurgica. Hospital de Hautepierre. Università di Strasburgo.
Locations
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San Gerardo Hospital
Monza, MB, Italy
Countries
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References
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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.
Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
Other Identifiers
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AR HSG 01 2010
Identifier Type: -
Identifier Source: org_study_id
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