Clinical trial NCT01143025: Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery
Official title: Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laparoscopic Cholecystectomy
Keywords: Laparoscopic Cholecystectomy
Nebulization
Ropivacaine
Lead sponsor: San Gerardo Hospital
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Azienda L'ULSS 15 Alta Padovana
name: Gruppo Ospedaliero San Donato, Policlinico San Pietro, Ponte San Pietro, Bergamo
name: Azienda U.S.L. della Valle d'Aosta, Ospedale Regionale Umberto Parini
First posted: 2010-06-14
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption (mg)
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine
timeFrame: Up to 360 minutes
measure: Ropivacaine pharmacokinetics profile: Tissue drug analysis
timeFrame: Up to 2 hours
measure: Postoperative Pain
timeFrame: Up to 48 hours
measure: Time of unassisted walking
timeFrame: Up to 48 hours
measure: Hospital morbidity
timeFrame: Up to 48 hours
measure: Time and condition for hospital discharge
timeFrame: Up to 48 hours
measure: Quality of life after surgery
timeFrame: Four weeks after surgery
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
state: MB
Study officials:
affiliation: Servizio Anestesia e Rianimazione I e Terapia del Dolore, Fondazione IRCCS Policlinico San Matteo, Pavia
name: Massimo Allegri, MD
role: STUDY_CHAIR
affiliation: Head of Clinical PK and TDM Laboratory, Foundation IRCCS Policlinico San Matteo, Pavia
name: Mario Regazzi, MD
role: STUDY_CHAIR
affiliation: U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova
name: Ernesto Pizzirani, MD
role: STUDY_CHAIR
affiliation: U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova
name: Fiorenza Franceschi, MD
role: STUDY_CHAIR
affiliation: U.O.C. Anestesia e Rianimazione. Ospedale di Ponte San Pietro. Bergamo
name: Armando Alborghetti, MD
role: STUDY_CHAIR
affiliation: U.O. Anestesia e Rianimazione. Ospedale Regionale "U. Parini", Aosta
name: Alessandro Albani, MD
role: STUDY_CHAIR
affiliation: Servizio di Anestesia e rianimazione chirurgica. Hospital de Hautepierre. Università di Strasburgo.
name: Pierre Diemusch, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.