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