Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery
Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy
1 other identifier
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 19, 2011
May 1, 2010
1.1 years
June 9, 2010
May 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphine consumption (mg)
The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display
Up to 48 hours
Secondary Outcomes (7)
Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine
Up to 360 minutes
Ropivacaine pharmacokinetics profile: Tissue drug analysis
Up to 2 hours
Postoperative Pain
Up to 48 hours
Time of unassisted walking
Up to 48 hours
Hospital morbidity
Up to 48 hours
- +2 more secondary outcomes
Study Arms (3)
Ropivacaine 50 mg
ACTIVE COMPARATORPreoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 100 mg
EXPERIMENTALPreoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
Ropivacaine 150 mg
EXPERIMENTALPreoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Interventions
Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- San Gerardo Hospitallead
- University of Milano Bicoccacollaborator
- Fondazione IRCCS Policlinico San Matteo di Paviacollaborator
- Azienda L'ULSS 15 Alta Padovanacollaborator
- Gruppo Ospedaliero San Donato, Policlinico San Pietro, Ponte San Pietro, Bergamocollaborator
- Azienda U.S.L. della Valle d'Aosta, Ospedale Regionale Umberto Parinicollaborator
Study Sites (1)
San Gerardo Hospital
Monza, MB, 20052, Italy
Related Publications (3)
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.
PMID: 18633034BACKGROUNDSchlotterbeck 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.
PMID: 18347861BACKGROUNDAlkhamesi 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.
PMID: 17180268RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Massimo Allegri, MD
Servizio Anestesia e Rianimazione I e Terapia del Dolore, Fondazione IRCCS Policlinico San Matteo, Pavia
- STUDY CHAIR
Mario Regazzi, MD
Head of Clinical PK and TDM Laboratory, Foundation IRCCS Policlinico San Matteo, Pavia
- STUDY CHAIR
Ernesto Pizzirani, MD
U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova
- STUDY CHAIR
Fiorenza Franceschi, MD
U.O.C. Anestesia e Rianimazione. A.O. U.L.S.S.15 "Alta Padovana", Presidio Camposampiero. Camposampiero - Padova
- STUDY CHAIR
Armando Alborghetti, MD
U.O.C. Anestesia e Rianimazione. Ospedale di Ponte San Pietro. Bergamo
- STUDY CHAIR
Alessandro Albani, MD
U.O. Anestesia e Rianimazione. Ospedale Regionale "U. Parini", Aosta
- STUDY CHAIR
Pierre Diemusch, MD
Servizio di Anestesia e rianimazione chirurgica. Hospital de Hautepierre. Università di Strasburgo.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 9, 2010
First Posted
June 14, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2011
Study Completion
May 1, 2011
Last Updated
May 19, 2011
Record last verified: 2010-05