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| Name | Class |
|---|---|
| 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 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine 50 mg | Active Comparator | Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity |
|
| Ropivacaine 100 mg | Experimental | Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity |
|
| Ropivacaine 150 mg | Experimental | Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 50 mg | Drug | Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine | We will perform a pharmacokinetic analysis through venous samples collected at 20, 40, 60, 90, 240, and 360 minutes after the end of nebulization. | Up to 360 minutes |
| Ropivacaine pharmacokinetics profile: Tissue drug analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Gerardo Hospital | Monza | MB | 20052 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18633034 | Background | 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. | |
| 18347861 | Background | 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. |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| UNKNOWN |
| Azienda U.S.L. della Valle d'Aosta, Ospedale Regionale Umberto Parini | UNKNOWN |
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| Ropivacaine 100 mg | Drug | Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity |
|
|
| Ropivacaine 150 mg | Drug | Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity |
|
|
Tissue samples (at least 2 g of tissue) from parietal peritoneum will be taken at the end of surgery . The supernatant will be analised with mass-spectrometry |
| Up to 2 hours |
| Postoperative Pain | Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). Pain after surgery will be differentiated as abdominal, wall pain, port wound pain and/or shoulder pain. The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed. | Up to 48 hours |
| Time of unassisted walking | Unassisted walking time is defined as the time in hours between PACU discharge and when the patient is able to walk out of his room and back to bed without any assistance. | Up to 48 hours |
| Hospital morbidity | All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified using the anesthesia charts, surgical charts, surgical database. | Up to 48 hours |
| Time and condition for hospital discharge | We define hospital stay as the elapsed time between surgery and hospital discharge, in days. We also evaluate the hospital stay with the post-anesthetic discharge scoring system (Modified-PADSS). | Up to 48 hours |
| Quality of life after surgery | Quality of life will be assessed using the SF-36 questionnaire | Four weeks after surgery |
| 17180268 | Result | 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. |
| D000588 |
| Amines |