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There was insuficient recruitment in two centers
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| Name | Class |
|---|---|
| University of Milano Bicocca | OTHER |
| Azienda Ospedaliera di Lecco | OTHER |
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
| University of Pavia |
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The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg produces better postoperative pain control than Saline nebulization after laparoscopic colectomy.
Recently intraperitoneal nebulization of local anesthetic has been used as an alternative to direct intraperitoneal instillation. Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy significantly reduced postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting and it is associated with rapid mobilization compared with patients receiving direct instillation of Bupivacaine 50 mg or placebo.
In a recent study the investigators found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy and gynecologic laparoscopic surgery reduces postoperative pain and morphine consumption. Patients receiving preoperative nebulization of Ropivacaine presented significantly less postoperative pain (-50% clinical setting) and consumed significant less morphine (-50% and -40% respectively) than patients in control groups during the first 48 hours after surgery.
The effects of peritoneal nebulization of ropivacaine during laparoscopic colectomy on pain control and morphine consumption were not evaluated.
The investigators hypothesize that intraperitoneal nebulization of Ropivacaine may produce better pain control and less morphine consumption than nebulization of saline after laparoscopic colectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine 150 mg | Experimental | Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system |
|
| Saline 15 ml | Placebo Comparator | Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 150 mg | Drug | Nebulization of Ropivacaine 150 mg in the peritoneal cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Numeric Ranking Scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS) in PACU and at 6, 24, 48 and 72 hours after the discharge from PACU. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
| Return to active bowel function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo M Ingelmo, MD | San Gerardo Hospital, MB, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera di Lecco. Presidio "A.Manzoni" | Lecco | LC | 23900 | Italy | ||
| San Gerardo Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17180268 | Background | 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. | |
| 18633034 | Background |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| OTHER |
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| saline 15 ml | Drug | Nebulization of saline 15 ml in the peritoneal cavity |
|
|
The return of bowel function will be assessed using two parameters: time of first flatus and time of first bowel movement.
| 72 hours |
| Hospital morbidity | All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified | 72 hours |
| Time and condition for hospital discharge | Time in days elapsed between surgery and hospital discharge. | 72 hours |
| Analgesic consumption | The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display | 72 hours |
| Monza |
| MB |
| 20052 |
| Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | PV | 27100 | Italy |
| 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |