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A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline (Control Group - CG).
A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation 300mg in 200 ml(Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline 200ml (Control Group - CG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine irrigation | Experimental | Using a standard irrigation device, 300 mg total of ropivacaine in 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces. |
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| Normal saline irrigation | Placebo Comparator | Using a standard irrigation device, 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine irrigation | Drug | Using a standard irrigation device (no specific device is being used), 300 mg total of ropivacaine in 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Postoperative pain will be evaluated by a blinded nurse 24 hours after surgery. Pain will be quantified using a visual analogic scale (VAS), ranging from 0(absence of pain) to 10 (unbearable pain). | 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Gonzalez, MD | Hospital General Elche | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27007272 | Derived | Ruiz-Tovar J, Gonzalez J, Garcia A, Cruz C, Rivas S, Jimenez M, Ferrigni C, Duran M. Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery: a Prospective Randomized Clinical Trial. Obes Surg. 2016 Nov;26(11):2616-2621. doi: 10.1007/s11695-016-2142-z. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Normal saline irrigation | Drug | Using a standard irrigation device (no specific device is being used), 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. |
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