Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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 300mg in 200 ml(Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline 200ml (Control Group - CG).

Official Title
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Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery

Conditions
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Pain

Intervention / Treatment
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* Drug: Ropivacaine irrigation
* Drug: Normal saline irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) >40 Kg/m2 BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity. Exclusion Criteria: patients undergoing other bariatric techniques or revisional surgery allergy to local anesthetics severe underlying cardiovascular diseases chronic renal failure hepatic dysfunction previous foregut surgery patients with any contraindication for bariatric surgery.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine irrigation<br>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. | Drug: Ropivacaine irrigation<br>* 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.<br>* Other names: Intraperitoneal Ropivacaine irrigation;|
| Placebo Comparator: Normal saline irrigation<br>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. | Drug: Normal saline irrigation<br>* 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.<br>* Other names: Intraperitoneal Normal saline irrigation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |