Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

Study Overview
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Brief Summary
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A prospective randomized trial will be performed. Patients undergoing gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia, and patients receiving only postoperative intravenous analgesia (Group 2). Postoperative pain will be assessed with a Visual Analogic Scale 24h after surgery and morphine needs will be quantified.

Detailed Description
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A prospective randomized trial will be performed. Patients undergoing laparoscopic Roux-en-Y gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided TAP block with 30 ml Bupivacaine 0.5%, as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h), and patients receiving only postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h) (Group 2). Postoperative pain will be assessed with a Visual Analogic Scale 24 hours after surgery and morphine needs will be quantified.

Official Title
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Laparoscopic-guided Transversus Abdominis Plane (TAP) Block for Postoperative Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Metamizol iv
* Procedure: TAP block


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 and obesity associated comorbidities Patients undergoing laparoscopic Roux en Y gastric bypass Exclusion Criteria: Patients undergoing other bariatric procedures, different than Roux en Y gastric bypass Patients undergoing open 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metamizol iv<br>The patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain. | Drug: Metamizol iv<br>* Postoperative analgesia iv with Metamizol 2g/8h will be administered.<br>* Other names: Nolotil;|
| Experimental: TAP block<br>The patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain. | Drug: Metamizol iv<br>* Postoperative analgesia iv with Metamizol 2g/8h will be administered.<br>* Other names: Nolotil;Procedure: TAP block<br>* Intraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5%<br>* Other names: Transversus abdominis plane block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Pain quantification will be assessed with a Visual Analogic Scale | 24 hours after surgery |