Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

Phase 3

• Conditions: Pain, Postoperative
• Interventions: Drug: Metamizol iv; Procedure: TAP block

• Registration Number: NCT03203070
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-25
• Study First Submitted QC: 2017-06-28
• Last Update Submitted: 2017-06-28
• Study First Posted: 2017-06-29
• Last Update Posted: 2017-06-29
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metamizol iv	Metamizol iv	The patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain.
TAP block	TAP block	The patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain.
TAP block	Metamizol iv	The patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours after surgery	Pain quantification will be assessed with a Visual Analogic Scale

Trial Locations

Locations (1)

General Hospital Elche; 🇪🇸 Elche, Alicante, Spain