Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Metamizol iv; Procedure: TAP block

Study type: Interventional

Funder types: Other

Identifiers

NCT03203070

HRJC/2017/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Metamizol iv

Active Comparator group

Description:

The patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain.

Treatment:

Drug: Metamizol iv

TAP block

Experimental group

Description:

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

Treatment:

Procedure: TAP block

Drug: Metamizol iv