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NCT03203070 Clinical Trial

Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03203070
Other study ID # HRJC/2017/17
Secondary ID
Status Recruiting
Phase Phase 3
First received June 25, 2017
Last updated June 28, 2017
Start date March 1, 2017
Est. completion date September 2017

Study information
Verified date June 2017
Source Hospital General Universitario Elche
Contact JAIME RUIZ TOVAR
Phone 630534808
Email jruiztovar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Metamizol iv
Postoperative analgesia iv with Metamizol 2g/8h will be administered.
Procedure:
• TAP block
Intraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5%

Locations
Country Name City State
Spain General Hospital Elche Elche Alicante

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pain Pain quantification will be assessed with a Visual Analogic Scale 24 hours after surgery
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