Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

June 28, 2017 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • General Hospital Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Metamizol iv
The patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain.
Drug: Metamizol iv
Postoperative analgesia iv with Metamizol 2g/8h will be administered.
Other Names:
  • Nolotil
EXPERIMENTAL: TAP block
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
Postoperative analgesia iv with Metamizol 2g/8h will be administered.
Other Names:
  • Nolotil
Procedure: TAP block
Intraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5%
Other Names:
  • Transversus abdominis plane block

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Investigators

  • Study Director: Manule Duran, Hospital Universitario Rey Juan Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

September 1, 2017

Study Registration Dates

First Submitted

June 25, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (ACTUAL)

June 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRJC/2017/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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