TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

December 12, 2018 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)

Patients will be randomized into 2 groups:

  • TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia
  • IV: Patients receiving only intravenous Acetaminophen analgesia

Postoperative pain 24 hours after surgery will be evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized into 2 groups:

  • TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h)
  • IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)

Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.

Study Type

Interventional

Enrollment (Anticipated)

140

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.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure

Exclusion Criteria:

  • Patients undergoing OAGB as revisional procedure
  • Patients undergoing other bariatric procedures
  • Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)
  • Patients with history of allegy to local anesthetic drugs

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transversus abdominis plain blockade
The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
Procedure: Transversus abdominis plane blockade
Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.
Drug: Intravenous analgesia
Acetaminophen 1g/6h iv will be administered
Active Comparator: Intravenous analgesia
The patients will receive intravenous analgesia with Acetaminophen (1g/6h)
Drug: Intravenous analgesia
Acetaminophen 1g/6h iv will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 24 hours after surgery
Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm
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: Damian Garcia, MD, PhD, Hospital Rey Juan Carlos

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 (Anticipated)

December 13, 2018

Primary Completion (Anticipated)

April 30, 2019

Study Completion (Anticipated)

April 30, 2019

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

December 12, 2018

First Posted (Actual)

December 13, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRJC 18-14

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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