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Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Metamizol iv
TAP block
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • General Hospital ElcheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Metamizol iv

TAP block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative pain
Pain quantification will be assessed with a Visual Analogic Scale

Secondary Outcome Measures

Full Information

First Posted
June 25, 2017
Last Updated
June 28, 2017
Sponsor
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03203070
Brief Title
Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass
Official Title
Laparoscopic-guided Transversus Abdominis Plane (TAP) Block for Postoperative Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Patient and nursery staff evaluating postoperative pain do not know the applied intervention.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metamizol iv
Arm Type
Active Comparator
Arm Description
The patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain.
Arm Title
TAP block
Arm Type
Experimental
Arm Description
The patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain.
Intervention Type
Drug
Intervention Name(s)
Metamizol iv
Other Intervention Name(s)
Nolotil
Intervention Description
Postoperative analgesia iv with Metamizol 2g/8h will be administered.
Intervention Type
Procedure
Intervention Name(s)
TAP block
Other Intervention Name(s)
Transversus abdominis plane block
Intervention Description
Intraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5%
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Pain quantification will be assessed with a Visual Analogic Scale
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JAIME RUIZ TOVAR
Phone
630534808
Email
jruiztovar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Duran
Email
manuel.dpv@hrjc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manule Duran
Organizational Affiliation
Hospital Universitario Rey Juan Carlos
Official's Role
Study Director
Facility Information:
Facility Name
General Hospital Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar
Phone
(0034)630534808
Email
jruiztovar@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29980989
Citation
Ruiz-Tovar J, Garcia A, Ferrigni C, Gonzalez J, Levano-Linares C, Jimenez-Fuertes M, Llavero C, Duran M. Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block as Part of Multimodal Analgesia in Laparoscopic Roux-en-Y Gastric Bypass Within an Enhanced Recovery After Surgery (ERAS) Program: a Prospective Randomized Clinical Trial. Obes Surg. 2018 Nov;28(11):3374-3379. doi: 10.1007/s11695-018-3376-8.
Results Reference
derived

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Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

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