Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

NCT ID: NCT03203070

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patient and nursery staff evaluating postoperative pain do not know the applied intervention.

Study Groups

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Metamizol iv

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

Group Type ACTIVE_COMPARATOR

Metamizol iv

Intervention Type DRUG

Postoperative analgesia iv with Metamizol 2g/8h will be administered.

TAP block

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

Group Type EXPERIMENTAL

Metamizol iv

Intervention Type DRUG

Postoperative analgesia iv with Metamizol 2g/8h will be administered.

TAP block

Intervention Type PROCEDURE

Intraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5%

Interventions

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Metamizol iv

Postoperative analgesia iv with Metamizol 2g/8h will be administered.

Intervention Type DRUG

TAP block

Intraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5%

Intervention Type PROCEDURE

Other Intervention Names

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Nolotil Transversus abdominis plane block

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Head of Department of Research in Bariatric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manule Duran

Role: STUDY_DIRECTOR

Hospital Universitario Rey Juan Carlos

Locations

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General Hospital Elche

Elche, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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JAIME RUIZ TOVAR

Role: CONTACT

Phone: 630534808

Email: [email protected]

Manuel Duran

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jaime Ruiz-Tovar

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29980989 (View on PubMed)

Other Identifiers

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HRJC/2017/17

Identifier Type: -

Identifier Source: org_study_id