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Status unknownNCT03203070Updated Jun 29, 2017

Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

A Phase 3 interventional study of Metamizol iv and TAP block in Pain, Postoperative, sponsored by Hospital General Universitario Elche. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2017-06-29.

Sponsored by Hospital General Universitario Elche · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2017, registered Jun 2017).
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's planned enrollment of 200 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Hospital General Universitario Elche is the lead sponsor of 44 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients undergoing other bariatric procedures, different than Roux en Y gastric bypass
  • Patients undergoing open bariatric surgery
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Metamizol iv

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

    Drug: Metamizol iv

  • 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 · Procedure: TAP block

Interventions

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

    Also known as: Nolotil

  • ProcedureTAP block

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

    Also known as: Transversus abdominis plane block

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What researchers measure

Primary outcomes

  1. Postoperative pain

    Pain quantification will be assessed with a Visual Analogic Scale

    Time frame: 24 hours after surgery

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Study locations

1 of 1 sites recruiting
  • General Hospital Elche
    Elche, Alicante 03203, Spain
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29980989 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03203070
Lead sponsor
Hospital General Universitario Elche
Responsible party
Jaime Ruiz-Tovar, MD, PhD (Head of Department of Research in Bariatric Surgery, Hospital General Universitario Elche) — Principal investigator
First posted
Jun 29, 2017
Start date
Mar 1, 2017
Primary completion
Sep 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Jun 29, 2017

Study contacts

JAIME RUIZ TOVAR
Contact
jruiztovar@gmail.com
630534808
Manuel Duran
Contact
manuel.dpv@hrjc.es
Manule Duran
study director · Hospital Universitario Rey Juan Carlos

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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