NCT03203070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 25, 2017

Last Update Submit

June 28, 2017

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Pain quantification will be assessed with a Visual Analogic Scale

    24 hours after surgery

Study Arms (2)

Metamizol iv

ACTIVE COMPARATOR

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

Drug: Metamizol iv

TAP block

EXPERIMENTAL

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

Drug: Metamizol ivProcedure: TAP block

Interventions

Metamizol ivDRUG

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

Also known as: Nolotil
Metamizol ivTAP block
TAP blockPROCEDURE

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

Also known as: Transversus abdominis plane block
TAP block

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) \>40 Kg/m2
  • BMI \>35 Kg/m2 and obesity associated comorbidities
  • Patients undergoing laparoscopic Roux en Y gastric bypass

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Elche

Elche, Alicante, 03203, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29980989DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

metamizole magnesium

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Manule Duran

    Hospital Universitario Rey Juan Carlos

    STUDY DIRECTOR

Central Study Contacts

JAIME RUIZ TOVAR

CONTACT

630534808jruiztovar@gmail.com

Manuel Duran

CONTACT

manuel.dpv@hrjc.es

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patient and nursery staff evaluating postoperative pain do not know the applied intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Research in Bariatric Surgery

Study Record Dates

First Submitted

June 25, 2017

First Posted

June 29, 2017

Study Start

March 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

June 29, 2017

Record last verified: 2017-06

Locations

ES(1)