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Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass

Laparoscopic-guided Transversus Abdominis Plane (TAP) Block for Postoperative Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03203070
Enrollment
200
Registered
2017-06-29
Start date
2017-03-01
Completion date
2017-09-30
Last updated
2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGMetamizol iv

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

PROCEDURETAP block

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

Sponsors

Hospital General Universitario Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain24 hours after surgeryPain quantification will be assessed with a Visual Analogic Scale

Countries

Spain

Contacts

Primary ContactJAIME RUIZ TOVAR
jruiztovar@gmail.com630534808
Backup ContactManuel Duran
manuel.dpv@hrjc.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026