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TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

NCT ID: NCT03775018

Last Updated: 2018-12-13

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-13

Study Completion Date

2019-04-30

Brief Summary

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Patients will be randomized into 2 groups:

* TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia
* IV: Patients receiving only intravenous Acetaminophen analgesia

Postoperative pain 24 hours after surgery will be evaluated.

Detailed Description

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Patients will be randomized into 2 groups:

* TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h)
* IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)

Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The analgesic treatment applied will be blinded to the treatment and to the epidemiology nurse who will assess the postoperative pain

Study Groups

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Transversus abdominis plain blockade

The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia

Group Type EXPERIMENTAL

Transversus abdominis plane blockade

Intervention Type PROCEDURE

Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.

Intravenous analgesia

Intervention Type DRUG

Acetaminophen 1g/6h iv will be administered

Intravenous analgesia

The patients will receive intravenous analgesia with Acetaminophen (1g/6h)

Group Type ACTIVE_COMPARATOR

Intravenous analgesia

Intervention Type DRUG

Acetaminophen 1g/6h iv will be administered

Interventions

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Transversus abdominis plane blockade

Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.

Intervention Type PROCEDURE

Intravenous analgesia

Acetaminophen 1g/6h iv will be administered

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure

Exclusion Criteria

* Patients undergoing OAGB as revisional procedure
* Patients undergoing other bariatric procedures
* Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)
* Patients with history of allegy to local anesthetic drugs
Minimum Eligible Age

18 Years

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

Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Damian Garcia, MD, PhD

Role: STUDY_DIRECTOR

Hospital Rey Juan Carlos

Central Contacts

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Jaime Ruiz-Tovar, MD, PhD

Role: CONTACT

Phone: (0034)630534808

Email: [email protected]

Manuel Duran, MD, PhD

Role: CONTACT

Phone: (0034)682357456

Email: [email protected]

Other Identifiers

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HRJC 18-14

Identifier Type: -

Identifier Source: org_study_id