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TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

H

Hospital General Universitario Elche

Status and phase

Unknown
Phase 3

Conditions

Pain, Postoperative

Treatments

Drug: Intravenous analgesia
Procedure: Transversus abdominis plane blockade

Study type

Interventional

Funder types

Other

Identifiers

NCT03775018
HRJC 18-14

Details and patient eligibility

About

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.

Full description

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.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

Transversus abdominis plain blockade
Experimental group
Description:
The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
Treatment:
Drug: Intravenous analgesia
Procedure: Transversus abdominis plane blockade
Intravenous analgesia
Active Comparator group
Description:
The patients will receive intravenous analgesia with Acetaminophen (1g/6h)
Treatment:
Drug: Intravenous analgesia

Trial contacts and locations

0

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Central trial contact

Manuel Duran, MD, PhD; Jaime Ruiz-Tovar, MD, PhD

Data sourced from clinicaltrials.gov

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