TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

Phase 3

• Conditions: Pain, Postoperative
• Interventions: Drug: Intravenous analgesia; Procedure: Transversus abdominis plane blockade

• Registration Number: NCT03775018
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Last Update Submitted: 2018-12-12
• Study Start: 2018-12-13
• Study First Posted: 2018-12-13
• Last Update Posted: 2018-12-13
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous analgesia	Intravenous analgesia	The patients will receive intravenous analgesia with Acetaminophen (1g/6h)
Transversus abdominis plain blockade	Intravenous analgesia	The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
Transversus abdominis plain blockade	Transversus abdominis plane blockade	The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours after surgery	Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm