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TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775018
Recruitment Status : Not yet recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, 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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Transversus abdominis plane blockade Drug: Intravenous analgesia Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The analgesic treatment applied will be blinded to the treatment and to the epidemiology nurse who will assess the postoperative pain
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)
Estimated Study Start Date : December 13, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transversus abdominis plain blockade
The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
Procedure: 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.

Drug: Intravenous analgesia
Acetaminophen 1g/6h iv will be administered

Active Comparator: Intravenous analgesia
The patients will receive intravenous analgesia with Acetaminophen (1g/6h)
Drug: Intravenous analgesia
Acetaminophen 1g/6h iv will be administered




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours after surgery ]
    Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775018


Contacts
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Contact: Jaime Ruiz-Tovar, MD, PhD (0034)630534808 jruiztovar@gmail.com
Contact: Manuel Duran, MD, PhD (0034)682357456 manuel.duran@hrjc.es

Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Study Director: Damian Garcia, MD, PhD Hospital Rey Juan Carlos
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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT03775018    
Other Study ID Numbers: HRJC 18-14
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations