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TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

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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

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 13, 2018
Last Update Posted Date December 13, 2018
Estimated Study Start Date  ICMJE December 13, 2018
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass
Official Title  ICMJE Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Transversus abdominis plain blockade
    The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
    Interventions:
    • Procedure: Transversus abdominis plane blockade
    • Drug: Intravenous analgesia
  • Active Comparator: Intravenous analgesia
    The patients will receive intravenous analgesia with Acetaminophen (1g/6h)
    Intervention: Drug: Intravenous analgesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2019
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jaime Ruiz-Tovar, MD, PhD (0034)630534808 jruiztovar@gmail.com
Contact: Manuel Duran, MD, PhD (0034)682357456 manuel.duran@hrjc.es
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03775018
Other Study ID Numbers  ICMJE HRJC 18-14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
Study Sponsor  ICMJE Hospital General Universitario Elche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Damian Garcia, MD, PhD Hospital Rey Juan Carlos
PRS Account Hospital General Universitario Elche
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP