Back to resultsTAP Blockade for Pain Control in One-Anastomosis Gastric Bypass
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Transversus abdominis plane blockade
Intravenous analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transversus abdominis plain blockade
Intravenous analgesia
Arm Description
The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
The patients will receive intravenous analgesia with Acetaminophen (1g/6h)
Outcomes
Primary Outcome Measures
Postoperative pain
Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm
Secondary Outcome Measures
Full Information
NCT ID
NCT03775018
First Posted
December 12, 2018
Last Updated
December 12, 2018
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT03775018
Brief Title
TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass
Official Title
Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2018 (Anticipated)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The analgesic treatment applied will be blinded to the treatment and to the epidemiology nurse who will assess the postoperative pain
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transversus abdominis plain blockade
Arm Type
Experimental
Arm Description
The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
Arm Title
Intravenous analgesia
Arm Type
Active Comparator
Arm Description
The patients will receive intravenous analgesia with Acetaminophen (1g/6h)
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane blockade
Intervention Description
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
Drug
Intervention Name(s)
Intravenous analgesia
Intervention Description
Acetaminophen 1g/6h iv will be administered
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Ruiz-Tovar, MD, PhD
Phone
(0034)630534808
Email
jruiztovar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Duran, MD, PhD
Phone
(0034)682357456
Email
manuel.duran@hrjc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian Garcia, MD, PhD
Organizational Affiliation
Hospital Rey Juan Carlos
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass
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