TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass
Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)
1 other identifier
interventional
140
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2018
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2018
CompletedFirst Posted
Study publicly available on registry
December 13, 2018
CompletedStudy Start
First participant enrolled
December 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedDecember 13, 2018
December 1, 2018
5 months
December 12, 2018
December 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm
24 hours after surgery
Study Arms (2)
Transversus abdominis plain blockade
EXPERIMENTALThe patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
Intravenous analgesia
ACTIVE COMPARATORThe patients will receive intravenous analgesia with Acetaminophen (1g/6h)
Interventions
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.
Acetaminophen 1g/6h iv will be administered
Eligibility Criteria
You may qualify if:
- Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Damian Garcia, MD, PhD
Hospital Rey Juan Carlos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The analgesic treatment applied will be blinded to the treatment and to the epidemiology nurse who will assess the postoperative pain
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Surgery
Study Record Dates
First Submitted
December 12, 2018
First Posted
December 13, 2018
Study Start
December 13, 2018
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
December 13, 2018
Record last verified: 2018-12