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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)

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03775018
Enrollment
140
Registered
2018-12-13
Start date
2018-12-13
Completion date
2019-04-30
Last updated
2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

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

Sponsors

Hospital General Universitario Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain24 hours after surgeryPain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm

Contacts

Primary ContactJaime Ruiz-Tovar, MD, PhD
jruiztovar@gmail.com(0034)630534808
Backup ContactManuel Duran, MD, PhD
manuel.duran@hrjc.es(0034)682357456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026