TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

Pain, Postoperative Clinical Trial

Official title:

Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03775018
• Other study ID #: HRJC 18-14
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 13, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: December 2018
• Source: Hospital General Universitario Elche
• Contact: Jaime Ruiz-Tovar, MD, PhD
• Phone: (0034)630534808
• Email: jruiztovar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm	24 hours after surgery