Laparoscopic Assisted Transversus Abdominis Plane (TAP) Block Vs Local Anesthetic Infiltrations in Bariatric Surgery: a Prospective Randomized Double-Blind Controlled Trial (TAP BLOCK BARIATRIC TRIAL)

Fabio Garofalo1 site in 1 country115 target enrollmentJune 15, 2020

ConditionsPain, Postoperative Bariatric Surgery Candidate

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pain, Postoperative
Sponsor: Fabio Garofalo
Enrollment: 115
Locations: 1
Primary Endpoint: Postoperative Pain
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (Ropivacaine) through two different techniques.

Registry

clinicaltrials.gov

Start Date

June 15, 2020

End Date

July 7, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fabio Garofalo

Responsible Party

Sponsor Investigator

Principal Investigator

Fabio Garofalo

Principal Investigator

Ente Ospedaliero Cantonale, Bellinzona

Eligibility Criteria

Inclusion Criteria

•patients undergoing elective bariatric surgery
•age ≥ 18 years
•signed informed consent

Exclusion Criteria

•Pregnant or lactating women,
•known allergy to local anesthetics
•Chronic pain syndrome.

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: at 24 hours post surgery

Postoperative pain on the visual analogue scale (VAS) This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.

Secondary Outcomes

in hospital satisfaction(during hospitalization,approximately 4 days)
postoperative pain(at 3, 6, 12, 18 hours from surgery)
Number of participants with complications(from surgery up to six weeks after surgery)
lenght of hospital stay(during hospitalization,approximately 4 days)
Number of Participants With Ropivacaine-Related Adverse Events(from surgery up to six weeks after surgery)