NCT01568437 is a Phase 3 clinical trial of TAP-Block in Gastric-bypass Surgery, sponsored by University Health Network, Toronto.

Who is sponsoring NCT01568437?

NCT01568437 is sponsored by University Health Network, Toronto.

What drugs are being tested in NCT01568437?

Interventions in NCT01568437: TAP-Block, Conventional Managment.

What condition does NCT01568437 study?

NCT01568437 studies Gastric-bypass Surgery, Opioid Consumption, Obesity.

Is NCT01568437 still recruiting?

NCT01568437 is currently completed. Last updated 7 December 2015.

Last reviewed 2015-12-07 · How we verify

NCT01568437

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Is the Analgesic Effect of the Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery Useful?

Completed Phase 3 Last updated 7 December 2015

What this trial tests

Phase 3 trial testing TAP-Block in Gastric-bypass Surgery in 70 participants. Completed in 1 March 2013.

Timeline

1 January 2012

Primary endpoint
1 January 2013

1 March 2013

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	1 January 2012
Primary completion	1 January 2013
Estimated completion	1 March 2013
Sites	1 location across Canada

Drugs / interventions tested

TAP-Block
Conventional Managment

Conditions studied

Gastric-bypass Surgery — all drugs for Gastric-bypass Surgery →
Opioid Consumption — all drugs for Opioid Consumption →
Obesity — all drugs for Obesity →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 70, any sex, with Gastric-bypass Surgery or Opioid Consumption. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Opioid consumption over the first 24 hours following LGBS.
Time frame: 24 hrs
Opioid consumption will be expressed in terms of milligrams doses of PO morphine. If other opioids are used, doses will be converted to the equivalent PO morphine dose using standard opioid dosage conversion tables.

Sponsor's own description

Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid obesity, which is performed under general anesthesia. TAP block is an analgesic strategy covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are located. As far as the investigators know, this analgesic technique has never been studied in LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP block provides improved analgesia during the first 24 hours after laparoscopic gastric-bypass surgery, compared to conventional therapy only.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01568437 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Health Network, Toronto
Last refreshed: 7 December 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01568437.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing