Who is sponsoring NCT02601027?

NCT02601027 is sponsored by Stanford University.

What drugs are being tested in NCT02601027?

Interventions in NCT02601027: Transversus Abdominis Plane (TAP) block, Nimbus Infusion Pump IV Administration, Bupivacaine infusion, Acetominophen, Hydromorphone, Oxycodone, Ondansetron.

What condition does NCT02601027 study?

NCT02601027 studies Breast - Female.

Is NCT02601027 still recruiting?

NCT02601027 is currently completed. Last updated 28 August 2021.

Are results published for NCT02601027?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-08-28 · How we verify

NCT02601027

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

A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction

Completed Phase 3 Results posted Last updated 28 August 2021

What this trial tests

Phase 3 trial testing Transversus Abdominis Plane (TAP) block in Breast - Female in 120 participants. Completed in 1 June 2021.

Timeline

1 November 2015

Primary endpoint
7 September 2019

1 June 2021

Quick facts

Lead sponsor	Stanford University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	120
Start date	1 November 2015
Primary completion	7 September 2019
Estimated completion	1 June 2021
Sites	1 location across United States

Drugs / interventions tested

Transversus Abdominis Plane (TAP) block — full drug profile →
Nimbus Infusion Pump IV Administration
Bupivacaine infusion — full drug profile →
Acetominophen — full drug profile →
Hydromorphone (HYDROMORPHONE) — full drug profile →
Oxycodone (oxycodone) — full drug profile →
Ondansetron

Conditions studied

Breast - Female — all drugs for Breast - Female →

Sponsor

Stanford University

Who can join

18 and older, female only, with Breast - Female. 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.

Post-operative Narcotic Usage
Time frame: 48 hours
Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane

Sponsor's own description

The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP block, after breast reconstruction surgery.

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:

Other trials of Transversus Abdominis Plane (TAP) block

Trials testing the same drug.

NCT04427059 — A Study to Compare Two Techniques for Pain Control After Bariatric Surgery · NA · completed

Other recruiting trials for Breast - Female

Currently open trials in the same condition.

NCT07284030 — Psychoeducation and Well-Being After Breast Cancer · NA · recruiting
NCT07553702 — Dance Intervention in Breast Cancer Treatment · NA · active not recruiting

Other Stanford University trials

Trials by the same sponsor.

NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
NCT04225949 — Patients Understanding of PROM Graphs · NA · withdrawn
NCT06273098 — School-Based Bladder Health Intervention · NA · withdrawn
NCT04652635 — Management of Nailbed Injuries · NA · withdrawn
NCT05443503 — Stanford Spine Keeper - Managing Your Low Back Pain · NA · suspended

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 NCT02601027 (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 Stanford University
Last refreshed: 28 August 2021

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/NCT02601027.

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