At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 enrolled
Drug / intervention
Bupivacaine infusion +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Transversus Abdominis Plane (TAP) block, Nimbus Infusion Pump IV Administration, and 5 other interventions for Breast - Female. Completed, enrolled 120 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast - Female
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedNov 2015
Primary CompletionSep 2019
Study CompletionJun 2021
TodayJul 2026
First PostedNov 10, 2015
Enrollment StartNov 1, 2015
Primary CompletionSep 7, 2019
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.6 years ago
Interventions
Transversus Abdominis Plane (TAP) blockprocedure
Nimbus Infusion Pump IV Administrationdevice
Bupivacaine infusiondrug
Acetominophendrug
Hydromorphonedrug
Oxycodonedrug
Ondansetrondrug