Phase 3
N=120
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
Breast - Female
Bottom Line
View on ClinicalTrials.gov: NCT02601027 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Post-operative Narcotic Usage — 139.3; 169.2 milligrams (mg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Transversus Abdominis Plane (TAP) block (Procedure); Nimbus Infusion Pump IV Administration (Device); Bupivacaine infusion (Drug); Acetominophen (Drug); Hydromorphone (Drug); Oxycodone (Drug); Ondansetron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Narcotic Usage |
139.3; 169.2 | — |
| SECONDARY Post-operative Pain Score |
3.76; 3.96 | — |
| SECONDARY Post-operative Anti-emetic Usage |
5.14; 9.93 | — |
| SECONDARY Time to Ambulation |
1.28; 1.45 | — |
| SECONDARY Time to First Bowel Movement |
1.67; 1.62 | — |
| SECONDARY Quality of Life Measurement |
97.30; 99.08; 342.11; 358.00 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Prior diagnosis or presumed diagnosis of breast cancer or undergoing prophylactic treatment.
- Greater than 18 years old.
- Female.
- Undergoing microsurgical breast reconstruction with abdominal free flap.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- True allergy to local anesthetics or opioids.
- History of addiction to narcotics within the last 24 months
- History of chronic pain on opioids within the last 24 months.
- Specific mental health issues such as schizophrenia or bipolar disorder.
- Patients who are pregnant.
Data sourced from ClinicalTrials.gov (NCT02601027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.