Phase 4
Completed N=21
Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
Pain, Postoperative
Source: ClinicalTrials.gov NCT04284930 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Total Narcotic Usage — 0.8; .13; 0.18 mg/kg/day morphine
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Narcotic Usage |
0.8; .13; 0.18 | — |
Eligibility Criteria
Inclusion Criteria
- Non pregnant women
- age 18 years or older
- scheduled to have unilateral DIEP flap breast reconstruction.
- Must have ASA physical status classification of 1,2, or 3
Exclusion Criteria
- concurrent or recent medical condition that could interfere with study participation
- history of any of the following:
- hepatitis
- alcohol/substance abuse
- uncontrolled psychiatric disorders
- known allergy/ contraindication to any of the following:
- amide-type local anesthetics
- opioids
- propofol
- Body weight of less than 50 kg
- have participated in another study involving an investigational medication with in the past 30 days
- taking analgesics, antidepressants, or glucocorticoids within the 3 days before surgery
Data sourced from ClinicalTrials.gov (NCT04284930). 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. Informational only — not medical advice.