Phase 4 N=21 Randomized Single-blind Treatment

Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT04284930 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Total Narcotic Usage — 0.8; .13; 0.18 mg/kg/day morphine

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Depobupivacaine (Drug); OnQ pump (Drug); 0.25% Bupivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: The Cleveland Clinic
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Narcotic Usage	0.8; .13; 0.18	—

Summary

Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.

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

View full record on ClinicalTrials.gov →

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.