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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Anesthetics; Anesthetics, Local; Bupivacaine

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