Status:
COMPLETED
Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
Lead Sponsor:
The Cleveland Clinic
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.
Detailed Description
Critical to patient recovery, and can contribute to faster patient mobilization, shorter hospital stays and reduced health care costs. The administration of local anesthetics via wound infiltration is...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04284930
Start Date
February 1 2016
End Date
November 1 2017
Last Update
January 7 2021
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195