Clinical trial NCT04284930: Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
Official title: Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Unilateral Deep Inferior Epigastic Perforator Free Flap Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: local anesthetic continuous infusion pump
local injection of Exparel
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 standard of care and an effective practice for post surgical pain management, However this method only provides relatively brief analgesia, usually lasting only 12 hours. Other FDA approved delivery systems using an indwelling fusion pump catheter (On-Q pump) are currently being used in our practice and may be used to extend the duration of action of locally administered analgesia by continuously infusing anesthetic into the wound. Alternatively, a depot form of bupivacaine has been FDA approved and currently used to deliver a single dose administered via wound infiltration for prolonged analgesia by allowing for the diffusion of the drug over an extended period of time. Both of these products are used as a standard practice during DIEP free flap reconstructions. However, no studies compare the efficacy of these two methods patients undergong unilateral DIEP flap reconstructions has been done in a prospective, randomized control manner.

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

Primary outcomes:
measure: Total Narcotic Usage
timeFrame: total hospital stay, an average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Risal Djohan, MD
role: PRINCIPAL_INVESTIGATOR
References: