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

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Depobupivacaine
* Drug: OnQ pump
* Drug: 0.25% Bupivacaine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depobupivacaine<br>Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. | Drug: Depobupivacaine<br>* surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.<br>* Other names: Exparel;|
| Active Comparator: OnQ Pump<br>Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. | Drug: OnQ pump<br>* group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.<br>|
| Active Comparator: bupivacaine<br>Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. | Drug: 0.25% Bupivacaine<br>* group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.<br>* Other names: Marcaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Narcotic Usage | Post-op pain measured by total post-op Morphine equivalents | total hospital stay, an average of 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
local anesthetic continuous infusion pump, local injection of Exparel