Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT04284930
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 21
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Depobupivacaine Depobupivacaine Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. OnQ Pump OnQ pump Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. bupivacaine 0.25% Bupivacaine Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.
- Primary Outcome Measures
Name Time Method Total Narcotic Usage total hospital stay, an average of 3 days Post-op pain measured by total post-op Morphine equivalents
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States