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

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: 0.25% Bupivacaine; Drug: Depobupivacaine; Drug: OnQ pump

Study type: Interventional

Funder types: Other

Identifiers

NCT04284930

15-1535

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups

Depobupivacaine

Experimental group

Description:

Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.

Treatment:

Drug: Depobupivacaine

OnQ Pump

Active Comparator group

Description:

Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.

Treatment:

Drug: OnQ pump

bupivacaine

Active Comparator group

Description:

Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.

Treatment:

Drug: 0.25% Bupivacaine