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

NCT ID: NCT04284930

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-11-30

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Depobupivacaine

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

Group Type: EXPERIMENTAL

Depobupivacaine

Intervention Type: DRUG

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.

OnQ Pump

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

Group Type: ACTIVE_COMPARATOR

OnQ pump

Intervention Type: DRUG

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.

bupivacaine

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

Group Type: ACTIVE_COMPARATOR

0.25% Bupivacaine

Intervention Type: DRUG

group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.

Interventions

Depobupivacaine

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.

Intervention Type: DRUG

OnQ pump

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.

Intervention Type: DRUG

0.25% Bupivacaine

group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.

Intervention Type: DRUG

Other Intervention Names

Exparel; Marcaine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Risal Djohan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Risal Djohan, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-1535

Identifier Type: -

Identifier Source: org_study_id