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

Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Unilateral Deep Inferior Epigastic Perforator Free Flap Reconstruction

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Depobupivacaine; Drug: OnQ pump; Drug: 0.25% Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Depobupivacaine; Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.	Drug: 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.; Other Names: Exparel
Active Comparator: OnQ Pump; 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; 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.
Active Comparator: bupivacaine; Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.	Drug: 0.25% Bupivacaine; group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.; 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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Risal Djohan, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: local anesthetic continuous infusion pump; local injection of Exparel
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 15-1535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO