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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Depobupivacaine
OnQ pump
0.25% Bupivacaine
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring local anesthetic continuous infusion pump, local injection of Exparel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Depobupivacaine

OnQ Pump

bupivacaine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Total Narcotic Usage
Post-op pain measured by total post-op Morphine equivalents

Secondary Outcome Measures

Full Information

First Posted
August 12, 2016
Last Updated
December 13, 2020
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04284930
Brief Title
Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
local anesthetic continuous infusion pump, local injection of Exparel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depobupivacaine
Arm Type
Experimental
Arm Description
Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.
Arm Title
OnQ Pump
Arm Type
Active Comparator
Arm Description
Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Depobupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
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
Intervention Name(s)
OnQ pump
Intervention Description
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
Intervention Name(s)
0.25% Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
Primary Outcome Measure Information:
Title
Total Narcotic Usage
Description
Post-op pain measured by total post-op Morphine equivalents
Time Frame
total hospital stay, an average of 3 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risal Djohan, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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