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OpenTrials
Completed

NCT Number: NCT04284930

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Depobupivacaine

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.

Other names: Exparel

OnQ pump

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.

0.25% Bupivacaine

Drug

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

Other names: Marcaine

Primary outcomes

  1. Total Narcotic Usage

    Time frame: total hospital stay, an average of 3 days

    Post-op pain measured by total post-op Morphine equivalents

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2020
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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