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Liposomal Bupivacaine in Implant Based Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT02659501
Recruitment Status : Terminated
First Posted : January 20, 2016
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Subhas Gupta, MD, PhD, Loma Linda University

Brief Summary:

Objectives:

  1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
  2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
  3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.
  4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
  5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.

Condition or disease Intervention/treatment Phase
Breast Cancer Postoperative Pain Drug: Liposomal bupivacaine Drug: Bupivacaine with epinephrine Drug: Morphine sulfate Drug: Hydrocodone/acetaminophen Drug: Diazepam Not Applicable

Detailed Description:

Objectives:

  1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
  2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
  3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.
  4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
  5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.

The objective of this project is to evaluate the role of liposomal bupivacaine in postoperative pain control following tissue expander and implant based breast reconstruction. This unique formulation of bupivacaine lends this drug a longer duration of action and reduced plasma bupivacaine concentrations compared to plain bupivacaine. This agent has been demonstrated to be safe, well tolerated, and effective in a number of different clinical applications. However, its role has yet to be evaluated in the context of breast reconstruction.

Thus, the authors propose the first, randomized, controlled clinical trial of liposomal bupivacaine for postoperative pain management following tissue expander and implant based breast reconstruction. Patients will be stratified into two study groups. Patients in the Group 1 (Bupivacaine) will be treated intraoperatively with injections of 0.5% bupivacaine and epinephrine 1:200,000, with 50 mg delivered to perform a field block of each pocket. This is the current standard of care. Patients in the Group 2 (Liposomal Bupivacaine) will be treated intraoperatively with injections of 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. This is the experimental intervention. Postoperatively, the investigators will assess pain levels, opioid consumption, opioid related adverse events, length of stay, and satisfaction.

The findings from this study will allow the authors to better elucidate the role of liposomal bupivacaine in expander/implant based breast reconstruction. In doing so, they may allow the authors to identify the ideal pain regimen for these patients. This holds important implications, with the potential to reduce postoperative pain, opioid consumption, opioid related adverse events, length of stay, and patient satisfaction.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine in Implant Based Breast Reconstruction
Actual Study Start Date : July 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bupivacaine with epinephrine injections
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Drug: Bupivacaine with epinephrine
Bupivacaine, like other local anesthetics reduces the flow of sodium in and out of nerves. This decreases the initiation and transfer of nerve signals in the area in which the drug is injected. This leads first to a loss of sensation of pain, temperature, touch, and deep pressure. This drug is the current standard of care for local, postoperative local anesthesia following breast reconstruction. Epinephrine, a vasoconstrictor, is included in bupivacaine formulations to improve the duration of local anesthesia.
Other Names:
  • Marcaine
  • Sensorcaine

Drug: Morphine sulfate
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
Other Name: Roxanol

Drug: Hydrocodone/acetaminophen
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Other Name: Norco

Drug: Diazepam
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
Other Name: Valium

Experimental: Liposomal bupivacaine
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Drug: Liposomal bupivacaine
Liposomal Bupivacaine is an aqueous suspension of multivesicular liposomes containing bupivacaine. After injection into soft tissue, bupivacaine is slowly released from the multivesicular liposomes, extending this drug's duration of action.
Other Name: Exparel

Drug: Morphine sulfate
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
Other Name: Roxanol

Drug: Hydrocodone/acetaminophen
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Other Name: Norco

Drug: Diazepam
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
Other Name: Valium




Primary Outcome Measures :
  1. The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1. [ Time Frame: Average Pain Scores 24 hours Post-Operatively ]
    Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.

  2. The Effect of Liposomal Bupivacaine on Antiemetic Consumption [ Time Frame: 24 hours ]
    The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively.

  3. The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption [ Time Frame: 24 hours ]
    Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour.

  4. The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption [ Time Frame: 24 hours ]
    Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively.

  5. The Effect of Liposomal Bupivacaine on Length of Hospital Stay [ Time Frame: 24-60 hours ]
    Length of hospital stay will be determined for patients in each group, in total hours.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing immediate unilateral or bilateral tissue-expander breast reconstruction following skin-sparing or nipple-sparing mastectomy

Exclusion Criteria:

  • Women who are unable to give informed consent to participate in this study
  • Women with a documented history of hypersensitivity reactions to local-anesthetic agents
  • Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
  • Women who are currently pregnant
  • Women undergoing tissue expander based breast reconstruction with a muscle flap in combination with a tissue expander
  • Women with impaired hepatic function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659501


Locations
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United States, California
Loma Linda University Health System
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Subhas C. Gupta, MD, PhD Loma Linda University
Study Director: Wendy W. Wong, MD Loma Linda University

Publications:

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Responsible Party: Subhas Gupta, MD, PhD, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT02659501     History of Changes
Other Study ID Numbers: 5150012
First Posted: January 20, 2016    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Subhas Gupta, MD, PhD, Loma Linda University:
Breast reconstruction
Bupivacaine
Liposomal bupivacaine
Postoperative analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Epinephrine
Racepinephrine
Diazepam
Morphine
Hydrocodone
Oxycodone
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents