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Post-Mastectomy Analgesia Using Exparel (Liposomal) Versus Standard Bupivacaine or Placebo

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ClinicalTrials.gov Identifier: NCT03504865
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Brief Summary:

This is a randomized, single-blinded placebo-controlled trial.

Patients will be randomized to one of three arms: (1) injection of liposomal bupivacaine at the end of the operation, (2) injection of standard bupivacaine at the end of the operation, or (3) no injection of local anesthetic. All patients will be able to receive IV and oral narcotic medications in the postoperative period on an as-needed basis.

If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with various amounts of normal saline to cover the appropriate surgical field. Our routine expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In our practice,we use an 18-gauge needle to inject the medication in a "field-effect" encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by injecting around the edges of the skin incision and drain site. This occurs prior to dissection of the pectoralis muscle and implant or tissue expander placement.

Patients randomized to the SB arm will receive weight-based dosing of bupivacaine, administered in the same manner as the LB arm.

Patients who are in the placebo arm will have a similar volume of saline injected into the operative site.

Postoperatively, all patients will be kept in the hospital for at least one night. Total length of stay will be documented. They will all have the option of receiving IV morphine injections as well as oral acetaminophen-hydrocodone as needed for additional pain control. The administration of these additional medications will be recorded for each patient.

On postoperative day 1, each patient will be administered the American Pain Society Outcome Questionnaire while in the hospital. After discharge from the hospital, we will call the patient on postoperative day 2, 3, 5 and 7 to assess pain and satisfaction scores, using the same questions each time. For any patients staying in the hospital longer than 1 day, the questionnaire will be administered in the hospital on the same postoperative days. Subject participation only lasts for these 7 days of follow up.


Condition or disease Intervention/treatment Phase
Mastectomy Breast Cancer Drug: Liposomal bupivacaine Drug: Standard bupivacaine Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-Blinded, Randomized Assessment of Post-Mastectomy Analgesia Using Exparel (Liposomal) Versus Standard Bupivacaine or Placebo
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Liposomal bupivacaine
If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with various amounts of normal saline to cover the appropriate surgical field. Our routine expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In our practice,we use an 18-gauge needle to inject the medication in a "field-effect" encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by injecting around the edges of the skin incision and drain site. This occurs prior to dissection of the pectoralis muscle and implant or tissue expander placement.
Drug: Liposomal bupivacaine
Given at the end of the operation.
Other Name: Exparel

Active Comparator: Standard bupivacaine
Patients randomized to the SB arm will receive weight-based dosing of bupivacaine, administered in the same manner as the LB arm.
Drug: Standard bupivacaine
Given at the end of the operation.

Placebo Comparator: Placebo
Patients who are in the placebo arm will have a similar volume of saline injected into the operative site.
Other: Placebo
Saline will be administered as the placebo and will be given at the end of the operation.




Primary Outcome Measures :
  1. Postop pain and satisfaction scores [ Time Frame: 1 week ]
    Using a validated questionnaire - the American Pain Society Outcome Questionnaire

  2. The Number of adverse events [ Time Frame: 1 week ]
    As measured by number by the CTCAE v4.03


Secondary Outcome Measures :
  1. Overall narcotic use [ Time Frame: 1 week ]
    The amount of narcotics required per patient

  2. Time in recovery [ Time Frame: 1 week ]
    Measured as the number of hours from surgery to recovery

  3. Time from recovery to discharge [ Time Frame: 1 week ]
    Measured as the number of days and hours that a patient is admitted to the hospital



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. All female patients over 18
  2. Subjects must be scheduled to undergo bilateral therapeutic or prophylactic skin or nipple-sparing mastectomy at Medstar Georgetown University Hospital
  3. Subjects must have immediate reconstruction consisting of either tissue expander placement or direct implant placement at the time of mastectomy
  4. subjects are capable of giving informed consent

Exclusion Criteria:

  1. Subjects cannot be homeless persons
  2. Subjects cannot have active drug/alcohol dependence or abuse history.
  3. Subjects cannot be pregnant
  4. Subjects cannot have documented chronic or recent opioid use as well as chronic pain syndromes
  5. We will exclude any patients who will plan to undergo postoperative whole breast radiation
  6. Subjects cannot have bupivacaine (and all related analog) allergies

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): NCT03504865


Contacts
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Contact: Eleni Tousimis, MD 202-444-8595 eleni.a.tousimis@gunet.georgetown.edu

Locations
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United States, District of Columbia
MedStar Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Eleni Tousimis, MD         
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Eleni Tousimis, MD MedStar Georgetown University Hospital

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT03504865     History of Changes
Other Study ID Numbers: 2018-0175
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Georgetown University:
Exparel
Bupivacaine

Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents