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Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery

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ClinicalTrials.gov Identifier: NCT03383198
Recruitment Status : Terminated (Early termination due to manufacturer discontinued supplying the product for the study.)
First Posted : December 26, 2017
Results First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Prisma Health-Upstate

Brief Summary:
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate reconstruction.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Liposomal bupivacaine right injection Drug: Liposomal bupivacaine left injection Phase 4

Detailed Description:
This research hopes to determine the duration of patient-reported analgesia provided by ultrasound guided PEC II field block injections. The design of the study randomly assigns the side of injection of the study drugs into each patient. All patients are having bilateral mastectomy with immediate reconstruction. Visual analog pain scores (VAS) will be recorded serially for both sides of the patient's chest in hopes of determining a difference in duration and efficacy of the two drugs. In addition to VAS scores, a subjective, binary question will be our primary outcome: does one side of your chest have more surgical pain than the other? We hope that his question, despite being entirely subjective, overcomes interpatient variability of numerical pain score reporting.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Only anesthesiologist performing injection will be aware of which side is injected with each drug.
Primary Purpose: Treatment
Official Title: Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine Plus Dexamethasone for Mastectomy With Immediate Reconstruction
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Liposomal Bupivacaine Left
Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right
Drug: Liposomal bupivacaine left injection
Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
Other Name: Exparel Left

Active Comparator: Liposomal Bupivacaine Right
Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left
Drug: Liposomal bupivacaine right injection
Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
Other Name: Exparel Right




Primary Outcome Measures :
  1. Subjective Bilateral Pain Comparison [ Time Frame: up to 48 hours ]
    Subjective, binary question "Does one side of your chest have more surgical pain than the other?"


Secondary Outcome Measures :
  1. Duration of Analgesia [ Time Frame: up to 48 hours ]
    Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Bilateral mastectomy
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Scheduled for bilateral mastectomy

Exclusion Criteria:

  • allergy to local anesthetics, prior breast surgery, asymmetric surgical plan

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): NCT03383198


Locations
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United States, South Carolina
Patewood Memorial Hospital
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Prisma Health-Upstate
Investigators
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Principal Investigator: William Hand, MD Prisma Health-Upstate
  Study Documents (Full-Text)

Documents provided by Prisma Health-Upstate:
Informed Consent Form  [PDF] June 19, 2019

Publications:
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Responsible Party: Prisma Health-Upstate
ClinicalTrials.gov Identifier: NCT03383198    
Other Study ID Numbers: Pro00072519
First Posted: December 26, 2017    Key Record Dates
Results First Posted: November 19, 2020
Last Update Posted: November 19, 2020
Last Verified: August 2018
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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents