The Use Of Liposomal Bupivacaine For Pain Control

NCT03722927 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00045562
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.

Conditions

Pain, Breast

Keywords

Bupivacaine; Liposomal Bupivacaine; Mastectomy; Breast Reconstruction; Pain Control

Outcome Measures

Primary Outcomes (1)

• Mean Visual Analog Scores

  This will be measured every 12 hours for the first 48 hours postoperatively by the level of breast pain associated with arm movements while eating on a scale of 0-10 with higher scores denoting worse outcomes.

  48 hours

Secondary Outcomes (6)

• Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty)

  48 hours

• Number of Morphine Doses Across All Subjects

  1 Month

• Length of Stay for Hospitalization

  up to 47 Hours

• Readmission Rates to the Hospital

  Month 2

• Frequency of Postoperative Opioid Related Adverse Effects

  Postoperatively, 1 week

Study Arms (2)

Bupivacaine Group

EXPERIMENTAL

Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction

Drug: Bupivacaine

Liposomal Bupivacaine Group

EXPERIMENTAL

Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction

Drug: Liposomal Bupivacaine

Interventions

Bupivacaine DRUG

While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.

Also known as: Marcaine

Bupivacaine Group

Liposomal Bupivacaine DRUG

While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.

Also known as: Exparel

Liposomal Bupivacaine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction
• Age ≥ 18 years
• Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
• Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.

You may not qualify if:

• Patients who receive an autologous tissue reconstruction.
• Patients who receive a unilateral reconstruction.
• Patients who are expected to undergo axillary lymph node dissection
• Patients who have undergone breast irradiation
• Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
• Patients who are wards of the state
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
• Pregnant women are excluded from this study because pregnancy precluded immediate breast reconstruction in our patient population.
• Patients who weigh less than 50 kg, as there can be dose related toxicities of the bupivacaine dosing used n this study.
• Patients with moderate-severe hepatic or renal impairment because of the increased risk of toxicity.
• Patients receiving bilateral mastectomy with immediate pre-pectoral implant based reconstruction

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (29)

• Lovecchio F, Jordan SW, Lim S, Fine NA, Kim JY. Risk Factors for Complications Differ Between Stages of Tissue-Expander Breast Reconstruction. Ann Plast Surg. 2015 Sep;75(3):275-80. doi: 10.1097/SAP.0000000000000109.

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  BACKGROUND

• Gassman AA, Yoon AP, Festekjian J, Da Lio AL, Tseng CY, Crisera C. Comparison of immediate postoperative pain in implant-based breast reconstructions. J Plast Reconstr Aesthet Surg. 2016 May;69(5):604-16. doi: 10.1016/j.bjps.2015.12.009. Epub 2016 Jan 7.

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• Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.

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• Viscusi ER, Sinatra R, Onel E, Ramamoorthy SL. The safety of liposome bupivacaine, a novel local analgesic formulation. Clin J Pain. 2014 Feb;30(2):102-10. doi: 10.1097/AJP.0b013e318288e1f6.

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  BACKGROUND

MeSH Terms

Conditions

Mastodynia; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Christopher Runyan
• Organization: Wake Forest Baptist Health

crunyan@wakehealth.edu

336-716-4171

Study Officials

• Christopher M Runyan, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women of all races and ethnicity who meet the above-described eligibility criteria are eligible to participate in this study. Approximately 5% of study participants to be Hispanic/Latino (N=5), 10% Black or African American (N=10), 1% American Indian/Alaska Native (N=1), and 5% Asian (N=5).

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 29, 2018
• Study Start: June 14, 2018
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: October 27, 2022
• Results First Posted: October 27, 2022

Record last verified: 2021-05

Locations

US (1)