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Completed

NCT Number: NCT03722927

The Use Of Liposomal Bupivacaine For Pain Control

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

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Key information

Conditions

Pain, Breast Agnosia Mastodynia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

Eligible subjects will be identified prior to surgery. On the day of surgery, each patient will be randomized to be in either Local infiltration of bupivacaine OR liposomal bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25% bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. After this intraoperative injection, patients will not receive any more doses of local anesthetics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Marcaine

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.

Other names: Exparel

Primary outcomes

  1. Mean Visual Analog Scores

    Time frame: 48 hours

    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.

Secondary outcomes

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

    Time frame: 48 hours

    This will be measured during first 48 hours postoperatively

  2. Number of Morphine Doses Across All Subjects

    Time frame: 1 Month

    This will be measured by the number of doses within the first month postoperatively and recorded on pain medication daily diary kept by subject.

  3. Length of Stay for Hospitalization

    Time frame: up to 47 Hours

    The length of stay for hospitalization after mastectomy and breast reconstruction will be recorded.

  4. Readmission Rates to the Hospital

    Time frame: Month 2

    Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded

  5. Frequency of Postoperative Opioid Related Adverse Effects

    Time frame: Postoperatively, 1 week

    Frequency of postoperative opioid related adverse effects within the first week of surgery will be recorded. This includes nausea, vomiting, pruritus, allergy, respiratory depression.

  6. Pain Intensity With Movement

    Time frame: Up to 2 months

    This will be measured by using the Pain Assessment Questionnaire. Total scores are 0-50 with higher scores denoting worse outcomes.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

The Use of Liposomal Bupivacaine for Pain Control Following Mastectomy and Breast Reconstruction

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2018
Registry last updated
Oct 27, 2022

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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