The Use Of Liposomal Bupivacaine For Pain Control

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Pain, Breast

Treatments: Drug: Bupivacaine; Drug: Liposomal Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03722927

IRB00045562

Details and patient eligibility

About

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

Full description

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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups

Bupivacaine Group

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine

Liposomal Bupivacaine Group

Experimental group

Description:

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

Treatment:

Drug: Liposomal Bupivacaine