The Use Of Liposomal Bupivacaine For Pain Control

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03722927

Collaborator

(none)

Enrollment

Location

Arms

19.5

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Breast	Drug: Bupivacaine Drug: Liposomal Bupivacaine	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 14, 2018

Actual Primary Completion Date :

Jan 29, 2020

Actual Study Completion Date :

Jan 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine Group Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction	Drug: Bupivacaine 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
Experimental: Liposomal Bupivacaine Group Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction	Drug: Liposomal Bupivacaine 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

Arm

Intervention/Treatment

Experimental: Bupivacaine Group

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

Drug: Bupivacaine

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

Experimental: Liposomal Bupivacaine Group

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

Drug: Liposomal Bupivacaine

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

Outcome Measures

Primary Outcome Measures

Mean Visual Analog Scores [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 Outcome Measures

Area under the curve Visual Analog Scores (Submuscular Augmentation Mammoplasty) [48 hours]
This will be measured during first 48 hours postoperatively on a scale of 0-10 with higher scores denoting worse outcomes
Morphine Equivalents [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.
Length of Stay for hospitalization [up to 47 Hours]
The length of stay for hospitalization after mastectomy and breast reconstruction will be recorded.
Readmission rates to the hospital [Month 2]
Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded
Frequency of postoperative opioid related adverse effects [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.
Pain intensity with movement [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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