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The Use Of Liposomal Bupivacaine For Pain Control

Primary Purpose

Pain, Breast

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine

Liposomal Bupivacaine

About this trial

This is an interventional supportive care trial for Pain, Breast focused on measuring Bupivacaine, Liposomal Bupivacaine, Mastectomy, Breast Reconstruction, Pain Control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Bupivacaine Group

Liposomal Bupivacaine Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

This will be measured during first 48 hours postoperatively

Number of Morphine Doses Across All Subjects

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

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

Readmission Rates to the Hospital

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

Frequency of Postoperative Opioid Related Adverse Effects

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

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

Full Information

NCT ID

NCT03722927

First Posted

October 22, 2018

Last Updated

October 26, 2022

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03722927

Brief Title

The Use Of Liposomal Bupivacaine For Pain Control

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

June 14, 2018 (Actual)

Primary Completion Date

January 29, 2020 (Actual)

Study Completion Date

January 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Breast

Keywords

Bupivacaine, Liposomal Bupivacaine, Mastectomy, Breast Reconstruction, Pain Control

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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).

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine Group

Arm Type

Experimental

Arm Description

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

Arm Title

Liposomal Bupivacaine Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Marcaine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Liposomal Bupivacaine

Other Intervention Name(s)

Exparel

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Visual Analog Scores

Description

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

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

Description

This will be measured during first 48 hours postoperatively

Time Frame

48 hours

Title

Number of Morphine Doses Across All Subjects

Description

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

Time Frame

1 Month

Title

Length of Stay for Hospitalization

Description

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

Time Frame

up to 47 Hours

Title

Readmission Rates to the Hospital

Description

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

Time Frame

Month 2

Title

Frequency of Postoperative Opioid Related Adverse Effects

Description

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

Time Frame

Postoperatively, 1 week

Title

Pain Intensity With Movement

Description

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

Time Frame

Up to 2 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher M Runyan, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

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The Use Of Liposomal Bupivacaine For Pain Control

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