The Use Of Liposomal Bupivacaine For Pain Control

Pain, Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722927
• Other study ID #: IRB00045562
• Status: Completed
• Phase: Phase 4
• Start date: June 14, 2018
• Est. completion date: January 29, 2020

Study information

• Verified date: May 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mastodynia
• Pain, Breast

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty)	This will be measured during first 48 hours postoperatively	48 hours
Secondary	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.	1 Month
Secondary	Length of Stay for Hospitalization	The length of stay for hospitalization after mastectomy and breast reconstruction will be recorded.	up to 47 Hours
Secondary	Readmission Rates to the Hospital	Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded	Month 2
Secondary	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.	Postoperatively, 1 week
Secondary	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.	Up to 2 months