Pain, Breast Clinical Trial
Official title:
The Use of Liposomal Bupivacaine for Pain Control Following Mastectomy and Breast Reconstruction
Verified date | May 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
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Wake Forest University Health Sciences |
United States,
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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 |