Pain, Breast
Conditions
Keywords
Bupivacaine, Liposomal Bupivacaine, Mastectomy, Breast Reconstruction, Pain Control
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.
Interventions
DRUGBupivacaine
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.
DRUGLiposomal 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Morphine Doses Across All Subjects | 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. |
| Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty) | 48 hours | This will be measured during first 48 hours postoperatively |
| 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. |
| Readmission Rates to the Hospital | Month 2 | Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Group Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
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. | 1 |
| Liposomal Bupivacaine Group Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
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. | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Bupivacaine Group | Total | Liposomal Bupivacaine Group |
|---|---|---|---|
| Age, Continuous | 54 years | 50 years | 48 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 3 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
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.
Time frame: 48 hours
Population: Data was not collected for participant in the Bupicaine group at 24, 36 and 48 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bupivacaine Group | Mean Visual Analog Scores | 12 hours | 4 score on a scale |
| Liposomal Bupivacaine Group | Mean Visual Analog Scores | 12 hours | 3.5 score on a scale |
| Liposomal Bupivacaine Group | Mean Visual Analog Scores | 24 hours | 4 score on a scale |
| Liposomal Bupivacaine Group | Mean Visual Analog Scores | 36 hours | 3.5 score on a scale |
| Liposomal Bupivacaine Group | Mean Visual Analog Scores | 48 hours | 2 score on a scale |
Secondary
Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty)
This will be measured during first 48 hours postoperatively
Time frame: 48 hours
Population: Unable to calculate, data not collected at 48hours for Bupivacaine group or Liposomal Bupivacaine Group.
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.
Time frame: Postoperatively, 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine Group | Frequency of Postoperative Opioid Related Adverse Effects | 0 Participants |
| Liposomal Bupivacaine Group | Frequency of Postoperative Opioid Related Adverse Effects | 0 Participants |
Secondary
Length of Stay for Hospitalization
The length of stay for hospitalization after mastectomy and breast reconstruction will be recorded.
Time frame: up to 47 Hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivacaine Group | Length of Stay for Hospitalization | 1 days |
| Liposomal Bupivacaine Group | Length of Stay for Hospitalization | 1 days |
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.
Time frame: 1 Month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupivacaine Group | Number of Morphine Doses Across All Subjects | 0 Number of morphine doses |
| Liposomal Bupivacaine Group | Number of Morphine Doses Across All Subjects | 20 Number of morphine doses |
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.
Time frame: Up to 2 months
Population: Data not collected
Secondary
Readmission Rates to the Hospital
Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded
Time frame: Month 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine Group | Readmission Rates to the Hospital | 0 Participants |
| Liposomal Bupivacaine Group | Readmission Rates to the Hospital | 0 Participants |