Mammaplasty
Conditions
Brief summary
This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.
Interventions
DRUGBupivicaine HCL
DRUGLiposomal bupivacaine
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM). * At least 18 years of age. * Female. * Able to understand and willing to sign a written informed consent document.
Exclusion criteria
* Cognitive impairment. * History of abdominal surgery precluding free flap donor site. * Allergy or intolerance to bupivacaine or amide anesthetics. * Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months. * Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Up to day of discharge from hospital (expected hospital stay of 5 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay | Up to day of discharge from hospital, up to 7 days | — |
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation | Up to 2 weeks post-operation | — |
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter | Up to 2 weeks post-operation | — |
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay | Up to day of discharge from hospital (expected hospital stay of 5 days) | — |
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery | At post operative day 2, discharge, and at 1-2 week follow-up | * Quality of Recovery -15 questionnaire * Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time * Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time. * The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling |
| Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics | Up to 2 weeks post-operation | — |
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 12 hours after surgery | * Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Bupivicaine -TAP block of 30 cc of 0.25% bupivicaine | 35 |
| Group 2: Liposomal Bupivacaine -TAP block of 266 mg/30 cc liposomal bupivacaine | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Group 1: Bupivicaine | Group 2: Liposomal Bupivacaine | Total |
|---|---|---|---|
| Age, Continuous | 51 years | 47 years | 48.5 years |
| Baseline QoR | 134 score on a scale | 140 score on a scale | 136 score on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 34 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 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 | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 30 Participants | 28 Participants | 58 Participants |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 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 / 22 | 0 / 22 |
| other Total, other adverse events | 8 / 22 | 10 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
Time frame: Up to day of discharge from hospital (expected hospital stay of 5 days)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Intraoperative | 99.5 mg |
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Postoperative floor | 165 mg |
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Postoperative acute care unit | 0 mg |
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Total | 300 mg |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Total | 283 mg |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Intraoperative | 110.0 mg |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Postoperative acute care unit | 10 mg |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay | Postoperative floor | 138.8 mg |
Comparison: Statistical analysis #1 is for intraoperative opioid usep-value: 0.76Mann Whitney U Test
Comparison: Statistical analysis #2 is for postoperative acute care unit opioid usep-value: 0.38Mann Whitney U Test
Comparison: Statistical analysis #3 is for postoperative floor opioid usep-value: 0.69Mann Whitney U Test
Comparison: Statistical analysis #4 is for total opioid usep-value: 0.98Mann Whitney U Test
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
Time frame: Up to day of discharge from hospital (expected hospital stay of 5 days)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay | Postoperative acute care unit | 0 mg |
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay | Floor | 1 mg |
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay | Total | 1 mg |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay | Postoperative acute care unit | 0 mg |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay | Floor | 1 mg |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay | Total | 1 mg |
Comparison: Statistical analysis #1 is for postoperative acute care unit antiemetic usep-value: 0.28Mann Whitney U Test
Comparison: Statistical analysis #2 is for floor antiemetic usep-value: 0.62Mann Whitney U Test
Comparison: Statistical analysis #3 is for total antiemetic usep-value: 0.5Mann Whitney U Test
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
* Quality of Recovery -15 questionnaire * Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time * Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time. * The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling
Time frame: At post operative day 2, discharge, and at 1-2 week follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery | Post-operative day 2 | -33 score on a scale |
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery | Discharge | -10 score on a scale |
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery | 1-2 week follow-up | -18.5 score on a scale |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery | Post-operative day 2 | -24 score on a scale |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery | Discharge | -6 score on a scale |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery | 1-2 week follow-up | -10 score on a scale |
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter
Time frame: Up to 2 weeks post-operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter | 1.27 days |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter | 1.02 days |
p-value: 0.38Mann Whitney U Test
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay
Time frame: Up to day of discharge from hospital, up to 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay | 3.56 days |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay | 2.91 days |
p-value: 0.2Mann Whitney U Test
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
* Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Time frame: 12 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 2.0 score on a scale |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 0 score on a scale |
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
* Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 2.0 score on a scale |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 3 score on a scale |
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
* Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 2 score on a scale |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 2 score on a scale |
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
* Pain scale uses Wong-Baker FACES Pain Rating Scale * The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Time frame: 72 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 2 score on a scale |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | 0.5 score on a scale |
Secondary
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation
Time frame: Up to 2 weeks post-operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Bupivicaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation | 2.20 days |
| Group 2: Liposomal Bupivacaine | Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation | 1.81 days |
p-value: 0.64Mann Whitney U Test
Secondary
Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics
Time frame: Up to 2 weeks post-operation
Population: Data was not collected for this outcome measure. There was no funding to collect or analyze the data. Also it was determined that the concept of cost was highly variable at the hospital and any data that was obtained would lack granular costs on most items. Lacking this granularity would make any results meaningless.