Trial Outcomes & Findings for Liposomal Bupivacaine in Implant Based Breast Reconstruction (NCT NCT02659501)
NCT ID: NCT02659501
Last Updated: 2021-01-12
Results Overview
Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Average Pain Scores 24 hours Post-Operatively
Results posted on
2021-01-12
Participant Flow
Participant milestones
| Measure |
Bupivacaine With Epinephrine Injections
Patients in the control arm will be treated intra-operatively with standard of care, 0.25% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered to each breast pocket. Postoperatively, pain will be treated with narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Bupivacaine with epinephrine: Bupivacaine is a local anesthetic. This drug is the current standard of care for local anesthesia following breast reconstruction.
Morphine sulfate: Morphine is an opiate pain medication administered intravenously for severe post-operative pain.
Hydrocodone/acetaminophen: Hydrocodone acetaminophen is a combination of an opiate (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Diazepam: Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms.
|
Liposomal Bupivacaine
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to each breast pocket. Postoperatively, pain will be treated with narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Liposomal bupivacaine: Liposomal Bupivacaine is a suspension of multivesicular liposomes containing bupivacaine. After injection, bupivacaine is slowly released from the liposomes, extending this drug's duration of action.
Morphine sulfate: Morphine is an opiate pain medication administered intravenously for severe post-operative pain.
Hydrocodone/acetaminophen: Hydrocodone acetaminophen is a combination of an opiate (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Diazepam: Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms.
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|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liposomal Bupivacaine in Implant Based Breast Reconstruction
Baseline characteristics by cohort
| Measure |
Bupivacaine With Epinephrine Injections
n=12 Participants
Patients in the control arm will be treated intra-operatively with standard of care, 0.25% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered to each breast pocket. Postoperatively, pain will be treated with narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Bupivacaine with epinephrine: Bupivacaine is a local anesthetic. This drug is the current standard of care for local anesthesia following breast reconstruction.
Morphine sulfate: Morphine is an opiate pain medication administered intravenously for severe post-operative pain.
Hydrocodone/acetaminophen: Hydrocodone acetaminophen is a combination of an opiate (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Diazepam: Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms.
|
Liposomal Bupivacaine
n=12 Participants
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to each breast pocket. Postoperatively, pain will be treated with narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Liposomal bupivacaine: Liposomal Bupivacaine is a suspension of multivesicular liposomes containing bupivacaine. After injection, bupivacaine is slowly released from the liposomes, extending this drug's duration of action.
Morphine sulfate: Morphine is an opiate pain medication administered intravenously for severe post-operative pain.
Hydrocodone/acetaminophen: Hydrocodone acetaminophen is a combination of an opiate (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Diazepam: Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms.
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Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average Pain Scores 24 hours Post-OperativelyPostoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.
Outcome measures
| Measure |
Bupivacaine With Epinephrine Injections
n=12 Participants
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
|
Liposomal Bupivacaine
n=12 Participants
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
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|---|---|---|
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The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.
|
3.66 score on a scale
Standard Deviation 0.33
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3.68 score on a scale
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: 24 hoursThe effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively.
Outcome measures
| Measure |
Bupivacaine With Epinephrine Injections
n=12 Participants
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
|
Liposomal Bupivacaine
n=12 Participants
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
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|---|---|---|
|
The Effect of Liposomal Bupivacaine on Antiemetic Consumption
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7.33 mg of ondansetron
Standard Deviation 6.57
|
5.75 mg of ondansetron
Standard Deviation 4.94
|
PRIMARY outcome
Timeframe: 24 hoursPostoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour.
Outcome measures
| Measure |
Bupivacaine With Epinephrine Injections
n=12 Participants
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
|
Liposomal Bupivacaine
n=12 Participants
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
|
|---|---|---|
|
The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption
|
1.31 Morphine equivalent dosage per hour
Standard Deviation .72
|
.76 Morphine equivalent dosage per hour
Standard Deviation .55
|
PRIMARY outcome
Timeframe: 24 hoursBenzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively.
Outcome measures
| Measure |
Bupivacaine With Epinephrine Injections
n=12 Participants
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
|
Liposomal Bupivacaine
n=12 Participants
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
|
|---|---|---|
|
The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption
|
0.35 mg of diazepam/hr
Standard Deviation 0.19
|
0.18 mg of diazepam/hr
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: 24-60 hoursLength of hospital stay will be determined for patients in each group, in total hours.
Outcome measures
| Measure |
Bupivacaine With Epinephrine Injections
n=12 Participants
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
|
Liposomal Bupivacaine
n=12 Participants
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
|
|---|---|---|
|
The Effect of Liposomal Bupivacaine on Length of Hospital Stay
|
46.7 hrs
Standard Deviation 21.1
|
29.8 hrs
Standard Deviation 15.3
|
Adverse Events
Bupivacaine With Epinephrine Injections
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Saba Motakef, Resident Physican
Loma Linda University, Department of Plastic Surgery
Phone: 714-925-8932
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place