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| ID | Type | Description | Link |
|---|---|---|---|
| A539730 | Other Identifier | UW Madison | |
| SMPH/SURGERY/DENTL-PLASTC SRGY | Other Identifier | UW Madison | |
| Protocol Ver 2, 04/09/2021 | Other Identifier | UW Madison |
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division wide research suspension
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The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of postoperative nausea and vomiting (PONV), and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in 46 participants 18 years and older undergoing elective abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.
Postoperative pain, nausea, and vomiting can be frustrating sequelae of elective surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. Despite the use of multiple techniques for managing postoperative pain in abdominoplasty patients, pain control continues to be a challenge for this patient population.
One technique commonly employed to improve pain control is the use of abdominal wall and incisional injection of local anesthetic agents to block the sensory nerves supplying the anterior abdominal wall and abdominal incisions in order to decrease sensation and pain in the abdomen in the setting of abdominoplasty surgery. Local anesthetic often used in this procedure is bupivacaine (Marcaine) ± epinephrine. However, in 2012, a liposomal bupivacaine suspension (Exparel; Pacira BioSciences, Inc, San Diego, California) was introduced as a longer-acting local anesthetic used for management of postoperative pain. At the University of Wisconsin, patients undergoing abdominoplasty routinely receive intraoperative injection of local anesthetic to the abdominal wall and abdominal incisions, using bupivacaine as the local anesthetic, along with standard multimodal perioperative pain management including cool compresses, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids.
The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of PONV, and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in patients undergoing abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Active Comparator | Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. |
|
| Bupivacaine | Other | Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use at 24 Hours | Amount of opioids used postoperatively, measured in morphine equivalents | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-40 (QOR-40) Score | The QOR-40 is a 40 item survey about the quality of recovery with a total possible range of scores from 40 to 200 where the higher the score the higher quality the recovery. | 24 hours postoperatively |
| Pain Score Postoperative Day 1 (POD 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Venkat Rao, MD, MBA | University of Wisconsin Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Madison Surgery Center | Madison | Wisconsin | 53715 | United States | ||
| University of Wisconsin Madison |
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Data collection occurred from 1/5/2021 to 1/21/2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall. |
| FG001 | Bupivacaine | Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Use at 24 Hours | Amount of opioids used postoperatively, measured in morphine equivalents | Posted | Number | morphine milligram equivalents | 24 hours postoperatively |
|
up to 1 week post op
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine | Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall. |
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study terminated early, not powered for meaningful results
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Venkat Rao, MD, MBA | University of Wisconsin School of Medicine and Public Health | (608) 263-1223 | rao@surgery.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2021 | May 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Other | Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall |
|
The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain. |
| 24 hours postoperatively |
| Pain Score 1 Week Postop | The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain. | 1 week postoperatively |
| Opioid Use at 1 Week | total opioid used, measure in morphine equivalents | 1 week postoperatively |
| Antiemetic Use POD 1 | total antiemetic used | 24 hours postoperatively |
| Antiemetic Use 1 Week | total antiemetic used | 1 week postoperatively |
| Number of Participants With Postoperative Nausea and Vomiting | 24 hours postoperatively |
| Number of Participants With Postoperative Complications | 1 week postoperatively |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| BG001 |
| Bupivacaine |
Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Number | kilograms per meter squared |
|
|
|
| Secondary | Quality of Recovery-40 (QOR-40) Score | The QOR-40 is a 40 item survey about the quality of recovery with a total possible range of scores from 40 to 200 where the higher the score the higher quality the recovery. | Posted | Number | score on a scale | 24 hours postoperatively |
|
|
|
| Secondary | Pain Score Postoperative Day 1 (POD 1) | The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain. | Posted | Number | score on a scale | 24 hours postoperatively |
|
|
|
| Secondary | Pain Score 1 Week Postop | The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain. | Posted | Number | score on a scale | 1 week postoperatively |
|
|
|
| Secondary | Opioid Use at 1 Week | total opioid used, measure in morphine equivalents | Posted | Number | morphine milligram equivalents | 1 week postoperatively |
|
|
|
| Secondary | Antiemetic Use POD 1 | total antiemetic used | Posted | Number | antiemetic doses | 24 hours postoperatively |
|
|
|
| Secondary | Antiemetic Use 1 Week | total antiemetic used | Posted | Number | antiemetic doses | 1 week postoperatively |
|
|
|
| Secondary | Number of Participants With Postoperative Nausea and Vomiting | Posted | Count of Participants | Participants | 24 hours postoperatively |
|
|
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| Secondary | Number of Participants With Postoperative Complications | Posted | Count of Participants | Participants | 1 week postoperatively |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Bupivacaine | Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall | 0 | 1 | 0 | 1 | 0 | 1 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |