Postoperative Pain
Conditions
Keywords
abdominoplasty, enhanced recovery after surgery, Liposomal bupivacaine
Brief summary
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.
Detailed description
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.
Interventions
DRUGLiposomal bupivacaine
Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.
OTHERStandard of care
Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Medically cleared to undergo elective surgery (including associated anesthesia) at UW Madison Surgery Center (MSC).
Exclusion criteria
* Pregnant or breast-feeding women * Incarcerated women or men * Individuals unable to give consent due to another condition such as impaired decision-making capacity. * Men or women who take opioid pain medications on a regular basis prior to surgery * Men or women with a history of opioid abuse and/or dependence * Participants with a history of bleeding disorders precluding safe abdominoplasty * Participants on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist * Participants not medically cleared for surgery at Madison Surgery Center. This would include participants with sepsis/bacteremia, significant valvular disorders or heart conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use at 24 Hours | 24 hours postoperatively | Amount of opioids used postoperatively, measured in morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Postoperative Day 1 (POD 1) | 24 hours postoperatively | The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain. |
| Pain Score 1 Week Postop | 1 week postoperatively | The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain. |
| Opioid Use at 1 Week | 1 week postoperatively | total opioid used, measure in morphine equivalents |
| Quality of Recovery-40 (QOR-40) Score | 24 hours postoperatively | 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. |
| Antiemetic Use 1 Week | 1 week postoperatively | total antiemetic used |
| Number of Participants With Postoperative Nausea and Vomiting | 24 hours postoperatively | — |
| Number of Participants With Postoperative Complications | 1 week postoperatively | — |
| Antiemetic Use POD 1 | 24 hours postoperatively | total antiemetic used |
Countries
United States
Participant flow
Recruitment details
Data collection occurred from 1/5/2021 to 1/21/2021
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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 | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | Bupivacaine | Total |
|---|---|---|---|
| Age, Continuous | 54 years | 35 years | 45.1 years |
| Body Mass Index (BMI) | 25.8 kilograms per meter squared | 19.1 kilograms per meter squared | 22.5 kilograms per meter squared |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 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 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Opioid Use at 24 Hours
Amount of opioids used postoperatively, measured in morphine equivalents
Time frame: 24 hours postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine | Opioid Use at 24 Hours | 0 morphine milligram equivalents |
| Bupivacaine | Opioid Use at 24 Hours | 15 morphine milligram equivalents |
Secondary
Antiemetic Use 1 Week
total antiemetic used
Time frame: 1 week postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine | Antiemetic Use 1 Week | 0 antiemetic doses |
| Bupivacaine | Antiemetic Use 1 Week | 0 antiemetic doses |
Secondary
Antiemetic Use POD 1
total antiemetic used
Time frame: 24 hours postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine | Antiemetic Use POD 1 | 0 antiemetic doses |
| Bupivacaine | Antiemetic Use POD 1 | 0 antiemetic doses |
Secondary
Number of Participants With Postoperative Complications
Time frame: 1 week postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine | Number of Participants With Postoperative Complications | 0 Participants |
| Bupivacaine | Number of Participants With Postoperative Complications | 0 Participants |
Secondary
Number of Participants With Postoperative Nausea and Vomiting
Time frame: 24 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine | Number of Participants With Postoperative Nausea and Vomiting | 0 Participants |
| Bupivacaine | Number of Participants With Postoperative Nausea and Vomiting | 0 Participants |
Secondary
Opioid Use at 1 Week
total opioid used, measure in morphine equivalents
Time frame: 1 week postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine | Opioid Use at 1 Week | 0 morphine milligram equivalents |
| Bupivacaine | Opioid Use at 1 Week | 0 morphine milligram equivalents |
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.
Time frame: 1 week postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine | Pain Score 1 Week Postop | 2 score on a scale |
| Bupivacaine | Pain Score 1 Week Postop | 1 score on a scale |
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.
Time frame: 24 hours postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine | Pain Score Postoperative Day 1 (POD 1) | 6.5 score on a scale |
| Bupivacaine | Pain Score Postoperative Day 1 (POD 1) | 8 score on a scale |
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.
Time frame: 24 hours postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine | Quality of Recovery-40 (QOR-40) Score | 161 score on a scale |
| Bupivacaine | Quality of Recovery-40 (QOR-40) Score | 168 score on a scale |