Optimizing Recovery in Abdominoplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal Bupivacaine<br>Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. | Drug: Liposomal bupivacaine<br>* Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.<br>|
| Other: Bupivacaine<br>Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. | Other: Standard of care<br>* Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use at 24 hours | Amount of opioids used postoperatively, measured in morphine equivalents | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 
| Incidence of postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting, as measured by frequency of emesis reported by the patient, and subjective feeling of nausea. | 24 hours postoperatively | 
| Incidence of postoperative complications | Incidence of postoperative complications | 1 week postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominoplasty, enhanced recovery after surgery, Liposomal bupivacaine