Clinical trial NCT04254692: Optimizing Recovery in Abdominoplasty
Official title: Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: abdominoplasty
enhanced recovery after surgery
Liposomal bupivacaine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Opioid Use at 24 Hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Quality of Recovery-40 (QOR-40) Score
timeFrame: 24 hours postoperatively
measure: Pain Score Postoperative Day 1 (POD 1)
timeFrame: 24 hours postoperatively
measure: Pain Score 1 Week Postop
timeFrame: 1 week postoperatively
measure: Opioid Use at 1 Week
timeFrame: 1 week postoperatively
measure: Antiemetic Use POD 1
timeFrame: 24 hours postoperatively
measure: Antiemetic Use 1 Week
timeFrame: 1 week postoperatively
measure: Number of Participants With Postoperative Nausea and Vomiting
timeFrame: 24 hours postoperatively
measure: Number of Participants With Postoperative Complications
timeFrame: 1 week postoperatively
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Madison Surgery Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Hospitals and Clinics
name: Venkat Rao, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: