Optimizing Recovery in Abdominoplasty
Primary Purpose
Postoperative Pain
Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring abdominoplasty, enhanced recovery after surgery, Liposomal bupivacaine
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.
Sites / Locations
- University of Wisconsin Madison Surgery Center
- University of Wisconsin Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Liposomal Bupivacaine
Bupivacaine
Arm Description
Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.
Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.
Outcomes
Primary Outcome Measures
Opioid use at 24 hours
Amount of opioids used postoperatively, measured in morphine equivalents
Secondary Outcome Measures
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.
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.
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.
Opioid use at 1 week
total opioid used, measure in morphine equivalents
Antiemetic use POD 1
total antiemetic used
Antiemetic use 1 week
total antiemetic used
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.
Incidence of postoperative complications
Incidence of postoperative complications
Full Information
NCT ID
NCT04254692
First Posted
December 23, 2019
Last Updated
September 28, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04254692
Brief Title
Optimizing Recovery in Abdominoplasty
Official Title
Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
division wide research suspension
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
abdominoplasty, enhanced recovery after surgery, Liposomal bupivacaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine
Arm Type
Active Comparator
Arm Description
Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.
Arm Title
Bupivacaine
Arm Type
Other
Arm Description
Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Primary Outcome Measure Information:
Title
Opioid use at 24 hours
Description
Amount of opioids used postoperatively, measured in morphine equivalents
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Quality of Recovery-40 (QOR-40) Score
Description
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
Title
Pain score Postoperative Day 1 (POD 1)
Description
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
Title
Pain score 1 week postop
Description
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
Title
Opioid use at 1 week
Description
total opioid used, measure in morphine equivalents
Time Frame
1 week postoperatively
Title
Antiemetic use POD 1
Description
total antiemetic used
Time Frame
24 hours postoperatively
Title
Antiemetic use 1 week
Description
total antiemetic used
Time Frame
1 week postoperatively
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting, as measured by frequency of emesis reported by the patient, and subjective feeling of nausea.
Time Frame
24 hours postoperatively
Title
Incidence of postoperative complications
Description
Incidence of postoperative complications
Time Frame
1 week postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkat Rao, MD, MBA
Organizational Affiliation
University of Wisconsin Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Madison Surgery Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimizing Recovery in Abdominoplasty
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