Postoperative PainPhase 4NCT04254692
Optimizing Recovery in Abdominoplasty
A Phase 4 study testing Liposomal bupivacaine in people with Postoperative Pain, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Liposomal bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2021to 21 Jan 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically cleared to undergo elective surgery (including associated anesthesia) at UW Madison Surgery Center (MSC).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin Madison Surgery Center
Madison, Wisconsin, 53715
University of Wisconsin Madison
Madison, Wisconsin, 53792
About this study
Official title: Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Liposomal bupivacaine, Standard of care
- Keywords
- abdominoplasty, enhanced recovery after surgery, Liposomal bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.
Standard of careOther
Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Receives: Drug: Liposomal bupivacaine |
| Bupivacaine | Other | Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use at 24 Hours
Amount of opioids used postoperatively, measured in morphine equivalents
Measured: 24 hours postoperatively
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 1 week postoperatively
Opioid Use at 1 Week
total opioid used, measure in morphine equivalents
Measured: 1 week postoperatively
Antiemetic Use POD 1
total antiemetic used
Measured: 24 hours postoperatively
Antiemetic Use 1 Week
total antiemetic used
Measured: 1 week postoperatively
Number of Participants With Postoperative Nausea and Vomiting
Measured: 24 hours postoperatively
Number of Participants With Postoperative Complications
Measured: 1 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start5 Jan 2021
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Why it stopped: division wide research suspension
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venkat Rao, MD, MBA, Principal investigator, University of Wisconsin Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254692
- Sponsor's protocol ID
- 2019-1570
- Other IDs
- A539730, SMPH/SURGERY/DENTL-PLASTC SRGY, Protocol Ver 2, 04/09/2021
- Status last verified
- Jul 2024
- First submitted
- 23 Dec 2019
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty
- ClinicalTrials.gov ID
- NCT04254692
- Acronym / sponsor ID
- 2019-1570
- Conditions
- Postoperative Pain
- Keywords
- abdominoplasty, enhanced recovery after surgery, Liposomal bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: division wide research suspension
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 7 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | Drug: Liposomal bupivacaineParticipants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. |
| Bupivacaine | Other | Other: Standard of careParticipants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medically cleared to undergo elective surgery (including associated anesthesia) at UW Madison Surgery Center (MSC).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineParticipants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall. | Drug | Liposomal Bupivacaine |
| Standard of careParticipants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall | Other | Bupivacaine |
Primary outcome
Opioid Use at 24 Hours
Time frame: 24 hours postoperatively
Amount of opioids used postoperatively, measured in morphine equivalents
8 secondary outcomes
Quality of Recovery-40 (QOR-40) Score
Time frame: 24 hours postoperatively
Pain Score Postoperative Day 1 (POD 1)
Time frame: 24 hours postoperatively
Pain Score 1 Week Postop
Time frame: 1 week postoperatively
Opioid Use at 1 Week
Time frame: 1 week postoperatively
Antiemetic Use POD 1
Time frame: 24 hours postoperatively
Antiemetic Use 1 Week
Time frame: 1 week postoperatively
Number of Participants With Postoperative Nausea and Vomiting
Time frame: 24 hours postoperatively
Number of Participants With Postoperative Complications
Time frame: 1 week postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkat Rao, MD, MBA principal investigator
University of Wisconsin Hospitals and Clinics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine in people with Postoperative Pain, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use at 24 Hours (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.