Bariatric Surgery CandidatePhase 1NCT06077214
Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients
A Phase 1 study testing Treatment with liposomal bupivacaine and Treatment with standard bupivacaine in people with Bariatric Surgery Candidate and Post-operative Pain, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Liposomal bupivacaine (trade name Exparel) is a local analgesic that is designed to produce more long-term pain control. Bupivacaine, a widely used local analgesic, is stored within liposomes, which break down in soft tissue over time. Typical length of therapeutic effect for standard bupivacaine is up to 6 hours. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Bariatric Surgery Candidate, Post-operative Pain
- What is being tested?
- Treatment with liposomal bupivacaine and Treatment with standard bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 20 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients who are undergoing a laparoscopic sleeve gastrectomy for severe obesity who are between 13 and 2018 years of age.
- Only patients treated at the Children's Hospital of Richmond at VCU will be included.
Who cannot join
- patients less than 13 or greater than 2018 years of age
- patients with an allergy to bupivacaine
- any patients undergoing any additional procedures at the time of the laparoscopic sleeve gastrectomy.
- English or Spanish proficiency will be necessary.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Liposomal bupivacaine (trade name Exparel) is a local analgesic that is designed to produce more long-term pain control. Bupivacaine, a widely used local analgesic, is stored within liposomes, which break down in soft tissue over time. Typical length of therapeutic effect for standard bupivacaine is up to 6 hours. The liposomal formulation of bupivacaine, however, has a length of therapeutic effect of up to 72 hours. Typical post-operative incisional pain is known to last for several days in most cases and is thought to peak between 1-2 days after surgery. Therefore, the benefit of most short-acting local analgesics does not overlap with the period of most need.
Read the detailed description
Use of liposomal bupivacaine has not been reported specifically for use in adolescent bariatric surgery. Our rationale is based on the notion that for most minimally invasive procedures, methods currently used for pain control provide good outcomes that liposomal bupivacaine may not necessarily be able to improve upon. It is critically important to minimize the narcotics for our bariatric surgical patients so they are mobilized early and frequently to minimize their risk for a deep venous thrombosis, which could become a pulmonary embolus. In addition, as these patients are prone to constipation after their operation as a result of their 2 week protein sparing liquid diet preoperatively, avoiding narcotics can reduce their chances of further challenges in return of their bowel function. For these reasons, we seek to investigate whether incorporating liposomal bupivacaine in the analgesic regimen for patients undergoing a laparoscopic sleeve gastrectomy will lead to improvements in patient-reported outcomes and decreased opioid utilization.
- Conditions
- Bariatric Surgery Candidate, Post-operative Pain
- Being tested
- Treatment with liposomal bupivacaine, Treatment with standard bupivacaine
- Keywords
- liposomal bupivacaine, Exparel
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with liposomal bupivacaineDrug
Also called Exparel
Patients will randomly be treated with either liposomal bupivacaine (study drug) after undergoing bariatric surgery.
Treatment with standard bupivacaineDrug
Patients will randomly be treated with standard bupivacaine after undergoing bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experiemental | Experimental | Subjects will be treated with liposomal bupivacaine (study drug) after undergoing bariatric surgery. Receives: Drug: Treatment with liposomal bupivacaine |
| Standard of Care | Active comparator | Subjects will be treated with standard bupivacaine after undergoing bariatric surgery. Receives: Drug: Treatment with standard bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed pain scores using liposomal bupivacaine day 1 post-operative
Using the 10 point pain scale, determine if liposomal bupivacaine use leads to changed pain scores on post-operative day 1 compared to standard analgesics after laparoscopic sleeve gastrectomy.
Measured: Day 1 post-operative
Secondary outcomes (2)
Changed pain scores liposomal bupivacaine days 0, 2,3 post-operative
Using the 10 point pain scale,determine if liposomal bupivacaine use leads to changed pain scores on post-operative days 0, 2, and 3 compared to standard analgesics after laparoscopic sleeve gastrectomy.
Measured: Days 0, 2, 3 post-operative
Changed use of opioid medications post operative days 0-3
To determine if liposomal bupivacaine use leads to changed total consumption of opioid medications after laparoscopic sleeve gastrectomy.
Measured: Post-operative days 0-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start31 Jan 2023
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will randomly be treated with either liposomal bupivacaine (study drug) or standard bupivacaine after undergoing bariatric surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Sulkowski, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077214
- Sponsor's protocol ID
- HM20025041
- Status last verified
- Mar 2025
- First submitted
- 4 Oct 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients
- ClinicalTrials.gov ID
- NCT06077214
- Acronym / sponsor ID
- HM20025041
- Conditions
- Bariatric Surgery Candidate, Post-operative Pain
- Keywords
- liposomal bupivacaine, Exparel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liposomal bupivacaine (trade name Exparel) is a local analgesic that is designed to produce more long-term pain control. Bupivacaine, a widely used local analgesic, is stored within liposomes, which break down in soft tissue over time. Typical length of therapeutic effect for standard bupivacaine is up to 6 hours. The liposomal formulation of bupivacaine, however, has a length of therapeutic effect of up to 72 hours. Typical post-operative incisional pain is known to last for several days in most cases and is thought to peak between 1-2 days after surgery. Therefore, the benefit of most short-acting local analgesics does not overlap with the period of most need.
Detailed description
Use of liposomal bupivacaine has not been reported specifically for use in adolescent bariatric surgery. Our rationale is based on the notion that for most minimally invasive procedures, methods currently used for pain control provide good outcomes that liposomal bupivacaine may not necessarily be able to improve upon. It is critically important to minimize the narcotics for our bariatric surgical patients so they are mobilized early and frequently to minimize their risk for a deep venous thrombosis, which could become a pulmonary embolus. In addition, as these patients are prone to constipation after their operation as a result of their 2 week protein sparing liquid diet preoperatively, avoiding narcotics can reduce their chances of further challenges in return of their bowel function. For these reasons, we seek to investigate whether incorporating liposomal bupivacaine in the analgesic regimen for patients undergoing a laparoscopic sleeve gastrectomy will lead to improvements in patient-reported outcomes and decreased opioid utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will randomly be treated with either liposomal bupivacaine (study drug) or standard bupivacaine after undergoing bariatric surgery.
| Arm | Type | Receives |
|---|---|---|
| Experiemental | Experimental | Drug: Treatment with liposomal bupivacaineSubjects will be treated with liposomal bupivacaine (study drug) after undergoing bariatric surgery. |
| Standard of Care | Active comparator | Drug: Treatment with standard bupivacaineSubjects will be treated with standard bupivacaine after undergoing bariatric surgery. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients who are undergoing a laparoscopic sleeve gastrectomy for severe obesity who are between 13 and 2018 years of age.
- Only patients treated at the Children's Hospital of Richmond at VCU will be included.
Key exclusion criteria (4 listed)
- patients less than 13 or greater than 2018 years of age
- patients with an allergy to bupivacaine
- any patients undergoing any additional procedures at the time of the laparoscopic sleeve gastrectomy.
- English or Spanish proficiency will be necessary.
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 |
|---|---|---|
| Treatment with liposomal bupivacaineAlso: ExparelPatients will randomly be treated with either liposomal bupivacaine (study drug) after undergoing bariatric surgery. | Drug | Experiemental |
| Treatment with standard bupivacainePatients will randomly be treated with standard bupivacaine after undergoing bariatric surgery. | Drug | Standard of Care |
Primary outcome
Changed pain scores using liposomal bupivacaine day 1 post-operative
Time frame: Day 1 post-operative
Using the 10 point pain scale, determine if liposomal bupivacaine use leads to changed pain scores on post-operative day 1 compared to standard analgesics after laparoscopic sleeve gastrectomy.
2 secondary outcomes
Changed pain scores liposomal bupivacaine days 0, 2,3 post-operative
Time frame: Days 0, 2, 3 post-operative
Changed use of opioid medications post operative days 0-3
Time frame: Post-operative days 0-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
Jason Sulkowski principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment with liposomal bupivacaine and Treatment with standard bupivacaine in people with Bariatric Surgery Candidate and Post-operative Pain, run by Virginia Commonwealth University at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changed pain scores using liposomal bupivacaine day 1 post-operative (time frame: Day 1 post-operative). 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 Mar 2025.