Cleft Lip and PalatePhase 3NCT06284434
Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
A Phase 3 study testing Liposomal Bupivacaine, Bupivacain and Epinephrine in people with Cleft Lip and Palate, run by Kerry O'Rourke at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Liposomal Bupivacaine, Bupivacain and Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 24 Apr 2026
- Phase
- Phase 3
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients that are 6 and older who have a diagnosis of cleft lip and/or palate with a scheduled surgery that involves an alveolar bone graft.
Who cannot join
- Patients under age 6 are excluded from this study as EXPAREL® is not FDA approved for this group.
- Patients with a history of allergic or adverse reaction to any drug involved in the study (EXPAREL, Epinephrine, or Bupivacaine).
- Patients with a history of cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shriners Children's Chicago
Chicago, Illinois, 60707
Benjamin M Smith, MS, 773-385-5865, benjaminm.smith@shrinenet.org
Chad A Purnell, MD
About this study
The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:
- pain scores at hip and jaw sites
- opioid use in amount and frequency
- scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine.
Read the detailed description
The study is a randomized, double-blinded trial comparing liposomal bupivacaine (EXPAREL®) with epinephrine (0.25%) local anesthetic with the standard treatment of bupivacaine with epinephrine (0.25%) local anesthetic. The study will enroll patients with cleft lip and palate undergoing an alveolar bone graft (ABG) surgery. Researchers will enroll a maximum of 60 patients from Shriners Children's Chicago over a 2-year period.
After this surgery, patients experience significant pain. Considering both the frequency of reported pain after ABG combined with the current opioid crisis and subsequent recommendations by organizations such as the American Society of Anesthesiologists Task Force on Acute Pain Management and Guidelines from the Society for Pediatric Anesthesia for alternative pain management, the use of liposomal bupivacaine (EXPAREL®) is a potential alternative to reduce post-operative pain in the pediatric ABG population.
Liposomal bupivacaine (LB) is an injectable form of bupivacaine used at the surgical site and that is released over time. Studies have shown that LB better controls pain, especially during the first 24 hours post-surgery. Better pain control has been associated with a reduction in opioid usage and its associated complications.
The study is designed to randomize patients to either the standard of care (bupivacaine with epinephrine) or liposomal bupivacaine with epinephrine to better study pain management within the first five days after ABG surgery in Shriners' cleft lip and palate patients.
The FDA approved EXPAREL® for the adult population in 2011 and for the pediatric population, age 6 years and older in 2021. It is a locally injected single dose analgesia that is released over 72 hours.
The study is considered minimal risk because LB use does not present an increased risk over the standard of care (standard bupivacaine) as it is an alternative form of the same pain medication. Previous studies have shown no additional risk to using the liposomal version of bupivacaine vs standard bupivacaine in ABG surgeries.
Patients will participate up to 5 days following surgery (surgery day is considered day 0) with reported pain, activity scores, and opioid use collected through either paper, electronic, or phone questionnaires. Surgeons and patients will be unaware of which cohort the patient will be randomized to be part of. The pharmacist, anesthesiologist, and research coordinator may all be aware of which drug is administered.
Researchers will obtain informed consent from the participants and/or their legally authorized representatives before surgery.
- Conditions
- Cleft Lip and Palate
- Being tested
- Liposomal Bupivacaine, Bupivacain, Epinephrine
- Keywords
- cleft lip, cleft palate, alveolar bone graft, pain management, liposomal bupivacaine
- Medical subject headings
- Cleft Lip, Cleft Palate, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
Also called EXPAREL
Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.
BupivacainDrug
Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.
EpinephrineDrug
Also called Adrenalin
Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.
| Study group | Role | What they receive |
|---|---|---|
| LB Treatment Arm | Experimental | Patients on the treatment arm will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000), which is not considered the standard of care. Receives: Drug: Liposomal Bupivacaine; Drug: Epinephrine |
| Bupivacaine Control Arm | Active comparator | Patients on the control arm will follow the current standard of care, which is traditional bupivacaine mixed with epinephrine (1:100,000). Receives: Drug: Bupivacain; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scores
Pain scores at hip and jaw sites. Pain is rated on a 0 to 10 scale with 0 representing no pain and 10 representing agonizing pain with unbearable distress. A lower score is ideal for improved pain management.
Measured: on Day 1 to Day 5 after surgery
Opioid Use
Opioid use in amount and frequency
Measured: on Day 1 to Day 5 after surgery
PROMIS Pediatric Mobility Questionnaire
The patient will log activity level using the Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Mobility scale. The categorical answers to the questions are the minimum value "not able to do", "with a lot of trouble", "with some trouble", "with a little trouble", and the maximum value "with no trouble." Therefore a higher amount of reported with no trouble categorical answers would represent improved mobility.
Measured: on Day 1 to Day 5 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start24 Apr 2024
- Primary completion24 Apr 2026 (estimated)
- Study completion24 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design of this study is a randomized control trial, double-blinded. Patients who meet criteria and consent will be randomized to receive LB or standard bupivacaine.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerry O'Rourke
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Sponsor-investigator, Kerry O'Rourke, Shriners Hospitals for Children
- Investigators
- Chad A. Purnell, MD, Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284434
- Sponsor's protocol ID
- CHI2311
- Status last verified
- Jul 2024
- First submitted
- 21 Feb 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chughtai M, Sultan AA, Hudson B, Goodwin RC, Seif J, Khlopas A, Bena J, Jin Y, Gurd DP, Kuivila TE, Ballock RT. Liposomal Bupivacaine Is Both Safe and Effective in Controlling Postoperative Pain After Spinal Surgery in Children: A Controlled Cohort Study. Clin Spine Surg. 2020 Dec;33(10):E533-E538. doi: 10.1097/BSD.0000000000000996.
PubMed 32324672Crowley JS, McLean P, Gabriel RA, Cronin B, Hsieh S, Englar K, Said E, Lance S, Gosman A. The Association of Liposomal Bupivacaine on Opioid Consumption in the Pediatric Alveolar Cleft Population. J Craniofac Surg. 2020 Jun;31(4):1078-1081. doi: 10.1097/SCS.0000000000006310.
PubMed 32195834Flowers T, Winters R. Postoperative pain management in pediatric cleft lip and palate repair. Curr Opin Otolaryngol Head Neck Surg. 2021 Aug 1;29(4):294-298. doi: 10.1097/MOO.0000000000000719.
PubMed 34183559Patel RA, Jablonka EM, Rustad KC, Pridgen BC, Sorice-Virk SS, Borrelli MR, Khosla RK, Lorenz HP, Momeni A, Wan DC. Retrospective cohort-based comparison of intraoperative liposomal bupivacaine versus bupivacaine for donor site iliac crest analgesia during alveolar bone grafting. J Plast Reconstr Aesthet Surg. 2019 Dec;72(12):2056-2063. doi: 10.1016/j.bjps.2019.09.026. Epub 2019 Oct 2.
PubMed 31648962
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
- ClinicalTrials.gov ID
- NCT06284434
- Acronym / sponsor ID
- CHI2311
- Conditions
- Cleft Lip and Palate
- Keywords
- cleft lip, cleft palate, alveolar bone graft, pain management, liposomal bupivacaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kerry O'RourkeUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 24 Apr 2026 (estimated)
- Study completion
- 24 Apr 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:
- pain scores at hip and jaw sites
- opioid use in amount and frequency
- scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine.
Detailed description
The study is a randomized, double-blinded trial comparing liposomal bupivacaine (EXPAREL®) with epinephrine (0.25%) local anesthetic with the standard treatment of bupivacaine with epinephrine (0.25%) local anesthetic. The study will enroll patients with cleft lip and palate undergoing an alveolar bone graft (ABG) surgery. Researchers will enroll a maximum of 60 patients from Shriners Children's Chicago over a 2-year period.
After this surgery, patients experience significant pain. Considering both the frequency of reported pain after ABG combined with the current opioid crisis and subsequent recommendations by organizations such as the American Society of Anesthesiologists Task Force on Acute Pain Management and Guidelines from the Society for Pediatric Anesthesia for alternative pain management, the use of liposomal bupivacaine (EXPAREL®) is a potential alternative to reduce post-operative pain in the pediatric ABG population.
Liposomal bupivacaine (LB) is an injectable form of bupivacaine used at the surgical site and that is released over time. Studies have shown that LB better controls pain, especially during the first 24 hours post-surgery. Better pain control has been associated with a reduction in opioid usage and its associated complications.
The study is designed to randomize patients to either the standard of care (bupivacaine with epinephrine) or liposomal bupivacaine with epinephrine to better study pain management within the first five days after ABG surgery in Shriners' cleft lip and palate patients.
The FDA approved EXPAREL® for the adult population in 2011 and for the pediatric population, age 6 years and older in 2021. It is a locally injected single dose analgesia that is released over 72 hours.
The study is considered minimal risk because LB use does not present an increased risk over the standard of care (standard bupivacaine) as it is an alternative form of the same pain medication. Previous studies have shown no additional risk to using the liposomal version of bupivacaine vs standard bupivacaine in ABG surgeries.
Patients will participate up to 5 days following surgery (surgery day is considered day 0) with reported pain, activity scores, and opioid use collected through either paper, electronic, or phone questionnaires. Surgeons and patients will be unaware of which cohort the patient will be randomized to be part of. The pharmacist, anesthesiologist, and research coordinator may all be aware of which drug is administered.
Researchers will obtain informed consent from the participants and/or their legally authorized representatives before surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The design of this study is a randomized control trial, double-blinded. Patients who meet criteria and consent will be randomized to receive LB or standard bupivacaine.
| Arm | Type | Receives |
|---|---|---|
| LB Treatment Arm | Experimental | Drug: Liposomal Bupivacaine, Drug: EpinephrinePatients on the treatment arm will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000), which is not considered the standard of care. |
| Bupivacaine Control Arm | Active comparator | Drug: Bupivacain, Drug: EpinephrinePatients on the control arm will follow the current standard of care, which is traditional bupivacaine mixed with epinephrine (1:100,000). |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that are 6 and older who have a diagnosis of cleft lip and/or palate with a scheduled surgery that involves an alveolar bone graft.
Key exclusion criteria (3 listed)
- Patients under age 6 are excluded from this study as EXPAREL® is not FDA approved for this group.
- Patients with a history of allergic or adverse reaction to any drug involved in the study (EXPAREL, Epinephrine, or Bupivacaine).
- Patients with a history of cardiovascular disease.
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 BupivacaineAlso: EXPARELPatients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery. | Drug | LB Treatment Arm |
| BupivacainPatients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery. | Drug | Bupivacaine Control Arm |
| EpinephrineAlso: AdrenalinPatients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm. | Drug | Bupivacaine Control Arm, LB Treatment Arm |
Primary outcome
Visual Analog Pain Scores
Time frame: on Day 1 to Day 5 after surgery
Pain scores at hip and jaw sites. Pain is rated on a 0 to 10 scale with 0 representing no pain and 10 representing agonizing pain with unbearable distress. A lower score is ideal for improved pain management.
Opioid Use
Time frame: on Day 1 to Day 5 after surgery
Opioid use in amount and frequency
PROMIS Pediatric Mobility Questionnaire
Time frame: on Day 1 to Day 5 after surgery
The patient will log activity level using the Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Mobility scale. The categorical answers to the questions are the minimum value "not able to do", "with a lot of trouble", "with some trouble", "with a little trouble", and the maximum value "with no trouble." Therefore a higher amount of reported with no trouble categorical answers would represent improved mobility.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 32324672Chughtai M, Sultan AA, Hudson B, Goodwin RC, Seif J, Khlopas A, Bena J, Jin Y, Gurd DP, Kuivila TE, Ballock RT. Liposomal Bupivacaine Is Both Safe and Effective in Controlling Postoperative Pain After Spinal Surgery in Children: A Controlled Cohort Study. Clin Spine Surg. 2020 Dec;33(10):E533-E538. doi: 10.1097/BSD.0000000000000996.
- Background: PubMed 32195834Crowley JS, McLean P, Gabriel RA, Cronin B, Hsieh S, Englar K, Said E, Lance S, Gosman A. The Association of Liposomal Bupivacaine on Opioid Consumption in the Pediatric Alveolar Cleft Population. J Craniofac Surg. 2020 Jun;31(4):1078-1081. doi: 10.1097/SCS.0000000000006310.
- Background: PubMed 34183559Flowers T, Winters R. Postoperative pain management in pediatric cleft lip and palate repair. Curr Opin Otolaryngol Head Neck Surg. 2021 Aug 1;29(4):294-298. doi: 10.1097/MOO.0000000000000719.
- Background: PubMed 31648962Patel RA, Jablonka EM, Rustad KC, Pridgen BC, Sorice-Virk SS, Borrelli MR, Khosla RK, Lorenz HP, Momeni A, Wan DC. Retrospective cohort-based comparison of intraoperative liposomal bupivacaine versus bupivacaine for donor site iliac crest analgesia during alveolar bone grafting. J Plast Reconstr Aesthet Surg. 2019 Dec;72(12):2056-2063. doi: 10.1016/j.bjps.2019.09.026. Epub 2019 Oct 2.
- Individual participant dataSharing planned: No
Related trials for Cleft Lip and Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Enrolling by invitation
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
Cleft Palate +/- Lip
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.
Chad A. Purnell, MD principal investigator
Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal Bupivacaine, Bupivacain and Epinephrine in people with Cleft Lip and Palate, run by Kerry O'Rourke 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chad A. Purnell, MD ((724)-433-1645, cpurnell@shrinenet.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Pain Scores (time frame: on Day 1 to Day 5 after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284434, which also lists 4 linked publications.
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 3 Jul 2024.