Clinical trial NCT06284434: Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
Official title: Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cleft Lip and Palate
Keywords: cleft lip
cleft palate
alveolar bone graft
pain management
liposomal bupivacaine
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2024-02-29
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analog Pain Scores
timeFrame: on Day 1 to Day 5 after surgery
measure: Opioid Use
timeFrame: on Day 1 to Day 5 after surgery
measure: PROMIS Pediatric Mobility Questionnaire
timeFrame: on Day 1 to Day 5 after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shriners Children's Chicago
state: Illinois
Study officials:
affiliation: Shriners Hospitals for Children
name: Chad A. Purnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Crowley 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.
citation: Flowers 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.
citation: Patel 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.