Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Cleft Lip and Palate Clinical Trial

Official title:

Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06284434
• Other study ID #: CHI2311
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 24, 2024
• Est. completion date: April 24, 2026

Study information

• Verified date: April 2024
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 24, 2026
• Est. primary completion date: April 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Drug:
• Liposomal Bupivacaine
Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.
• Bupivacain
Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.
• Epinephrine
Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.

Locations

Country	Name	City	State
United States	Shriners Children's Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Kerry O'Rourke	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	on Day 1 to Day 5 after surgery
Primary	Opioid Use	Opioid use in amount and frequency	on Day 1 to Day 5 after surgery
Primary	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.	on Day 1 to Day 5 after surgery

External Links

•   EXPAREL prescribing information