Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

NCT ID: NCT06284434

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2026-04-24

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.

Conditions

Cleft Lip and Palate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

LB Treatment Arm

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.

Group Type: EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type: DRUG

Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.

Epinephrine

Intervention Type: DRUG

Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.

Bupivacaine Control Arm

Patients on the control arm will follow the current standard of care, which is traditional bupivacaine mixed with epinephrine (1:100,000).

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.

Epinephrine

Intervention Type: DRUG

Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.

Interventions

Liposomal Bupivacaine

Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.

Intervention Type: DRUG

Bupivacain

Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.

Intervention Type: DRUG

Epinephrine

Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.

Intervention Type: DRUG

Other Intervention Names

EXPAREL; Adrenalin

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shriners Hospitals for Children

OTHER

Sponsor Role: collaborator

Kerry O'Rourke

OTHER

Sponsor Role: lead

Responsible Party

Kerry O'Rourke

Clinical research coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chad A. Purnell, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children

Locations

Shriners Children's Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chad A. Purnell, MD

Role: CONTACT

cpurnell@shrinenet.org

(724)-433-1645

Benjamin M. Smith, MS

Role: CONTACT

BenjaminM.Smith@shrinenet.org

(773) 385-5865

Facility Contacts

Benjamin M Smith, MS

Role: primary

benjaminm.smith@shrinenet.org

773-385-5865

References

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.

Reference Type: BACKGROUND

PMID: 32324672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32195834 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34183559 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31648962 (View on PubMed)

Other Identifiers

CHI2311

Identifier Type: -

Identifier Source: org_study_id