Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

NCT06284434 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CHI2311
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Palate

Keywords

cleft lip; cleft palate; alveolar bone graft; pain management; liposomal bupivacaine

Outcome Measures

Primary Outcomes (3)

• 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

• Opioid Use

  Opioid use in amount and frequency

  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.

  on Day 1 to Day 5 after surgery

Study Arms (2)

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.

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).

Drug: Bupivacain; Drug: Epinephrine

Interventions

Liposomal Bupivacaine DRUG

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

Also known as: EXPAREL

LB Treatment Arm

Bupivacain DRUG

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

Bupivacaine Control Arm

Epinephrine DRUG

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

Also known as: Adrenalin

Bupivacaine Control Arm; LB Treatment Arm

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kerry O'Rourke: lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

Shriners Children's Chicago

Chicago, Illinois, 60707, United States

RECRUITING

Related 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.

  PMID: 32324672 BACKGROUND

• 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.

  PMID: 32195834 BACKGROUND

• 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.

  PMID: 34183559 BACKGROUND

• 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.

  PMID: 31648962 BACKGROUND

MeSH Terms

Conditions

Cleft Lip; Cleft Palate; Agnosia

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Chad A. Purnell, MD

  Shriners Hospitals for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chad A. Purnell, MD

CONTACT

(724)-433-1645; cpurnell@shrinenet.org

Benjamin M. Smith, MS

CONTACT

(773) 385-5865; BenjaminM.Smith@shrinenet.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Surgeons and patients will be unaware of which cohort the subject will be randomized to be part of. The pharmacist, anesthesiologist, and research coordinator may all be aware of which drug is administered.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical research coordinator

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 29, 2024
• Study Start: April 24, 2024
• Primary Completion: April 24, 2026
• Study Completion: April 24, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)