Liposomal Bupivacaine Use in Alveolar Bone Graft Patients

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.

Timeline

Start

2024-04-24

Primary completion

2026-04-24

Completion

2026-04-24

Publications

• Background 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.
• 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.
• 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.
• 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.

Drugs

Indications