drugset / Trial / NCT03586934
Multimodal Analgesia in Shoulder Arthroplasty
RandomizedParallel-groupDouble-blindTreatment
Summary
Opioid medications are associated with many side effects and the risk of abuse or overdose. Orthopaedic surgeons are currently investigating ways to control pain after surgery while limiting the amount of opioid medications prescribed. One way to reduce the amount of opioid medications prescribed, and potentially avoid opioid-associated adverse events, is to use multiple non-opioid medications and anesthetic drugs before surgery, during surgery, and after surgery. This study aims to evaluate a protocol with non-opioid pain medications to reduce the need for opioid medication after shoulder surgery.
Timeline
- Start
- 2018-06-01
- Primary completion
- 2019-06-01
- Completion
- 2019-06-01
Publications
- Background Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614.
- Background Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
- Background Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.
- Background Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.
- Background Moreno MA. Page for patients. The misuse of prescription pain medicine among children and teens. JAMA Pediatr. 2015 May;169(5):512. doi: 10.1001/jamapediatrics.2014.2128. No abstract available.
- Background Della Valle CJ, Dittle E, Moric M, Sporer SM, Buvanendran A. A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty. Clin Orthop Relat Res. 2010 Dec;468(12):3348-54. doi: 10.1007/s11999-010-1491-5. Epub 2010 Jul 29.
- Background Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Randomized Controlled Trial of Interscalene Block Compared with Injectable Liposomal Bupivacaine in Shoulder Arthroplasty. J Bone Joint Surg Am. 2017 Apr 5;99(7):550-556. doi: 10.2106/JBJS.16.00296.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 325 mg | — |
| Subject | Acetaminophen | Small molecule | 500 mg | — |
| Subject | Acetaminophen | Small molecule | 1000 mg | — |
| Subject | Celecoxib | Other / unclassified | 200 mg | — |
| Subject | Celecoxib | Other / unclassified | 400 mg | — |
| Subject | Hydrocodone | Unknown | 5 mg | Oral |
| Subject | Hydrocodone | Unknown | 10 mg | Oral |
| Subject | Ketorolac | Other / unclassified | 15 mg | Intravenous |
| Subject | Meloxicam | Small molecule | 15 mg | Oral |
| Subject | Morphine | Other / unclassified | 1 mg | Intravenous |
| Subject | Morphine | Other / unclassified | 2 mg | Intravenous |
| Subject | Oxycodone | Other / unclassified | 5 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 10 mg | Oral |
| Subject | Tramadol | Other / unclassified | 100 mg | Oral |
| Background | Ropivacaine | Other / unclassified | 30 ml | Other |