drugset / Trial / NCT06561035
Reduce Opiate Exposure With ACL Surgery
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).
Timeline
- Start
- 2024-09-01
- Primary completion
- 2027-12
- Completion
- 2028-03
Publications
- Results Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid prescriptions in 2009. JAMA. 2011 Apr 6;305(13):1299-301. doi: 10.1001/jama.2011.401. No abstract available.
- Results Shah A, Hayes CJ, Martin BC. Factors Influencing Long-Term Opioid Use Among Opioid Naive Patients: An Examination of Initial Prescription Characteristics and Pain Etiologies. J Pain. 2017 Nov;18(11):1374-1383. doi: 10.1016/j.jpain.2017.06.010. Epub 2017 Jul 13.
- Results NO PAin Investigators; Gazendam A, Ekhtiari S, Horner NS, Simunovic N, Khan M, de Sa DL, Madden K, Ayeni OR. Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial. JAMA. 2022 Oct 4;328(13):1326-1335. doi: 10.1001/jama.2022.16844.
- Results Jones CA, Throckmorton TW, Murphy J, Eason RR, Joyce M, Bernholt DL, Azar FM, Brolin TJ. Opioid-sparing pain management protocol after shoulder arthroplasty results in less opioid consumption and higher satisfaction: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2022 Oct;31(10):2057-2065. doi: 10.1016/j.jse.2022.05.029. Epub 2022 Jul 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | 75 mg | — |
| Subject | Medrol Dosepak | Unknown | — | — |
| Background | Acetaminophen | Small molecule | 1000 mg | — |
| Background | Aspirin | Small molecule | — | — |
| Background | Docusate Sodium | Unknown | — | — |
| Background | Gabapentin | Unknown | 100 mg | — |
| Background | Methocarbamol | Small molecule | 750 mg | — |
| Background | Oxycodone | Other / unclassified | 5 mg | — |
| Background | Promethazine | Small molecule | 25 mg | — |
| Background | Sennosides | Unknown | — | — |
| Background | Tramadol | Other / unclassified | 50 mg | — |
Indications
No indication recorded.