drugset / Trial / NCT04990804
Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery
Phase 4
Terminated
8 enrolled
Vanderbilt University Medical Center
Cervical Spine Research Society · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients undergoing 1-3 level Anterior Cervical Discectomy and Fusion (ACDF) at the levels between C2 and T1 will be enrolled into this randomized prospective study. All patients enrolled in this study will undergo a trial of non-surgical treatment prior to the recommendation for surgery. After enrollment, patients will be randomized utilizing a block randomization strategy to one of two treatment groups - a standard opioid-containing postoperative pain regimen versus a non-opioid postoperative pain regimen. Postoperative outcomes will be assessed.
Timeline
- Start
- 2021-08-01
- Primary completion
- 2022-02-01
- Completion
- 2022-02-01
Outcome
Outcome not reported
Stopped: “Limitations of the prospective study design revealed that a retrospective study design would be better suited.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1000 mg | — |
| Subject | Hydrocodone/Acetaminophen | Unknown | — | — |
| Subject | Ketorolac | Other / unclassified | 10 mg | — |
| Subject | Oxycodone/Acetaminophen | Unknown | — | — |
| Background | Famotidine | Other / unclassified | 20 mg | — |
| Background | Gabapentin | Unknown | 300 mg | — |
| Background | Ibuprofen | Small molecule | 800 mg | — |
| Background | Metaxalone | Small molecule | 800 mg | — |
| Background | Methocarbamol | Small molecule | 750 mg | — |
| Background | Naproxen | Small molecule | 500 mg | — |
| Background | Omeprazole | Other / unclassified | 20 mg | — |
| Background | Pregabalin | Small molecule | 75 mg | — |
| Background | Tizanidine | Small molecule | 2 mg | — |
| Background | Tizanidine | Small molecule | 6 mg | — |
| Background | cyclobenzaprine | Unknown | 5 mg | — |
| Background | cyclobenzaprine | Unknown | 10 mg | — |