Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study
Stopped early · Phase 4
Conditions studied: Single Level Lumbar Decompression and Fusion Spine Surgery
In brief
The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to usual analgsic care.
Key facts
- Study ID
- NCT02202369
- Run by
- OrthoCarolina Research Institute, Inc.
- People needed
- 50
- Starts
- 2015-06-25
- Expected to finish
- 2020-09-12
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects undergoing a single level lumbar decompression and fusion
- > 18 years of age and < 70 years of age
- The subject is willing and able to understand, sign and date the study specific patient informed consent and HIPAA authorization to volunteer participation in the study
You may not qualify if…
- Patients with liver disease (documented liver function test abnormality)
- Patients with renal disease (documented glomerular filtration rate < 60mL/min/1.73m2)
- Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.
- Patients with active alcohol dependence
- Patients with active illicit drug dependence
- Patients < 18 years of age and >70 years of age
- Patients allergic to any medication given in either arm (list medications)
- Patients who have a seizure disorder
Where it is running
- OrthoCarolina — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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