Status:
SUSPENDED
Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Collaborating Sponsors:
Charlotte Orthopedic Hospital
Conditions:
Single Level Lumbar Decompression and Fusion Spine Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Specific Aim #1: To compare the postoperative pain levels of single level lumbar fusion patients treated with either MMA pain management protocol or standard pain management protocol. Controlling pos...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 25 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2050
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02202369
Start Date
June 25 2015
End Date
December 31 2050
Last Update
April 28 2025
Active Locations (1)
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1
OrthoCarolina
Charlotte, North Carolina, United States, 28207