SuspendedPhase 4Other

Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study

NCT ID

NCT02202369

Target Enrollment

50 participants

Start Date

2015-06-25

Est. Completion

2050-12-31

About This Study

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.

Conditions Studied

Single Level Lumbar Decompression and Fusion Spine Surgery

Interventions

•Multimodal Analgesia Treatment
•Standard of Care Pain Management Protocol

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility criteria

Inclusion Criteria:

1. Subjects undergoing a single level lumbar decompression and fusion
2. \> 18 years of age and \< 70 years of age
3. 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 Criteria:

1. Patients with liver disease (documented liver function test abnormality)
2. Patients with renal disease (documented glomerular filtration rate \< 60mL/min/1.73m2)
3. Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.
4. Patients with active alcohol dependence
5. Patients with active illicit drug dependence
6. Patients \< 18 years of age and \>70 years of age
7. Patients allergic to any medication given in either arm (list medications)
8. Patients who have a seizure disorder

Study Locations (1)

OrthoCarolina

Charlotte, North Carolina, United States