Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Study Overview
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Brief Summary
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Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.

Detailed Description
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100 Patients ages 40-95 with lumbar stenosis to be decompressed are randomized to undergo the procedure with either general anesthesia or local anesthetic with MAC. Participants will be randomized to either group 1 General anesthesia or group 2 Local + MAC anesthetic group. Group 1: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing. Group 2: Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed

Official Title
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Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Drug: Propofol Injection
* Drug: Lidocaine Hydrochloride, Injectable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with lumbar stenosis to be decompressed over 1-3 segments Ages 40-95 Appropriate for general anesthesia Exclusion Criteria: Planned significant nerve root retraction Previous fusion operation Unable to comply with follow up Patients with daily morphine equivalents or more 100mg Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components. Patients with allergies to eggs, egg products, soybeans or soy products.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia<br>Patients under this group will be undergoing lumbar decompression surgery with general anesthesia: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing. | Drug: Propofol Injection<br>* 25mg Propofol administered by injection<br>|
| Active Comparator: Monitored Anesthetic Care (MAC)/Local<br>Patients under this group wil be undergoing limbar decompression surgery with Monitored Anesthetic care, (MAC)/Local. Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed. | Drug: Lidocaine Hydrochloride, Injectable<br>* Licocaine administered locally via injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry Disability Index (ODI) score | Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability. | Basline through year 2 | 
| Change in patient reported pain | Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain. | Basline through year 2 |