Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in Oswestry Disability Index (ODI) score
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
General anesthesia
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.
Intervention: Propofol Injection (Drug)
Monitored Anesthetic Care (MAC)/Local
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.
Intervention: Lidocaine Hydrochloride, Injectable (Drug)
Outcomes
Primary Outcomes
Change in Oswestry Disability Index (ODI) score
Time Frame: Basline through year 2
Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.
Change in patient reported pain
Time Frame: Basline through year 2
Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.
Secondary Outcomes
No secondary outcomes reported
Investigators
Todd Alamin
Professor
Stanford University