Study Comparing Local/ MAC Anesthesia in Lumbar Decompression
ConditionLumbar Spinal Stenosis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-95
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 40-95
Appropriate for general anesthesia
Disqualifiers
Planned significant nerve root retraction
Previous fusion operation
Unable to comply with follow up
Patients with daily morphine equivalents or more 100mg
Trial design
Design model
Parallel
Treatments tested in this trial
Propofol Injection
Drug25mg Propofol administered by injection
Lidocaine Hydrochloride, Injectable
DrugLicocaine administered locally via injection.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: General anesthesiaActive comparator 1 intervention
Group B: Monitored Anesthetic Care (MAC)/LocalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Oswestry Disability Index (ODI) score
Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.
Time frame
Basline through year 22
Change in patient reported pain
Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.
Time frame
Basline through year 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov