An Early Phase 1 interventional study of Propofol Injection and Lidocaine Hydrochloride, Injectable in Lumbar Spinal Stenosis, sponsored by Stanford University. Recruiting at 2 sites in United States. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Stanford University · Early Phase 1, Interventional, and Treatment
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.
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
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Patients with lumbar stenosis to be decompressed over 1-3 segments
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
25mg Propofol administered by injection
Licocaine administered locally via injection.
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 2
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 2
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Dec 2026, 60 months after the start.
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Studies of the drugs tested here: Propofol · Lidocaine