Lumbar Spinal StenosisEarly Phase 1NCT04992572
Study Comparing Local/ MAC Anesthesia in Lumbar Decompression
A Early Phase 1 study testing Propofol Injection and Lidocaine Hydrochloride, Injectable in people with Lumbar Spinal Stenosis, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Propofol Injection and Lidocaine Hydrochloride, Injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2021to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lumbar stenosis to be decompressed over 1-3 segments
- Ages 40-95
- Appropriate for general anesthesia
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Outpatient Surgery Center/Stanford Spine Clinic
Redwood City, California, 94063
Sarah Miller, MS, 650-725-7984, Sarahmi@stanford.edu
- Recruiting
Stanford Outpatient surgery center
Redwood City, California, 94608
Susmita Chatterjee, MS/CCRP, 6504979271, susmitac@stanford.edu
Agnes Ith, MD, 6504979271, mith@stanford.edu
About this study
Official title: Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
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.
Read the 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
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Propofol Injection, Lidocaine Hydrochloride, Injectable
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol InjectionDrug
25mg Propofol administered by injection
Lidocaine Hydrochloride, InjectableDrug
Licocaine administered locally via injection.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | 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. Receives: Drug: Propofol Injection |
| Monitored Anesthetic Care (MAC)/Local | Active comparator | 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. Receives: Drug: Lidocaine Hydrochloride, Injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index (ODI) score
Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.
Measured: 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.
Measured: Basline through year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Alamin, Stanford University
- Investigators
- Todd Alamin, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992572
- Sponsor's protocol ID
- 61453
- Status last verified
- Mar 2026
- First submitted
- 21 Jul 2021
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
- ClinicalTrials.gov ID
- NCT04992572
- Acronym / sponsor ID
- 61453
- Conditions
- Lumbar Spinal Stenosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | Drug: Propofol InjectionPatients 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. |
| Monitored Anesthetic Care (MAC)/Local | Active comparator | Drug: Lidocaine Hydrochloride, InjectablePatients 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. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with lumbar stenosis to be decompressed over 1-3 segments
- Ages 40-95
- Appropriate for general anesthesia
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol Injection25mg Propofol administered by injection | Drug | General anesthesia |
| Lidocaine Hydrochloride, InjectableLicocaine administered locally via injection. | Drug | Monitored Anesthetic Care (MAC)/Local |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Todd Alamin, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Propofol Injection and Lidocaine Hydrochloride, Injectable in people with Lumbar Spinal Stenosis, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Miller, MAS (650-725-7984, sarahmi@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) score (time frame: Basline through year 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.