Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol Injection | Drug | 25mg Propofol administered by injection |
| |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Patients with lumbar stenosis to be decompressed over 1-3 segments
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Miller, MAS | Contact | 650-725-7984 | sarahmi@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Todd Alamin, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Surgery Center/Stanford Spine Clinic | Recruiting | Redwood City | California | 94063 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| D008012 | Lidocaine |
| D007267 | Injections |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lidocaine Hydrochloride, Injectable |
| Drug |
Licocaine administered locally via injection. |
|
| Stanford Outpatient surgery center | Recruiting | Redwood City | California | 94608 | United States |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |