Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 95 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04992572
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stanford University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Todd Alamin, MD
Principal Investigator Affiliation	Stanford University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lumbar Spinal Stenosis

Additional Details

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

Arms & Interventions

Arms

Active Comparator: 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.

Active Comparator: 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.

Interventions

Drug: - Propofol Injection

25mg Propofol administered by injection

Drug: - Lidocaine Hydrochloride, Injectable

Licocaine administered locally via injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Redwood City, California

Status

Recruiting

Address

Outpatient Surgery Center/Stanford Spine Clinic

Redwood City, California, 94063

Site Contact

Susmita Chatterjee, MS/CCRP

[email protected]

650-497-9271

Susmita Chatterjee, Union City, California