Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Stanford University

Status and phase: Enrolling; Early Phase 1

Conditions: Lumbar Spinal Stenosis

Treatments: Drug: Lidocaine Hydrochloride, Injectable; Drug: Propofol Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04992572

61453

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

General anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol Injection

Monitored Anesthetic Care (MAC)/Local

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine Hydrochloride, Injectable