NCT04992572

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Propofol Injection	25mg Propofol administered by injection
DRUG	Lidocaine Hydrochloride, Injectable	Licocaine administered locally via injection.

Timeline

• Start date: 2021-12-01
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2021-08-05
• Last updated: 2026-03-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study