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NCT Number: NCT04992572

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Outpatient Surgery Center/Stanford Spine Clinic, Redwood City, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol Injection

Drug

25mg Propofol administered by injection

Lidocaine Hydrochloride, Injectable

Drug

Licocaine administered locally via injection.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Miller, MAS

CONTACT

[email protected]

650-725-7984

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Aug 5, 2021
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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