Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Early Phase 1

Recruiting

• Conditions: Lumbar Spinal Stenosis
• Interventions: Drug: Lidocaine Hydrochloride, Injectable; Drug: Propofol Injection

• Registration Number: NCT04992572
• Lead Sponsor: Stanford University

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-05
• Study Start: 2021-12-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-10
• Primary Completion: 2024-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with lumbar stenosis to be decompressed over 1-3 segments

• Ages 40-95
• Appropriate for general anesthesia

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitored Anesthetic Care (MAC)/Local	Lidocaine Hydrochloride, Injectable	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.
General anesthesia	Propofol Injection	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.

Primary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index (ODI) score	Basline through year 2	Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.
Change in patient reported pain	Basline through year 2	Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.

Trial Locations

Locations (2)

Susmita Chatterjee; 🇺🇸 Union City, California, United States

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