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Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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ClinicalTrials.gov Identifier: NCT04992572
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Todd Alamin, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Drug: Propofol Injection Drug: Lidocaine Hydrochloride, Injectable Early Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
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.

 Drug: Propofol Injection
25mg Propofol administered by injection
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.

 Drug: Lidocaine Hydrochloride, Injectable
Licocaine administered locally via injection.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04992572


Locations
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United States, California
Outpatient Surgery Center/Stanford Spine Clinic Recruiting
Redwood City, California, United States, 94063
Contact: Susmita Chatterjee, MS/CCRP    650-497-9271    susmitac@stanford.edu   
Susmita Chatterjee Recruiting
Union City, California, United States, 94587
Contact: Susmita Chatterjee, MS/CCRP    650-497-9271    susmitac@stanford.edu   
Contact: Agnes Ith, MD    6504979271    mith@stanford.edu   
Principal Investigator: Todd F Alamin, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Todd Alamin, MD Stanford University
More Information
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Responsible Party: Todd Alamin, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04992572    
Other Study ID Numbers: 61453
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Lidocaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General