We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 21, 2021
First Posted Date  ICMJE August 5, 2021
Last Update Posted Date May 10, 2022
Actual Study Start Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2021)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Local/ MAC Anesthesia in Lumbar Decompression
Official Title  ICMJE Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Spinal Stenosis
Intervention  ICMJE
  • Drug: Propofol Injection
    25mg Propofol administered by injection
  • Drug: Lidocaine Hydrochloride, Injectable
    Licocaine administered locally via injection.
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Propofol 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.

    Intervention: Drug: Lidocaine Hydrochloride, Injectable
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2028
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04992572
Other Study ID Numbers  ICMJE 61453
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Todd Alamin, Stanford University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stanford University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Todd Alamin, MD Stanford University
PRS Account Stanford University
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP