Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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

Tracking Information

• First Submitted Date: July 21, 2021
• First Posted Date: August 5, 2021
• Last Update Posted Date: May 10, 2022
• Actual Study Start Date: December 1, 2021
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Comparing Local/ MAC Anesthesia in Lumbar Decompression
• Official Title: 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lumbar Spinal Stenosis

Intervention

• Drug: Propofol Injection
  25mg Propofol administered by injection
• Drug: Lidocaine Hydrochloride, Injectable
  Licocaine administered locally via injection.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 4, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2028
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 95 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04992572
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Todd Alamin, Stanford University
• Original Responsible Party: Same as current
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Todd Alamin, MD; Stanford University

• PRS Account: Stanford University
• Verification Date: May 2022