Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Drug: Propofol Injection; Drug: Lidocaine Hydrochloride, Injectable

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
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Outpatient Surgery Center/Stanford Spine Clinic
      • Contact: Susmita Chatterjee, MS/CCRP; Phone Number: 650-497-9271; Email: susmitac@stanford.edu
    • Union City, California, United States, 94587
      • Recruiting
      • Susmita Chatterjee
      • Contact: Susmita Chatterjee, MS/CCRP; Phone Number: 650-497-9271; Email: susmitac@stanford.edu
      • Contact: Agnes Ith, MD; Phone Number: 6504979271; Email: mith@stanford.edu
      • Principal Investigator: Todd F Alamin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Todd Alamin, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2028

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (ACTUAL): August 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Lidocaine
• Other Study ID Numbers: 61453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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