Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992572
• Other study ID #: 61453
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 1, 2021
• Est. completion date: December 2028

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2028
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
United States	Outpatient Surgery Center/Stanford Spine Clinic	Redwood City	California
United States	Susmita Chatterjee	Union City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Local anesthetic with sedation is a viable alternative to general anesthesia for lumbar spinal decompressions: A retrospective cohort feasibility study and short-term analysis of outcomes