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Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Primary Purpose

Lumbar Spinal Stenosis

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Propofol Injection

Lidocaine Hydrochloride, Injectable

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outpatient Surgery Center/Stanford Spine ClinicRecruiting
Susmita ChatterjeeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

General anesthesia

Monitored Anesthetic Care (MAC)/Local

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Oswestry Disability Index (ODI) score

Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.

Change in patient reported pain

Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.

Secondary Outcome Measures

Full Information

NCT ID

NCT04992572

First Posted

July 21, 2021

Last Updated

May 5, 2022

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04992572

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spinal Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

General anesthesia

Arm Type

Active Comparator

Arm Description

Arm Title

Monitored Anesthetic Care (MAC)/Local

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Propofol Injection

Intervention Description

25mg Propofol administered by injection

Intervention Type

Drug

Intervention Name(s)

Lidocaine Hydrochloride, Injectable

Intervention Description

Licocaine administered locally via injection.

Primary Outcome Measure Information:

Title

Change in Oswestry Disability Index (ODI) score

Description

Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.

Time Frame

Basline through year 2

Title

Change in patient reported pain

Description

Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.

Time Frame

Basline through year 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Todd Alamin, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Outpatient Surgery Center/Stanford Spine Clinic

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susmita Chatterjee, MS/CCRP

Phone

650-497-9271

susmitac@stanford.edu

Facility Name

Susmita Chatterjee

City

Union City

State/Province

California

ZIP/Postal Code

94587

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susmita Chatterjee, MS/CCRP

Phone

650-497-9271

susmitac@stanford.edu

First Name & Middle Initial & Last Name & Degree

Agnes Ith, MD

Phone

6504979271

mith@stanford.edu

First Name & Middle Initial & Last Name & Degree

Todd F Alamin, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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