Cutaneous Administration of Local Anesthetic for Spine Injection Procedures

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00756301
First received: September 19, 2008
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

Interventional spine procedures are an increasingly popular means of diagnosis and treatment of spine disease. By convention, local anesthetics are used at the beginning of these procedures with the goal of minimizing pain. However, the infiltration of the local anesthetic is painful. This initial painful stimulus can heighten pain awareness and cause anxiety or excessive movement during the procedure.

The purpose of this study is to determine patient discomfort with administration of cutaneous local anesthetic prior to interventional spine procedures compared to no anesthetic administration for different gauge procedural needles. Another purpose is to determine patient discomfort with administration of local anesthetic by traditional technique compared to an alternative technique and to develop a standardized technique and criteria for local anesthetic administration during spine injection procedures that minimizes patient pain, and may help reduce the overall risk of these procedures.

We plan to enroll a total of 200-300 subjects coming to Stanford for symmetric bilateral single injections.


Condition Intervention
Spinal Diseases
Other: Lidocaine local anesthesia- Alternative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Cutaneous Administration of Local Anesthetic for Spine Injection Procedures: A Prospective Randomized Controlled Trial of Patient Preferred Method

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Pain related to cutaneous anesthesia method [ Time Frame: At the time of the injection ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional Technique
Local anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues).
Other: Lidocaine local anesthesia- Alternative
Local anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues).
Experimental: Alternative Technique
Local anesthetic (Lidocaine) injected using an alternative technique (inserting the numbing needle into the deeper tissues first and injecting numbing medication from there up to the skin).
Other: Lidocaine local anesthesia- Alternative
Local anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues).
No Intervention: No Anesthetic
No local anesthetic is used.

Detailed Description:

Any patient referred by their treating physician for symmetric bilateral single injections (for example, bilateral transforaminal epidural injections, bilateral facet injections, or bilateral SI joint injections, etc.) will provide written informed consent before the procedure is conducted.

The contents of the consent forms will be used to explain the study to patients. Patients with pregnancy, coagulopathy, systemic infection, allergy to contrast dye, mentally disabled or those whom are unable to give informed consent will be excluded from the study.

Three different cutaneous local anesthetic techniques will be investigated, hereafter referred to as (a), (b), and (c), and described in detail here:

  1. Local anesthetic injected with a 27-gauge 1.25" needle using traditional technique- formation of a subcutaneous wheal with 0.25cc 1% Lidocaine, then 0.75cc 1% Lidocaine injected along the planned needle trajectory to the hub depth of the 27-gauge needle.
  2. Local anesthetic injected with a 27-gauge 1.25" needle using an alternative technique- needle is immediately inserted in the planned needle trajectory to the hub depth. Then 1cc 1% Lidocaine is injected slowly as the needle is withdrawn to the skin creating a small point wheal at the skin prior to removal of the needle.
  3. No local anesthetic is used.

    1. Patients are randomly assigned to receive one of three possible combinations of anesthetic techniques (one on each side i.e. (a) & (b), (a) &(c), (b)&(c). Randomized assignment will occur on a rotating basis, i.e.; patient #1 will receive (a)&(b), patient #2 will receive (a)&(c), patient #3 will receive (b)&(c), and so on. Regardless of technique (a), (b), or (c), the following four steps are followed.
    2. After the starting point of the procedure is identified, before placement of any needles, we ask the patient to take note of any subsequent discomfort or pain.
    3. Complete the designated anesthesia technique.
    4. Next, place the treatment needle to a depth of 1 inch. Needle size is determined by the injectionist at the time of the procedure, based on what is determined to be best suited for the patient and the procedure from the following quinke point needles: 26-gauge 3.5", 25-gauge 3.5", or 22-gauge 3.5" needle. The same size needle will be used on each side.
    5. Finally, we ask the patient to rate on a 10 point verbal analog scale the amount of pain they experienced during this time.
    6. Repeat steps 2 thru 5 for the second side of the procedure.

All data is collected during the procedure. There will be no follow-up visits after the procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1. Any patients referred by their treating physician for symmetric bilateral single injections (for example, bilateral transforaminal epidural injections, bilateral facet injections, or bilateral SI joint injections, etc.).

2.Ability to give informed consent.

Exclusion Criteria:1.Pregnancy 2.Coagulopathy 3.Systemic infection 4.Allergy to contrast dye 5.Mentally disabled or those whom are unable to give informed consent 6.Those whom are unable to give informed consent in English 7.Prisoner

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756301

Locations
United States, California
Stanford Univiersity
Redwood, California, United States, 94063
Sponsors and Collaborators
Stanford University
University of Michigan
Investigators
Principal Investigator: Matthew W Smuck Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00756301     History of Changes
Other Study ID Numbers: HUM00002610, 16893
Study First Received: September 19, 2008
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Lidocaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014