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Cutaneous Administration of Local Anesthetic for Spine Injection Procedures

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ClinicalTrials.gov Identifier: NCT00756301
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : June 6, 2012
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Stanford University

Brief Summary:

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 or disease Intervention/treatment Phase
Spinal Diseases Other: Lidocaine local anesthesia- Alternative Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Cutaneous Administration of Local Anesthetic for Spine Injection Procedures: A Prospective Randomized Controlled Trial of Patient Preferred Method
Study Start Date : June 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Pain related to cutaneous anesthesia method [ Time Frame: At the time of the injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00756301     History of Changes
Other Study ID Numbers: HUM00002610
16893
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

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