Cutaneous Administration of Local Anesthetic for Spine Injection Procedures
2 other identifiers
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJune 6, 2012
June 1, 2012
2.2 years
September 19, 2008
June 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Pain related to cutaneous anesthesia method
At the time of the injection
Study Arms (3)
Traditional Technique
ACTIVE COMPARATORLocal anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues).
Alternative Technique
EXPERIMENTALLocal 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).
No Anesthetic
NO INTERVENTIONNo local anesthetic is used.
Interventions
Local anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues).
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- University of Michigancollaborator
Study Sites (1)
Stanford Univiersity
Redwood City, California, 94063, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew W Smuck
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 22, 2008
Study Start
June 1, 2009
Primary Completion
August 1, 2011
Study Completion
September 1, 2011
Last Updated
June 6, 2012
Record last verified: 2012-06