Spinal DiseasesNCT00756301
Cutaneous Administration of Local Anesthetic for Spine Injection Procedures
A study testing Lidocaine local anesthesia- Alternative in people with Spinal Diseases, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Diseases
- What is being tested?
- Lidocaine local anesthesia- Alternative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Univiersity
Redwood City, California, 94063
About this study
Official title: Cutaneous Administration of Local Anesthetic for Spine Injection Procedures: A Prospective Randomized Controlled Trial of Patient Preferred Method
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.
Read the 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:
- 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.
- 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.
- No local anesthetic is used.
- 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.
- 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.
- Complete the designated anesthesia technique.
- 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.
- Finally, we ask the patient to rate on a 10 point verbal analog scale the amount of pain they experienced during this time.
- 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.
- Conditions
- Spinal Diseases
- Being tested
- Lidocaine local anesthesia- Alternative
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine local anesthesia- AlternativeOther
Local anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues).
| Study group | Role | What they receive |
|---|---|---|
| Traditional Technique | Active comparator | Local anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues). Receives: Other: Lidocaine local anesthesia- Alternative |
| Alternative Technique | Experimental | 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). Receives: Other: Lidocaine local anesthesia- Alternative |
| No Anesthetic | No intervention | No local anesthetic is used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain related to cutaneous anesthesia method
Measured: At the time of the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Matthew W Smuck, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756301
- Sponsor's protocol ID
- HUM00002610
- Other IDs
- 16893
- Status last verified
- Jun 2012
- First submitted
- 19 Sep 2008
- Last updated
- 6 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Administration of Local Anesthetic for Spine Injection Procedures: A Prospective Randomized Controlled Trial of Patient Preferred Method
- ClinicalTrials.gov ID
- NCT00756301
- Acronym / sponsor ID
- HUM00002610
- Conditions
- Spinal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Jun 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- No local anesthetic is used.
- 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.
- 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.
- Complete the designated anesthesia technique.
- 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.
- Finally, we ask the patient to rate on a 10 point verbal analog scale the amount of pain they experienced during this time.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Technique | Active comparator | Other: Lidocaine local anesthesia- AlternativeLocal anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues). |
| Alternative Technique | Experimental | Other: Lidocaine local anesthesia- AlternativeLocal 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 intervention | –No local anesthetic is used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine local anesthesia- AlternativeLocal anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues). | Other | Alternative Technique, Traditional Technique |
Primary outcome
Pain related to cutaneous anesthesia method
Time frame: At the time of the injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew W Smuck principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine local anesthesia- Alternative in people with Spinal Diseases, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain related to cutaneous anesthesia method (time frame: At the time of the injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.