Efficacy of Ultrasound Guided Nerve BlockNCT02383615
Comparison of Two Different Ultrasound Guided Techniques for Saphenous Nerve Block
A study testing Saphenous nerve block in people with Efficacy of Ultrasound Guided Nerve Block, run by University of Iowa.
Trial summary
Saphenous nerve blocks can be technically challenging. Recently described ultrasound techniques have improved the success rate of saphenous nerve blocks, but randomized controlled trials comparing these techniques are lacking. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Efficacy of Ultrasound Guided Nerve Block
- What is being tested?
- Saphenous nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Aug 2014
- 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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective foot and ankle surgery receiving saphenous nerve block for pain management
- American Society of Anesthesiologists Physical Status (ASA PS) scores 1, 2 and 3
Who cannot join
- Neuropathy
- Allergy to local anesthetics
- ASA PS scores 4 and 5
About this study
Official title: A Comparison of Two Different Ultrasound-Guided Approaches to the Saphenous Nerve Block - Adductor Canal vs. Distal Trans-sartorial: A Prospective, Randomized, Blinded, Non-Inferiority Trial
Saphenous nerve blocks can be technically challenging. Recently described ultrasound techniques have improved the success rate of saphenous nerve blocks, but randomized controlled trials comparing these techniques are lacking. The investigators compared two common ultrasound guided approach for saphenous nerve block: saphenous nerve block at the adductor canal (ACSNB) vs. block by the distal trans-sartorial (DTSNB) approach.
Read the detailed description
Patients received either ACSNB or DTSNB in this prospective randomized, blinded, non-inferiority clinical trial. The primary objective was to show the non-inferiority of ACSNB to DTSNB in terms of block success. Secondary outcome measures were time required to perform the block, time to onset of successful block, and the visibility of the nerve using ultrasound.
Sample size calculation: To address the primary objective of the study--to show non-inferiority of the ACSNB to DTSNB in terms of success as defined above- the investigators used the test of non-inferiority of two proportions. DTSNB is the primary technique of doing saphenous nerve block at the investigators' institution. From chart review of the electronic records from 2011 to 2012, the investigators found there was a 3% incidence of rescue blocks among saphenous nerve blocks (19 out of 667 blocks) at their institution. This assumed a success rate of approximately 97%. A study by Saranteas et al reported a success rate of 95.6% in healthy volunteers undergoing saphenous nerve block just after it exited from the adductor canal. Based on these two observations, the investigators expected the success rate of DTSNB to be 95%. To establish the non-inferiority of ACSNB to DTSNB, the investigators pre-determined that the success rate of ACSNB should not be lower than 85% (the expected difference in proportions should be less than (95% - 85%) 10%). Under these assumptions, to achieve 80% power, with a one-sided type I error rate of 0.05, the study needed 59 subjects per group; 118 patients total. 120 patients were enrolled for this study., randomized to receive either ACSNB (n=58) or DTSNB (n=62).To show the non-inferiority of the ACSNB to DTSNB, the upper 95% confidence bound of the success rates (πDTSNB - πACSNB) should be less than 10%.
The normality of continuous variables was tested by the Shapiro Wilk's test. Based on the normality assumption, two independent samples t-test or Mann-Whitney U test was performed for continuous variables. Chi-square test or Fisher's exact test was performed for categorical variables.
- Being tested
- Saphenous nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saphenous nerve blockProcedure or surgery
Ultrasound guided saphenous nerve blocks with 0.5% Ropivacaine for patients undergoing elective foot and ankle surgery for post-operative pain relief.
| Study group | Role | What they receive |
|---|---|---|
| DTSNB | Active comparator | Distal transsartorial saphenous nerve block Receives: Procedure: Saphenous nerve block |
| ACSNB | Active comparator | Adductor canal saphenous nerve block Receives: Procedure: Saphenous nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the saphenous nerve block
Loss of pin prick sensation to 2 of the 3 pre-defined areas of saphenous nerve distribution in the operative leg after performing the nerve block.
Measured: 30 minutes
Secondary outcomes (3)
Speed of onset of saphenous nerve block
Time taken for loss of pinprick sensation in 2 of the 3 pre-defined areas of saphenous nerve distribution in the leg after performing the nerve block.
Measured: 30 minutes
Nerve visibility under ultrasound
Nerve visibility under ultrasound guidance, graded as 1 (clearly visible) to 3 (not visible even after local anesthetic infiltration)
Measured: 30 minutes
Time taken to perform block
Time taken from skin infiltration of local anesthetic to the nerve block needle removed from patient
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Ultrasound Guided Nerve BlockStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil A Marian, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383615
- Sponsor's protocol ID
- 201302730
- Status last verified
- Mar 2015
- First submitted
- 24 Feb 2015
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Ultrasound-Guided Approaches to the Saphenous Nerve Block - Adductor Canal vs. Distal Trans-sartorial: A Prospective, Randomized, Blinded, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT02383615
- Acronym / sponsor ID
- 201302730
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Mar 2015 (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.
Saphenous nerve blocks can be technically challenging. Recently described ultrasound techniques have improved the success rate of saphenous nerve blocks, but randomized controlled trials comparing these techniques are lacking. The investigators compared two common ultrasound guided approach for saphenous nerve block: saphenous nerve block at the adductor canal (ACSNB) vs. block by the distal trans-sartorial (DTSNB) approach.
Detailed description
Patients received either ACSNB or DTSNB in this prospective randomized, blinded, non-inferiority clinical trial. The primary objective was to show the non-inferiority of ACSNB to DTSNB in terms of block success. Secondary outcome measures were time required to perform the block, time to onset of successful block, and the visibility of the nerve using ultrasound.
Sample size calculation: To address the primary objective of the study--to show non-inferiority of the ACSNB to DTSNB in terms of success as defined above- the investigators used the test of non-inferiority of two proportions. DTSNB is the primary technique of doing saphenous nerve block at the investigators' institution. From chart review of the electronic records from 2011 to 2012, the investigators found there was a 3% incidence of rescue blocks among saphenous nerve blocks (19 out of 667 blocks) at their institution. This assumed a success rate of approximately 97%. A study by Saranteas et al reported a success rate of 95.6% in healthy volunteers undergoing saphenous nerve block just after it exited from the adductor canal. Based on these two observations, the investigators expected the success rate of DTSNB to be 95%. To establish the non-inferiority of ACSNB to DTSNB, the investigators pre-determined that the success rate of ACSNB should not be lower than 85% (the expected difference in proportions should be less than (95% - 85%) 10%). Under these assumptions, to achieve 80% power, with a one-sided type I error rate of 0.05, the study needed 59 subjects per group; 118 patients total. 120 patients were enrolled for this study., randomized to receive either ACSNB (n=58) or DTSNB (n=62).To show the non-inferiority of the ACSNB to DTSNB, the upper 95% confidence bound of the success rates (πDTSNB - πACSNB) should be less than 10%.
The normality of continuous variables was tested by the Shapiro Wilk's test. Based on the normality assumption, two independent samples t-test or Mann-Whitney U test was performed for continuous variables. Chi-square test or Fisher's exact test was performed for categorical variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTSNB | Active comparator | Procedure: Saphenous nerve blockDistal transsartorial saphenous nerve block |
| ACSNB | Active comparator | Procedure: Saphenous nerve blockAdductor canal saphenous nerve block |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective foot and ankle surgery receiving saphenous nerve block for pain management
- American Society of Anesthesiologists Physical Status (ASA PS) scores 1, 2 and 3
Key exclusion criteria (3 listed)
- Neuropathy
- Allergy to local anesthetics
- ASA PS scores 4 and 5
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 |
|---|---|---|
| Saphenous nerve blockUltrasound guided saphenous nerve blocks with 0.5% Ropivacaine for patients undergoing elective foot and ankle surgery for post-operative pain relief. | Procedure or surgery | ACSNB, DTSNB |
Primary outcome
Success rate of the saphenous nerve block
Time frame: 30 minutes
Loss of pin prick sensation to 2 of the 3 pre-defined areas of saphenous nerve distribution in the operative leg after performing the nerve block.
3 secondary outcomes
Speed of onset of saphenous nerve block
Time frame: 30 minutes
Nerve visibility under ultrasound
Time frame: 30 minutes
Time taken to perform block
Time frame: 30 minutes
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 9 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Saphenous nerve block in people with Efficacy of Ultrasound Guided Nerve Block, run by University of Iowa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Success rate of the saphenous nerve block (time frame: 30 minutes). 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 9 Mar 2015.