Sciatic NerveNCT02688439
Ultrasound Guided Sciatic Nerve Block
A study testing Sciatic Nerve block, Leg raised 30° and Distal tourniquet placed on the lower part of the leg in people with Sciatic Nerve, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this study is to determine whether the leg positioning or distal tourniquet used during the injection of local anesthetic may decrease the onset time and prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with popliteal approach. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Sciatic Nerve
- What is being tested?
- Sciatic Nerve block, Leg raised 30° and Distal tourniquet placed on the lower part of the leg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 10 Jul 2019
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective foot surgery under ultrasound guided popliteal sciatic/saphenous block
- American Society of Anesthesiologist physical status 1-3, meaning patients who are either completely or their systemic disease(s), if they have is (are) under control with medications or other means.
- Have capacity to provide informed consent.
Who cannot join
- clinically significant coagulopathy (impaired blood clotting)
- infection at injection site
- allergy to local anesthetics
- severe cardiopulmonary disease (heart and lung disease)
- body mass index >35 kg.m2
- known neuropathies (degenerative, infectious and traumatic peripheral nerve diseases)
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- who are receiving opioids for chronic analgesic therapy at the time of contemplated surgery
- Patients with history of AIDS, tuberculosis, and other infections
- active and/or unstable cardiac, renal, pulmonary and neurologic disorders will be excluded from the study. This includes patients in heart failure having limited exercise ability, end stage renal failure on dialysis treatment, recent stroke etc.
- Vulnerable subjects (children, pregnant subjects, prisoners, mentally impaired) also will not be included in the study.
- Subjects who do not understand or speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Effect of Leg Positioning and Tourniquet Inflation on Onset and Duration of Ultrasound Guided Sciatic Nerve Block After Injection of Local Anesthetic
The primary purpose of this study is to determine whether the leg positioning or distal tourniquet used during the injection of local anesthetic may decrease the onset time and prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with popliteal approach. Patients will be divided randomly into three groups: group 1 will receive sciatic nerve block, with leg kept in a neutral position after anesthesia (control group); group 2 will receive the same anesthesia, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min; and patients in group 3 will receive the same anesthesia, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position
- Conditions
- Sciatic Nerve
- Being tested
- Sciatic Nerve block, Leg raised 30°, Distal tourniquet placed on the lower part of the leg, Leg in a neutral position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic Nerve blockOther
Leg raised 30°Other
Distal tourniquet placed on the lower part of the legOther
Leg in a neutral positionOther
| Study group | Role | What they receive |
|---|---|---|
| Leg in a neutral position | Active comparator | Sciatic nerve block, with leg kept in a neutral position after anesthesia (control group) Receives: Other: Sciatic Nerve block; Other: Leg in a neutral position |
| Leg raised 30° | Experimental | Sciatic nerve block, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min Receives: Other: Sciatic Nerve block; Other: Leg raised 30° |
| Distal tourniquet placed on the lower part of the leg | Experimental | Sciatic nerve block, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position. Receives: Other: Sciatic Nerve block; Other: Distal tourniquet placed on the lower part of the leg; Other: Leg in a neutral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Sensory block by measuring decrease in sensation on the scale of 0 to 5 (0 being no sensation; 5 being most sensation) as compared to the other foot.
Measured: 15 Minutes
Evaluation of motor block evaluated by measuring movement on the scale of 0 to 5 as compared to the other foot.
Measured: 15 Minutes
Level of pain measured on a scale of 0 to 10 (0 being no pain; 10 being most pain) prior to first pain killer
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startMar 2015
- Primary completion29 Dec 2017
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic NerveStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Levon Capan, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688439
- Sponsor's protocol ID
- 14-01327
- Status last verified
- Aug 2019
- First submitted
- 20 Jan 2016
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Leg Positioning and Tourniquet Inflation on Onset and Duration of Ultrasound Guided Sciatic Nerve Block After Injection of Local Anesthetic
- ClinicalTrials.gov ID
- NCT02688439
- Acronym / sponsor ID
- 14-01327
- Conditions
- Sciatic Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 23 Feb 2016 (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.
The primary purpose of this study is to determine whether the leg positioning or distal tourniquet used during the injection of local anesthetic may decrease the onset time and prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with popliteal approach. Patients will be divided randomly into three groups: group 1 will receive sciatic nerve block, with leg kept in a neutral position after anesthesia (control group); group 2 will receive the same anesthesia, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min; and patients in group 3 will receive the same anesthesia, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leg in a neutral position | Active comparator | Other: Sciatic Nerve block, Other: Leg in a neutral positionSciatic nerve block, with leg kept in a neutral position after anesthesia (control group) |
| Leg raised 30° | Experimental | Other: Sciatic Nerve block, Other: Leg raised 30°Sciatic nerve block, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min |
| Distal tourniquet placed on the lower part of the leg | Experimental | Other: Sciatic Nerve block, Other: Distal tourniquet placed on the lower part of the leg, Other: Leg in a neutral positionSciatic nerve block, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective foot surgery under ultrasound guided popliteal sciatic/saphenous block
- American Society of Anesthesiologist physical status 1-3, meaning patients who are either completely or their systemic disease(s), if they have is (are) under control with medications or other means.
- Have capacity to provide informed consent.
Key exclusion criteria (11 listed)
- clinically significant coagulopathy (impaired blood clotting)
- infection at injection site
- allergy to local anesthetics
- severe cardiopulmonary disease (heart and lung disease)
- body mass index >35 kg.m2
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 |
|---|---|---|
| Sciatic Nerve block | Other | Distal tourniquet placed on the lower part of the leg, Leg in a neutral position, Leg raised 30° |
| Leg raised 30° | Other | Leg raised 30° |
| Distal tourniquet placed on the lower part of the leg | Other | Distal tourniquet placed on the lower part of the leg |
| Leg in a neutral position | Other | Distal tourniquet placed on the lower part of the leg, Leg in a neutral position |
Primary outcome
Evaluation of Sensory block by measuring decrease in sensation on the scale of 0 to 5 (0 being no sensation; 5 being most sensation) as compared to the other foot.
Time frame: 15 Minutes
Evaluation of motor block evaluated by measuring movement on the scale of 0 to 5 as compared to the other foot.
Time frame: 15 Minutes
Level of pain measured on a scale of 0 to 10 (0 being no pain; 10 being most pain) prior to first pain killer
Time frame: 15 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 5 Aug 2019.
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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.
Levon Capan, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sciatic Nerve block, Leg raised 30° and Distal tourniquet placed on the lower part of the leg in people with Sciatic Nerve, run by NYU Langone Health 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?
The sponsor lists 3 inclusion and 11 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 5 Aug 2019. 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?
Evaluation of Sensory block by measuring decrease in sensation on the scale of 0 to 5 (0 being no sensation; 5 being most sensation) as compared to the other foot. (time frame: 15 Minutes). The study lists 3 primary outcomes in all. 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 5 Aug 2019.