Foot InjuryNCT02645097
Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
A study testing Saphenous Nerve Block in people with Foot Injury and Ankle Injury, run by Paul J. Juliano, M.D. at 1 site in United States.
Trial summary
This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foot Injury, Ankle Injury
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Upcoming elective foot or ankle surgery
Who cannot join
- Preoperative weakness in knee extension
- Documented neuropathy
- Previous knee surgery
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.
Read the detailed description
This is a prospective, randomized, observer blinded clinical trial comparing motor strength in knee extension between two sets of patients, one receiving a proximal thigh block of the saphenous nerve and one receiving a distal thigh block of the saphenous nerve. The secondary objectives are to compare the pain relief and quality of life of participants in these two groups.
- Conditions
- Foot Injury, Ankle Injury
- Being tested
- Saphenous Nerve Block
- Keywords
- Adult, nerve blocks in foot and ankle surgery, saphenous
- Medical subject headings
- Foot Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saphenous Nerve BlockProcedure or surgery
A nerve block will be performed by the anesthesiologist. The location of the nerve block will be per randomization envelope (proximal vs. distal) and performed just prior to foot or ankle surgical procedures that require a saphenous nerve block
| Study group | Role | What they receive |
|---|---|---|
| Proximal saphenous nerve block | Active comparator | The anesthesiologist will administer a saphenous proximal nerve block if specified in the randomization envelope. Receives: Procedure: Saphenous Nerve Block |
| Distal saphenous nerve block | Active comparator | The anesthesiologist will administer a saphenous distal nerve block if specified in the randomization envelope. Receives: Procedure: Saphenous Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee extensor strength measured in kilograms
Strength of the knee extensors in both treatment arms (distal vs. proximal block) will be tested preoperatively and again 30 minutes after the nerve block by using a hand-held dynamometer measured in kilograms
Measured: change from baseline preoperatively to 30 minutes after nerve block placement
Secondary outcomes (2)
pain level
Pain relief will be measured by review of the medical record for type and amount of pain medications used
Measured: change from baseline preoperatively to two weeks post-operatively
quality of life assessment
PROMIS Global Health Survey will be completed by patients in both treatment arms pre-operatively and again two weeks post-operatively
Measured: change from baseline preoperatively to two weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot InjuryStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul J. Juliano, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul J. Juliano, M.D., Milton S. Hershey Medical Center
- Investigators
- Paul J Juliano, M.D., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645097
- Sponsor's protocol ID
- IRB - 39025
- Status last verified
- Jun 2019
- First submitted
- 28 Dec 2015
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
- ClinicalTrials.gov ID
- NCT02645097
- Acronym / sponsor ID
- IRB - 39025
- Conditions
- Foot Injury, Ankle Injury
- Keywords
- Adult, nerve blocks in foot and ankle surgery, saphenous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Paul J. Juliano, M.D.University, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Jan 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.
This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.
Detailed description
This is a prospective, randomized, observer blinded clinical trial comparing motor strength in knee extension between two sets of patients, one receiving a proximal thigh block of the saphenous nerve and one receiving a distal thigh block of the saphenous nerve. The secondary objectives are to compare the pain relief and quality of life of participants in these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal saphenous nerve block | Active comparator | Procedure: Saphenous Nerve BlockThe anesthesiologist will administer a saphenous proximal nerve block if specified in the randomization envelope. |
| Distal saphenous nerve block | Active comparator | Procedure: Saphenous Nerve BlockThe anesthesiologist will administer a saphenous distal nerve block if specified in the randomization envelope. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Upcoming elective foot or ankle surgery
Key exclusion criteria (4 listed)
- Preoperative weakness in knee extension
- Documented neuropathy
- Previous knee surgery
- Inability to provide informed consent
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 BlockA nerve block will be performed by the anesthesiologist. The location of the nerve block will be per randomization envelope (proximal vs. distal) and performed just prior to foot or ankle surgical procedures that require a saphenous nerve block | Procedure or surgery | Distal saphenous nerve block, Proximal saphenous nerve block |
Primary outcome
knee extensor strength measured in kilograms
Time frame: change from baseline preoperatively to 30 minutes after nerve block placement
Strength of the knee extensors in both treatment arms (distal vs. proximal block) will be tested preoperatively and again 30 minutes after the nerve block by using a hand-held dynamometer measured in kilograms
2 secondary outcomes
pain level
Time frame: change from baseline preoperatively to two weeks post-operatively
quality of life assessment
Time frame: change from baseline preoperatively to two weeks post-operatively
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 25 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Paul J Juliano, M.D. principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saphenous Nerve Block in people with Foot Injury and Ankle Injury, run by Paul J. Juliano, M.D. 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 2 inclusion and 4 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 25 Jun 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?
knee extensor strength measured in kilograms (time frame: change from baseline preoperatively to 30 minutes after nerve block placement). 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 25 Jun 2019.