Foot SurgeryNCT01049906
Popliteal Sciatic Nerve Block Catheter Placement for Foot Surgery
A study testing Placement of nerve block catheter in people with Foot Surgery and Ankle Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and motor blockade obtained with stimulating popliteal catheters versus those placed without nerve stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Surgery, Ankle Surgery
- What is being tested?
- Placement of nerve block catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo foot or ankle surgery at Mayo Clinic Jacksonville
Who cannot join
- emergency surgery
- peripheral neuropathy in the distribution of the sciatic nerve on the operative side
- history of recent alcohol or drug abuse
- allergy to local anesthetics
- pregnancy
- coagulopathy
- subjects declined to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine the Quality of Sensory and Motor Blockade of Popliteal Sciatic Nerve Block Catheters Placed Under Ultrasound Guidance With and Without Nerve Stimulation
Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and motor blockade obtained with stimulating popliteal catheters versus those placed without nerve stimulation.
- Conditions
- Foot Surgery, Ankle Surgery
- Being tested
- Placement of nerve block catheter
- Keywords
- foot surgery, ankle surgery, Patients scheduled for foot and ankle surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of nerve block catheterProcedure or surgery
Placement of nerve block catheter with nerve stimulator and ultrasound
Placement of nerve block catheterProcedure or surgery
Placement of nerve block catheter with ultrasound only
| Study group | Role | What they receive |
|---|---|---|
| Nerve stimulation and Ultrasound | Active comparator | Not described Receives: Procedure: Placement of nerve block catheter |
| Ultrasound without nerve stimulation | Active comparator | Not described Receives: Procedure: Placement of nerve block catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete motor and sensory anesthesia in the sciatic nerve distribution.
Measured: Upon block placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Christopher Robards, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049906
- Sponsor's protocol ID
- 07-008192
- Status last verified
- Jun 2012
- First submitted
- 13 Jan 2010
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Quality of Sensory and Motor Blockade of Popliteal Sciatic Nerve Block Catheters Placed Under Ultrasound Guidance With and Without Nerve Stimulation
- ClinicalTrials.gov ID
- NCT01049906
- Acronym / sponsor ID
- 07-008192
- Conditions
- Foot Surgery, Ankle Surgery
- Keywords
- foot surgery, ankle surgery, Patients scheduled for foot and ankle surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Jan 2010 (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.
Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and motor blockade obtained with stimulating popliteal catheters versus those placed without nerve stimulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve stimulation and Ultrasound | Active comparator | Procedure: Placement of nerve block catheter |
| Ultrasound without nerve stimulation | Active comparator | Procedure: Placement of nerve block catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to undergo foot or ankle surgery at Mayo Clinic Jacksonville
Key exclusion criteria (7 listed)
- emergency surgery
- peripheral neuropathy in the distribution of the sciatic nerve on the operative side
- history of recent alcohol or drug abuse
- allergy to local anesthetics
- pregnancy
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 |
|---|---|---|
| Placement of nerve block catheterPlacement of nerve block catheter with nerve stimulator and ultrasound | Procedure or surgery | Nerve stimulation and Ultrasound |
| Placement of nerve block catheterPlacement of nerve block catheter with ultrasound only | Procedure or surgery | Ultrasound without nerve stimulation |
Primary outcome
Complete motor and sensory anesthesia in the sciatic nerve distribution.
Time frame: Upon block placement
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 21 Jun 2012.
Related trials for Foot Surgery
Not yet recruitingObservational study
Muscle MRI Fat Fraction Before Surgery to Predict Strength Recovery After Foot-Drop Surgery in Charcot-Marie-Tooth Disease
Foot Drop, Charcot-Marie-Tooth Disease Type 1A
RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
Recruiting
Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery
Gastrocnemius, Ankle Surgery
Not yet recruitingObservational study
Markerless Motion Capture in Foot and Ankle Surgery
Motion Capture of the Foot and Ankle Joint
Not yet recruitingPhase 4
Suzetrigine for Postoperative Pain After Total Ankle Replacement
Ankle Osteoarthritis, Postoperative Pain
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.
Christopher Robards, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of nerve block catheter in people with Foot Surgery and Ankle Surgery, run by Mayo Clinic 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 1 inclusion and 7 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 21 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?
Complete motor and sensory anesthesia in the sciatic nerve distribution. (time frame: Upon 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 21 Jun 2012.