Foot SurgeryPhase 4NCT01325012
Ultrasound-Guided Continuous Sciatic Nerve Blocks: Popliteal Versus Subgluteal Catheters
A Phase 4 study testing Subgluteal Sciatic Nerve Block and Popliteal Sciatic Nerve Block in people with Foot Surgery, run by University of California, San Diego at 2 sites in United States.
Trial summary
To determine the relationship between perineural catheter location along the sciatic nerve (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided continuous sciatic nerve blocks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Surgery
- What is being tested?
- Subgluteal Sciatic Nerve Block and Popliteal Sciatic Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Mar 2013
- Phase
- Phase 4
- 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
Who may be able to join
- undergoing foot surgery with a sciatic perineural catheter for postoperative analgesia
- spending the first postoperative night hospitalized
- age 18 years or older
Who cannot join
- pregnancy
- inability to communicate with the investigators and hospital staff
- incarceration
- clinical neuropathy in the surgical extremity
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSD Medical Center, Thornton
La Jolla, California
UCSD Medical Center Hillcrest
San Diego, California, 92103
About this study
To determine the relationship between perineural catheter location along the sciatic nerve (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided continuous sciatic nerve blocks.
- Conditions
- Foot Surgery
- Being tested
- Subgluteal Sciatic Nerve Block, Popliteal Sciatic Nerve Block
- Keywords
- Pain, Surgery, Catheter, Nerve Block, Popliteal, Subgluteal, Sciatic, UCSD, Moderate-to-severe pain, Perineural Catheter, Orthopedic Surgery, foot surgery surgery, sciatic perineural catheter, age =>18
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgluteal Sciatic Nerve BlockProcedure or surgery
Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle. After catheter placement, outcome measures will be assessed.
Popliteal Sciatic Nerve BlockProcedure or surgery
Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After Catheter placement outcome measures will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Subgluteal Sciatic Nerve Block | Active comparator | Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle. Receives: Procedure: Subgluteal Sciatic Nerve Block |
| Popliteal Sciatic Nerve Block | Active comparator | Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. Receives: Procedure: Popliteal Sciatic Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength (MVIC) of the hamstring muscles
We will evaluate hamstring strength which is innervated by the sciatic nerve with an isometric force electromechanical dynamometer to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90º
Measured: 08:00-09:00 morning after surgery as a percentage of baseline
Secondary outcomes (6)
Sensory Effect
We will evaluate tolerance of transcutaneous electrical stimulation. Electrocardiogram pads will be placed on the plantar and dorsal aspects of the foot, and attached to a nerve stimulator. The current will be increased from 0 mA until subjects described a "buzzing" sensation (not painful), at which time the current will be recorded as the tolerated level and the nerve stimulator turned off.
Measured: 08:00-09:00 morning after surgery
Pain Scores
Surgical pain scores both average and worse as collected by nursing staff; and also the average and worse pain during the primary endpoint measurement
Measured: from leaving the PACU until 08:00 the morning after surgery
Sleep Disturbances
Total number of times patient woke in the night due to surgical pain.
Measured: recorded at 08:00-09:00 the morning after surgery for the previous night
Total Infusion
Total infusiond duration in time and volume and total number of boluses delivered via catheter.
Measured: recorded at 08:00-09:00 the morning following Surgery
Anesthetic Leakage
Leakage from the catheter site noted by patient.
Measured: recorded at 08:00-09:00 the morning following Surgery
analgesic consumption
Hourly analgesic consumption.
Measured: end of PACU stay until 08:00-09:00 the morning following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Surgeon doing procedures amenable to this study left institution.
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 University of California, San DiegoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, M.D., M.S., Principal investigator, University of California, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325012
- Sponsor's protocol ID
- Subgluteal vs Popliteal
- Status last verified
- Mar 2013
- First submitted
- 28 Mar 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Continuous Sciatic Nerve Blocks: Popliteal Versus Subgluteal Catheters
- ClinicalTrials.gov ID
- NCT01325012
- Acronym / sponsor ID
- Subgluteal vs Popliteal
- Conditions
- Foot Surgery
- Keywords
- Pain, Surgery, Catheter, Nerve Block, Popliteal, Subgluteal, Sciatic, UCSD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Surgeon doing procedures amenable to this study left institution.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Mar 2011 (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.
To determine the relationship between perineural catheter location along the sciatic nerve (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided continuous sciatic nerve blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgluteal Sciatic Nerve Block | Active comparator | Procedure: Subgluteal Sciatic Nerve BlockPatients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle. |
| Popliteal Sciatic Nerve Block | Active comparator | Procedure: Popliteal Sciatic Nerve BlockPatients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing foot surgery with a sciatic perineural catheter for postoperative analgesia
- spending the first postoperative night hospitalized
- age 18 years or older
Key exclusion criteria (4 listed)
- pregnancy
- inability to communicate with the investigators and hospital staff
- incarceration
- clinical neuropathy in the surgical extremity
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 |
|---|---|---|
| Subgluteal Sciatic Nerve BlockPatients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle. After catheter placement, outcome measures will be assessed. | Procedure or surgery | Subgluteal Sciatic Nerve Block |
| Popliteal Sciatic Nerve BlockPatients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After Catheter placement outcome measures will be assessed. | Procedure or surgery | Popliteal Sciatic Nerve Block |
Primary outcome
Muscle Strength (MVIC) of the hamstring muscles
Time frame: 08:00-09:00 morning after surgery as a percentage of baseline
We will evaluate hamstring strength which is innervated by the sciatic nerve with an isometric force electromechanical dynamometer to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90º
6 secondary outcomes
Sensory Effect
Time frame: 08:00-09:00 morning after surgery
Pain Scores
Time frame: from leaving the PACU until 08:00 the morning after surgery
Sleep Disturbances
Time frame: recorded at 08:00-09:00 the morning after surgery for the previous night
Total Infusion
Time frame: recorded at 08:00-09:00 the morning following Surgery
Anesthetic Leakage
Time frame: recorded at 08:00-09:00 the morning following Surgery
analgesic consumption
Time frame: end of PACU stay until 08:00-09:00 the morning following surgery
Results and safety
The study was stopped early (reason given: Surgeon doing procedures amenable to this study left institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
Related trials for Foot Surgery
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
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 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.
Brian M Ilfeld, M.D., M.S. principal investigator
University of California, Department of Anesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Subgluteal Sciatic Nerve Block and Popliteal Sciatic Nerve Block in people with Foot Surgery, run by University of California, San Diego at 2 sites 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 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: stopped early, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Surgeon doing procedures amenable to this study left institution.). Results are not available in the source record.
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?
Muscle Strength (MVIC) of the hamstring muscles (time frame: 08:00-09:00 morning after surgery as a percentage of baseline). 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 29 Mar 2013.