Popliteal Nerve BlockPhase 4NCT01229696
Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia
A Phase 4 study testing Catheter Placed At Bifurcation and Catheter Placed 5cm Above Bifurcation in people with Popliteal Nerve Block and Foot Surgery, run by University of California, San Diego at 1 site in United States.
Trial summary
Research study to determine the relationship between perineural catheter tip location relative to the sciatic nerve bifurcation and postoperative analgesia for continuous popliteal nerve blocks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Popliteal Nerve Block, Foot Surgery, Ankle Surgery
- What is being tested?
- Catheter Placed At Bifurcation and Catheter Placed 5cm Above Bifurcation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2015
- 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 surgery with a popliteal perineural catheter for postoperative analgesia
- 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
- chronic high-dose opioid use
- a history of opioid abuse
- surgery outside of ipsilateral sciatic and saphenous nerve distributions
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Medical Centers (Hillcrest and Thornton)
San Diego, California, 92103
About this study
Research study to determine the relationship between perineural catheter tip location relative to the sciatic nerve bifurcation and postoperative analgesia for continuous popliteal nerve blocks.
Read the detailed description
Hypothesis: During a continuous popliteal nerve block, postoperative analgesia will be improved with the perineural catheter tip at the level of the sciatic nerve bifurcation compared to when the catheter tip is 5 cm cephalad/proximal to the bifurcation.
- Being tested
- Catheter Placed At Bifurcation, Catheter Placed 5cm Above Bifurcation
- Keywords
- Popliteal, UCSD, Postoperative pain, Foot surgery, Ankle surgery, Popliteal Catheter, Popliteal Nerve Block, Lower extremity surgery, Bifurcation, Catheter Insertion Site
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Placed At BifurcationProcedure or surgery
Patients randomized to this group will receive a sciatic nerve block placed at the bifurcaton of the sciatic nerve and outcome measures will be tested.
Catheter Placed 5cm Above BifurcationProcedure or surgery
Patients randomized to this group will receive a sciatic nerve block placed 5cm above the bifurcaton of the sciatic nerve and outcome measures will be tested.
| Study group | Role | What they receive |
|---|---|---|
| At Bifurcation | Active comparator | Patients randomized to this group will receive a sciatic nerve block placed at the bifurcaton of the sciatic nerve and outcome measures will be tested. Receives: Procedure: Catheter Placed At Bifurcation |
| 5cm Above Bifurcation | Active comparator | Patients randomized to this group will receive a sciatic nerve block placed 5cm above the bifurcaton of the sciatic nerve and outcome measures will be tested. Receives: Procedure: Catheter Placed 5cm Above Bifurcation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain
The average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).
Measured: 1 Day following surgery
Secondary outcomes (4)
Analgesic Use
Total oral opioid use since surgery and total IV analgesics if any.
Measured: 1 day following surgery
Sleep Disturbances
Total number of times patient woke due to pain the night following surgery.
Measured: 1 day following surgery
Infusion Side Effects
Numbness of foot and toes on a 0-10 scale where 0=no numbness and 10=complete numbness.
Measured: 1 day following surgery
Satisfaction of pain control
Patients will give an answer on a 0-10 scale where 0=completely unsatisfied wiht pain control and 10=completely satisfied with pain control.
Measured: 1 day following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal Nerve BlockStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
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, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229696
- Sponsor's protocol ID
- Popliteal Bifurcation
- Status last verified
- Apr 2016
- First submitted
- 27 Oct 2010
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT01229696
- Acronym / sponsor ID
- Popliteal Bifurcation
- Keywords
- Popliteal, UCSD, Postoperative pain, Foot surgery, Ankle surgery, Popliteal Catheter, Popliteal Nerve Block, Lower extremity surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Oct 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.
Research study to determine the relationship between perineural catheter tip location relative to the sciatic nerve bifurcation and postoperative analgesia for continuous popliteal nerve blocks.
Detailed description
Hypothesis: During a continuous popliteal nerve block, postoperative analgesia will be improved with the perineural catheter tip at the level of the sciatic nerve bifurcation compared to when the catheter tip is 5 cm cephalad/proximal to the bifurcation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At Bifurcation | Active comparator | Procedure: Catheter Placed At BifurcationPatients randomized to this group will receive a sciatic nerve block placed at the bifurcaton of the sciatic nerve and outcome measures will be tested. |
| 5cm Above Bifurcation | Active comparator | Procedure: Catheter Placed 5cm Above BifurcationPatients randomized to this group will receive a sciatic nerve block placed 5cm above the bifurcaton of the sciatic nerve and outcome measures will be tested. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing surgery with a popliteal perineural catheter for postoperative analgesia
- age 18 years or older
Key exclusion criteria (7 listed)
- pregnancy
- inability to communicate with the investigators and hospital staff
- incarceration
- clinical neuropathy in the surgical extremity
- chronic high-dose opioid use
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 |
|---|---|---|
| Catheter Placed At BifurcationPatients randomized to this group will receive a sciatic nerve block placed at the bifurcaton of the sciatic nerve and outcome measures will be tested. | Procedure or surgery | At Bifurcation |
| Catheter Placed 5cm Above BifurcationPatients randomized to this group will receive a sciatic nerve block placed 5cm above the bifurcaton of the sciatic nerve and outcome measures will be tested. | Procedure or surgery | 5cm Above Bifurcation |
Primary outcome
Average Pain
Time frame: 1 Day following surgery
The average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).
4 secondary outcomes
Analgesic Use
Time frame: 1 day following surgery
Sleep Disturbances
Time frame: 1 day following surgery
Infusion Side Effects
Time frame: 1 day following surgery
Satisfaction of pain control
Time frame: 1 day following surgery
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 11 Apr 2016.
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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.
Brian M Ilfeld, M.D., M.S. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Catheter Placed At Bifurcation and Catheter Placed 5cm Above Bifurcation in people with Popliteal Nerve Block and Foot Surgery, run by University of California, San Diego 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 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 11 Apr 2016. 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.
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 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?
Average Pain (time frame: 1 Day following surgery). 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 11 Apr 2016.