Postoperative PainPhase 4NCT00876681
Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks
A Phase 4 study testing Popliteal catheter placed via ultrasound or electrical stimulation in people with Postoperative Pain and Foot Numbness, run by University of California, San Diego at 1 site in United States.
Trial summary
Research study to determine if pain relief following foot and/or ankle surgery is influenced by the technique used to place perineural catheter. The catheters are placed using ultrasound-guidance or nerve stimulation and the method is selected at random using a computer program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Foot Numbness
- What is being tested?
- Popliteal catheter placed via ultrasound or electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2009
- 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 planned popliteal-sciatic perineural catheter for postoperative analgesia
- Expected postoperative pain to be at least moderate in severity the day following surgery (often not adequately treatable with oral analgesics alone)
- Age 18 years or older
Who cannot join
- Pregnancy
- Inability to communicate wiht the investigators and hospital staff
- Incarceration
- Current chronic opioid use (daily opioid equivalent of >10mg oxycodone for more than the previous four weeks)
- History of alcohol or opioid abuse
- Neuropathy in the surgical extremity
- Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks: A Randomized, Controlled Trial
Research study to determine if pain relief following foot and/or ankle surgery is influenced by the technique used to place perineural catheter. The catheters are placed using ultrasound-guidance or nerve stimulation and the method is selected at random using a computer program. This may help to determine if one of these methods is associated with an increased success rate and incidence of foot numbness during the infusion.
Read the detailed description
Specific Aim 1: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and quality of postoperative analgesia during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.
Hypothesis 1: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with decreased pain the morning following moderate-to-severely painful orthopedic surgery as measured with a numeric rating scale.
Specific Aim 2: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and degree of sensory deficit during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.
Hypothesis 2: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with increased sensory deficit the day following moderate-to-severely painful orthopedic surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at the time of the data-collection phone call.
- Conditions
- Postoperative Pain, Foot Numbness
- Being tested
- Popliteal catheter placed via ultrasound or electrical stimulation
- Keywords
- Catheter, Ultrasound-guidance, Nerve Stimulation, Electrical stimulation, nerve block, UCSD, Orthopedic surgery, Foot/ankle pain, Foot/ankle numbness, Popliteal-Sciatic Catheters
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popliteal catheter placed via ultrasound or electrical stimulationProcedure or surgery
Patients will be randomized to one of two groups: Popliteal-sciatic catheter placed via ultrasound-guidance or placed via electrical stimulation. All patients will be given 40ml of 1.5% mepivicaine prior to surgery and then given a pain pump after surgery containing 0.2% ropivacaine. The patients pain scores will be assessed just prior to surgery and the day following surgery. The time of catheter placement and numbness the patient is experiencing in their foot and toes is also assessed and recorded by research staff.
| Study group | Role | What they receive |
|---|---|---|
| 1. Ultrasound | Active comparator | Ultrasound method of placement is selected randomly, using a computer program. The patient is asked their pain and discomfort using a 0-10 scale where 0=no pain/discomfort and 10=worst pain/discomfort imaginable. The patient is asked this question prior to surgery, but after catheter placement and then again the first day after surgery. Time of placement is also measured and begins when the ultrasound probe first touches the skin. Patients are also asked the numbness of their foot and toes based on a 0-10 scale where 0=no numbness and 10=completely numb. Receives: Procedure: Popliteal catheter placed via ultrasound or electrical stimulation |
| 2. Electrical Stimulation | Active comparator | Electrical stimulation (nerve stimulation) method of placement is selected randomly, using a computer program. The patient is asked their pain and discomfort using a 0-10 scale where 0=no pain/discomfort and 10=worst pain/discomfort imaginable. The patient is asked this question prior to surgery, but after catheter placement, and then again the first day after surgery. Time of placement is also measured and begins when the nerve stimulation needle first touches the skin. Patients are also asked the numbness of their foot and toes based on a 0-10 scale where 0=no numbness and 10=completely numb. Receives: Procedure: Popliteal catheter placed via ultrasound or electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measurement will be the average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (NRS, 0-10, 0=no pain, 10=worst imaginable pain).
Measured: 3 hours on day following surgery
Secondary outcomes (4)
Sensory deficit in the operative limb the day following surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at time of the data collection phone call.
Measured: 1 day
Time for catheter placement. Time will begin when probe is placed on skin for the ultrasound-guidance method and when the nerve stimulation needle is placed on the skin for the electrical stimulation method.
Measured: 30 minutes
Catheter placement success rate as assessed by attending physician who will test for sensory deficit.
Measured: 30 minutes
Worst pain experienced since the surgery in the surgical limb as measured on the 0-10 NRS as assessed by the research staff when they call the patient the day following surgery.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Brian M Ilfeld, M.D., M.S., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876681
- Sponsor's protocol ID
- Popliteal Catheter: US vs. NS
- Status last verified
- Oct 2009
- First submitted
- 3 Apr 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mariano ER, Loland VJ, Sandhu NS, Bishop ML, Lee DK, Schwartz AK, Girard PJ, Ferguson EJ, Ilfeld BM. Comparative efficacy of ultrasound-guided and stimulating popliteal-sciatic perineural catheters for postoperative analgesia. Can J Anaesth. 2010 Oct;57(10):919-26. doi: 10.1007/s12630-010-9364-7. Epub 2010 Aug 11.
PubMed 20700680
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00876681
- Acronym / sponsor ID
- Popliteal Catheter: US vs. NS
- Conditions
- Postoperative Pain, Foot Numbness
- Keywords
- Catheter, Ultrasound-guidance, Nerve Stimulation, Electrical stimulation, nerve block, UCSD, Orthopedic surgery, Foot/ankle pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Apr 2009 (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 if pain relief following foot and/or ankle surgery is influenced by the technique used to place perineural catheter. The catheters are placed using ultrasound-guidance or nerve stimulation and the method is selected at random using a computer program. This may help to determine if one of these methods is associated with an increased success rate and incidence of foot numbness during the infusion.
Detailed description
Specific Aim 1: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and quality of postoperative analgesia during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.
Hypothesis 1: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with decreased pain the morning following moderate-to-severely painful orthopedic surgery as measured with a numeric rating scale.
Specific Aim 2: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and degree of sensory deficit during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.
Hypothesis 2: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with increased sensory deficit the day following moderate-to-severely painful orthopedic surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at the time of the data-collection phone call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Ultrasound | Active comparator | Procedure: Popliteal catheter placed via ultrasound or electrical stimulationUltrasound method of placement is selected randomly, using a computer program. The patient is asked their pain and discomfort using a 0-10 scale where 0=no pain/discomfort and 10=worst pain/discomfort imaginable. The patient is asked this question prior to surgery, but after catheter placement and then again the first day after surgery. Time of placement is also measured and begins when the ultrasound probe first touches the skin. Patients are also asked the numbness of their foot and toes based on a 0-10 scale where 0=no numbness and 10=completely numb. |
| 2. Electrical Stimulation | Active comparator | Procedure: Popliteal catheter placed via ultrasound or electrical stimulationElectrical stimulation (nerve stimulation) method of placement is selected randomly, using a computer program. The patient is asked their pain and discomfort using a 0-10 scale where 0=no pain/discomfort and 10=worst pain/discomfort imaginable. The patient is asked this question prior to surgery, but after catheter placement, and then again the first day after surgery. Time of placement is also measured and begins when the nerve stimulation needle first touches the skin. Patients are also asked the numbness of their foot and toes based on a 0-10 scale where 0=no numbness and 10=completely numb. |
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 surgery with a planned popliteal-sciatic perineural catheter for postoperative analgesia
- Expected postoperative pain to be at least moderate in severity the day following surgery (often not adequately treatable with oral analgesics alone)
- Age 18 years or older
Key exclusion criteria (7 listed)
- Pregnancy
- Inability to communicate wiht the investigators and hospital staff
- Incarceration
- Current chronic opioid use (daily opioid equivalent of >10mg oxycodone for more than the previous four weeks)
- History of alcohol or opioid abuse
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 |
|---|---|---|
| Popliteal catheter placed via ultrasound or electrical stimulationPatients will be randomized to one of two groups: Popliteal-sciatic catheter placed via ultrasound-guidance or placed via electrical stimulation. All patients will be given 40ml of 1.5% mepivicaine prior to surgery and then given a pain pump after surgery containing 0.2% ropivacaine. The patients pain scores will be assessed just prior to surgery and the day following surgery. The time of catheter placement and numbness the patient is experiencing in their foot and toes is also assessed and recorded by research staff. | Procedure or surgery | 1. Ultrasound, 2. Electrical Stimulation |
Primary outcome
The primary outcome measurement will be the average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (NRS, 0-10, 0=no pain, 10=worst imaginable pain).
Time frame: 3 hours on day following surgery
4 secondary outcomes
Sensory deficit in the operative limb the day following surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at time of the data collection phone call.
Time frame: 1 day
Time for catheter placement. Time will begin when probe is placed on skin for the ultrasound-guidance method and when the nerve stimulation needle is placed on the skin for the electrical stimulation method.
Time frame: 30 minutes
Catheter placement success rate as assessed by attending physician who will test for sensory deficit.
Time frame: 30 minutes
Worst pain experienced since the surgery in the surgical limb as measured on the 0-10 NRS as assessed by the research staff when they call the patient the day following surgery.
Time frame: 1 day
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 8 Oct 2009.
- Derived from this study: PubMed 20700680Mariano ER, Loland VJ, Sandhu NS, Bishop ML, Lee DK, Schwartz AK, Girard PJ, Ferguson EJ, Ilfeld BM. Comparative efficacy of ultrasound-guided and stimulating popliteal-sciatic perineural catheters for postoperative analgesia. Can J Anaesth. 2010 Oct;57(10):919-26. doi: 10.1007/s12630-010-9364-7. Epub 2010 Aug 11.
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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 Popliteal catheter placed via ultrasound or electrical stimulation in people with Postoperative Pain and Foot Numbness, 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 3 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 8 Oct 2009. 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?
The primary outcome measurement will be the average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (NRS, 0-10, 0=no pain, 10=worst imaginable pain). (time frame: 3 hours on day following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876681, which also lists 1 linked publication.
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 8 Oct 2009.