Ankle/Foot SurgeryNCT00803426
Ultrasound Guided Popliteal Fossa Block. Does Blockade Distal to Sciatic Nerve Bifurcation Speed Onset Time? A Prospective, Randomized Trial
A study testing Sciatic nerve blockade for ankle/foot surgery in people with Ankle/Foot Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Sciatic nerve block is used routinely in ankle and foot surgery. It is applied often by a posterior approach at the popliteal fossa, near where the nerve divides into the common peroneal and tibial nerves. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ankle/Foot Surgery
- What is being tested?
- Sciatic nerve blockade for ankle/foot surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Apr 2009
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III
- 18-85 years of age, inclusive
- 50-120 kg, inclusive
- 150 cm of height or grater Scheduled for major elective foot or ankle surgery for which sciatic nerve block is indicated
Who cannot join
- Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
- Significant peripheral neuropathy or neurological disorder affecting the lower extremity
- Pregnancy
- History of alcohol or drug dependency/abuse
- History of significant psychiatric conditions that may affect patient assessment
Trial locations and contacts
1 site in 1 country.
About this study
Sciatic nerve block is used routinely in ankle and foot surgery. It is applied often by a posterior approach at the popliteal fossa, near where the nerve divides into the common peroneal and tibial nerves. Due to the size of the sciatic nerve, the largest in the body, infiltration of anesthetic and onset of anesthesia can take a significant amount of time. This study hypothesizes that selectively blocking both the common peroneal and the tibial nerves distal to the bifurcation may result in a faster block onset than blockade of the sciatic nerve proximal to its bifurcation.
Read the detailed description
Sciatic nerve block (SNB) has been shown to reduce postoperative pain and opioid requirements, as well as improve patient satisfaction after outpatient foot and ankle surgery. The sciatic nerve divides into two terminal branches (the common peroneal and tibial nerves) in the popliteal fossa. Through these two branches it innervates the entire leg, ankle and foot except for the skin over the anterior-medial aspect of the leg, which is supplied by the saphenous nerve, a branch of the femoral nerve.
Many approaches have been described to sciatic nerve blockade. High in the thigh or buttock are the classical posterior approach, the supine approach, and the anterior approach. In the popliteal fossa, a posterior, a lateral and a medial approach have been described. The popliteal fossa approaches are most commonly used to provide regional anesthesia and/or analgesia for major foot and ankle surgery.
Traditional nerve localization techniques include seeking paresthesiae on needle to nerve contact, or alternatively seeking a muscle response to electrical nerve stimulation using a blunt insulated needle and a peripheral nerve stimulator. However, block results with traditional nerve localization techniques are highly variable, often requiring high local anesthetic doses, and a prolonged onset time. When a distal approach in the popliteal fossa is used (5-7 cm above the knee crease) with a nerve stimulator technique, a double motor response (both tibial and peroneal components) may be required to achieve consistent success.
Recently, ultrasound guided techniques for SNB at the popliteal fossa have been described. Ultrasound guidance offers the unique advantages of real time anatomic assessment of the sciatic nerve itself, its site of bifurcation, and its relationship to surrounding muscles and the popliteal vessels. In a recent study we have shown that ultrasound guidance significantly improves the success rate of SNB at the popliteal fossa via a posterior approach.
Despite these advantages, a prolonged onset time for complete blockade of up to 30-60 minutes (depending on the choice and dose of local anesthetic) is common. This may be a limitation to the widespread use of popliteal sciatic nerve blockade in a peri-operative environment, where a faster block onset may be preferable. This delayed onset has been attributed to the large size of the sciatic nerve. Therefore logically it should be faster to induce a block by depositing the local anesthetic after the sciatic nerve divides where the connective tissues decrease and the nerves are superficial. No exact mathematical data is available looking into onset times for nerves with varying diameter, as no previous studies are done in this area.
- Conditions
- Ankle/Foot Surgery
- Being tested
- Sciatic nerve blockade for ankle/foot surgery
- Keywords
- ultrasound-guided regional anesthesia, nerve block, popliteal fossa, sciatic nerve, common peroneal nerve, tibial nerve, onset time, ankle surgery, foot surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic nerve blockade for ankle/foot surgeryProcedure or surgery
Injection of local anesthetic near the nerve to achieve anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Local anesthetic will be injected above the division of the sciatic nerve. Receives: Procedure: Sciatic nerve blockade for ankle/foot surgery |
| 2 | Experimental | Local anesthetic will be injected below the division of the sciatic nerve, around the common peroneal and tibial nerves. Receives: Procedure: Sciatic nerve blockade for ankle/foot surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of anesthesia.
Measured: every 5 minutes until start of surgery
Secondary outcomes (1)
Block procedure time, complications, location of the sciatic nerve bifurcation, postoperative pain, patient satisfaction with pain control
Measured: up to 2 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJul 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.
- Other trials for Ankle/Foot SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahi Perlas, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803426
- Sponsor's protocol ID
- 07-0495-B
- Status last verified
- Jul 2009
- First submitted
- 4 Dec 2008
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Popliteal Fossa Block. Does Blockade Distal to Sciatic Nerve Bifurcation Speed Onset Time? A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT00803426
- Acronym / sponsor ID
- 07-0495-B
- Conditions
- Ankle/Foot Surgery
- Keywords
- ultrasound-guided regional anesthesia, nerve block, popliteal fossa, sciatic nerve, common peroneal nerve, tibial nerve, onset time, ankle surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Dec 2008 (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.
Sciatic nerve block is used routinely in ankle and foot surgery. It is applied often by a posterior approach at the popliteal fossa, near where the nerve divides into the common peroneal and tibial nerves. Due to the size of the sciatic nerve, the largest in the body, infiltration of anesthetic and onset of anesthesia can take a significant amount of time. This study hypothesizes that selectively blocking both the common peroneal and the tibial nerves distal to the bifurcation may result in a faster block onset than blockade of the sciatic nerve proximal to its bifurcation.
Detailed description
Sciatic nerve block (SNB) has been shown to reduce postoperative pain and opioid requirements, as well as improve patient satisfaction after outpatient foot and ankle surgery. The sciatic nerve divides into two terminal branches (the common peroneal and tibial nerves) in the popliteal fossa. Through these two branches it innervates the entire leg, ankle and foot except for the skin over the anterior-medial aspect of the leg, which is supplied by the saphenous nerve, a branch of the femoral nerve.
Many approaches have been described to sciatic nerve blockade. High in the thigh or buttock are the classical posterior approach, the supine approach, and the anterior approach. In the popliteal fossa, a posterior, a lateral and a medial approach have been described. The popliteal fossa approaches are most commonly used to provide regional anesthesia and/or analgesia for major foot and ankle surgery.
Traditional nerve localization techniques include seeking paresthesiae on needle to nerve contact, or alternatively seeking a muscle response to electrical nerve stimulation using a blunt insulated needle and a peripheral nerve stimulator. However, block results with traditional nerve localization techniques are highly variable, often requiring high local anesthetic doses, and a prolonged onset time. When a distal approach in the popliteal fossa is used (5-7 cm above the knee crease) with a nerve stimulator technique, a double motor response (both tibial and peroneal components) may be required to achieve consistent success.
Recently, ultrasound guided techniques for SNB at the popliteal fossa have been described. Ultrasound guidance offers the unique advantages of real time anatomic assessment of the sciatic nerve itself, its site of bifurcation, and its relationship to surrounding muscles and the popliteal vessels. In a recent study we have shown that ultrasound guidance significantly improves the success rate of SNB at the popliteal fossa via a posterior approach.
Despite these advantages, a prolonged onset time for complete blockade of up to 30-60 minutes (depending on the choice and dose of local anesthetic) is common. This may be a limitation to the widespread use of popliteal sciatic nerve blockade in a peri-operative environment, where a faster block onset may be preferable. This delayed onset has been attributed to the large size of the sciatic nerve. Therefore logically it should be faster to induce a block by depositing the local anesthetic after the sciatic nerve divides where the connective tissues decrease and the nerves are superficial. No exact mathematical data is available looking into onset times for nerves with varying diameter, as no previous studies are done in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Sciatic nerve blockade for ankle/foot surgeryLocal anesthetic will be injected above the division of the sciatic nerve. |
| 2 | Experimental | Procedure: Sciatic nerve blockade for ankle/foot surgeryLocal anesthetic will be injected below the division of the sciatic nerve, around the common peroneal and tibial nerves. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status I-III
- 18-85 years of age, inclusive
- 50-120 kg, inclusive
- 150 cm of height or grater Scheduled for major elective foot or ankle surgery for which sciatic nerve block is indicated
Key exclusion criteria (5 listed)
- Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
- Significant peripheral neuropathy or neurological disorder affecting the lower extremity
- Pregnancy
- History of alcohol or drug dependency/abuse
- History of significant psychiatric conditions that may affect patient assessment
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 |
|---|---|---|
| Sciatic nerve blockade for ankle/foot surgeryInjection of local anesthetic near the nerve to achieve anesthesia. | Procedure or surgery | 1, 2 |
Primary outcome
Onset time of anesthesia.
Time frame: every 5 minutes until start of surgery
1 secondary outcome
Block procedure time, complications, location of the sciatic nerve bifurcation, postoperative pain, patient satisfaction with pain control
Time frame: up to 2 days post-operative
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 27 Nov 2017.
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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.
Anahi Perlas, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sciatic nerve blockade for ankle/foot surgery in people with Ankle/Foot Surgery, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 5 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 27 Nov 2017. 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 Canada. 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?
Onset time of anesthesia. (time frame: every 5 minutes until start of 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 27 Nov 2017.