PainNCT00497276
Comparison of Ultrasound and Nerve Stimulation Technique for Continuous Sciatic Nerve Block
A study testing placement of popliteal catheter in people with Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
The most useful method to manage pain after major foot and ankle surgery is infusion of local anesthetic with a catheter close to the sciatic nerve in the popliteal space above the knee joint. Inaccurate catheter placement and spread of local anesthetic account for most failures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- placement of popliteal catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective posterior foot and/or ankle surgery
- calcaneus osteotomy
- subtalar arthrodesis
- total ankle arthroplasty
- ankle arthrodesis (non-arthroscopic) minimum age 18 years ASA I-III informed consent
Who cannot join
- coagulation disorders
- infection in the region of needle insertion
- systemic infection
- preoperative sciatic nerve neuropathy
- preoperative motor or sensory deficit in the operative extremity
- Charcot-Marie-Tooth disorder
Show all 13Show fewer
- diabetic neuropathy
- severe peripheral vascular disease
- allergy to local anesthetics
- lack of understanding of the visual analogue scale
- communication problems
- dementia
- body mass index above 35
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesiology, Aarhus University Hospital
Aarhus, DK-8000 Aarhus C
About this study
Official title: A Prospective, Randomized Comparison of Ultrasound Versus Nerve Stimulation Guidance of Popliteal, Sciatic Catheter Placement After Major Foot and Ankle Surgery: Clinical Outcome and Cost Analysis
The most useful method to manage pain after major foot and ankle surgery is infusion of local anesthetic with a catheter close to the sciatic nerve in the popliteal space above the knee joint.
Inaccurate catheter placement and spread of local anesthetic account for most failures.
Read more
The most prevalent method to place the catheter is the traditional nerve stimulation technique relying on surface anatomic landmarks and electrical stimulation to localize the sciatic nerve. In recent years ultrasound technique has been applied to provide real-time, visual guidance of catheter placement.
The purpose of this randomized, controlled trial is to compare the success rate, patient acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques.
Read the detailed description
Foot and ankle surgery is typically very painful for the first two days postoperatively due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, mouth dryness, respiratory depression, pruritus, vertigo and visual disturbances).
Single-shot technique provides analgesia for two to 30 hours even using analgesics with prolonged effect (bupivacaine, levobupivacaine, ropivacaine). The duration of the block depends on the local analgesic and the anatomical location. Popliteal block with bupivacaine last up to 24 hours. Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics and their adverse effects. Continuous, peripheral nerve block has gained popularity for foot and ankle surgery, because better analgesia is obtained compared to intravenous opioids, and similar analgesia with fewer adverse effects compared to epidural catheter technique.
Today the nerve stimulation technique is the most prevalent technique to introduce catheters for peripheral nerve blocks. The success rate for postoperative analgesia after foot and ankle surgery with popliteal catheters is variable - typically 70% in our department. The patients with catheter failure have severe postoperative pain, high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
Ultrasound technique was employed for peripheral nerve blocks for the first time in 1978. However the utility was technically limited. In recent years, the evolution of high-frequency transducers and mobile ultrasound units have facilitated the application of ultrasound-guided peripheral nerve blocks. This technique allows dynamic visualization of nerves, needle tip location and spread of local analgesic in real-time.
The empirical basis supporting the theoretical advantages of ultrasound-guided regional anesthesia consists mainly of observational studies. A few, randomized, controlled trials comparing ultrasound- and nerve stimulation technique favour the benefit of ultrasound concerning success rate, sensory onset time, duration of block, patient satisfaction and quality of block.
The purpose of this study is to establish whether ultrasound technique has higher success rate, better patient satisfaction and higher cost-effectiveness compared to electrical nerve stimulation using popliteal, sciatic catheters for postoperative analgesia after foot and ankle surgery.
- Conditions
- Pain
- Being tested
- placement of popliteal catheter
- Keywords
- Adults, Anesthesia recovery period, Comparative study, Electric stimulation, Humans, Nerve blocks/methods/indications, Patient satisfaction, Peripheral nerves, Sciatic nerve/ultrasonography, Ultrasonography, Treatment outcome, Nerve blocks/economics
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of popliteal catheterProcedure or surgery
Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Ultrasound guided placement of popliteal catheter Receives: Procedure: placement of popliteal catheter |
| II | Experimental | Nerve stimulation guided placement of popliteal catheter Receives: Procedure: placement of popliteal catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate: post-operative analgesia
Measured: First two post-operative days
Secondary outcomes (7)
Time consumption of catheter placement
Measured: Before surgery
Duration of post-operative observation
Measured: After surgery
Pain score
Measured: First two post-operative days
Nausea score
Measured: First two post-operative days
Sensory block
Measured: First two post-operative days
Patient acceptance
Measured: First two postoperative days
Cost-effectiveness
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Health, Denmark
- Investigators
- Thomas F Bendtsen, Ph.d., Principal investigator, Department of Anesthesiology, Aarhus University Hospital, Norrebrogade, DK-8000 Aarhus C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497276
- Sponsor's protocol ID
- 0-204-03-8/27
- Status last verified
- Dec 2009
- First submitted
- 4 Jul 2007
- Last updated
- 21 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ehlers L, Jensen JM, Bendtsen TF. Cost-effectiveness of ultrasound vs nerve stimulation guidance for continuous sciatic nerve block. Br J Anaesth. 2012 Nov;109(5):804-8. doi: 10.1093/bja/aes259. Epub 2012 Jul 31.
PubMed 22855632Bendtsen TF, Nielsen TD, Rohde CV, Kibak K, Linde F. Ultrasound guidance improves a continuous popliteal sciatic nerve block when compared with nerve stimulation. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):181-4. doi: 10.1097/aap.0b013e31820d421f.
PubMed 21425514
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of Ultrasound Versus Nerve Stimulation Guidance of Popliteal, Sciatic Catheter Placement After Major Foot and Ankle Surgery: Clinical Outcome and Cost Analysis
- ClinicalTrials.gov ID
- NCT00497276
- Acronym / sponsor ID
- 0-204-03-8/27
- Conditions
- Pain
- Keywords
- Adults, Anesthesia recovery period, Comparative study, Electric stimulation, Humans, Nerve blocks/methods/indications, Patient satisfaction, Peripheral nerves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- National Board of Health, Denmark
- Study start
- Aug 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Jul 2007 (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.
The most useful method to manage pain after major foot and ankle surgery is infusion of local anesthetic with a catheter close to the sciatic nerve in the popliteal space above the knee joint.
Inaccurate catheter placement and spread of local anesthetic account for most failures.
The most prevalent method to place the catheter is the traditional nerve stimulation technique relying on surface anatomic landmarks and electrical stimulation to localize the sciatic nerve. In recent years ultrasound technique has been applied to provide real-time, visual guidance of catheter placement.
The purpose of this randomized, controlled trial is to compare the success rate, patient acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques.
Detailed description
Foot and ankle surgery is typically very painful for the first two days postoperatively due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, mouth dryness, respiratory depression, pruritus, vertigo and visual disturbances).
Single-shot technique provides analgesia for two to 30 hours even using analgesics with prolonged effect (bupivacaine, levobupivacaine, ropivacaine). The duration of the block depends on the local analgesic and the anatomical location. Popliteal block with bupivacaine last up to 24 hours. Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics and their adverse effects. Continuous, peripheral nerve block has gained popularity for foot and ankle surgery, because better analgesia is obtained compared to intravenous opioids, and similar analgesia with fewer adverse effects compared to epidural catheter technique.
Today the nerve stimulation technique is the most prevalent technique to introduce catheters for peripheral nerve blocks. The success rate for postoperative analgesia after foot and ankle surgery with popliteal catheters is variable - typically 70% in our department. The patients with catheter failure have severe postoperative pain, high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
Ultrasound technique was employed for peripheral nerve blocks for the first time in 1978. However the utility was technically limited. In recent years, the evolution of high-frequency transducers and mobile ultrasound units have facilitated the application of ultrasound-guided peripheral nerve blocks. This technique allows dynamic visualization of nerves, needle tip location and spread of local analgesic in real-time.
The empirical basis supporting the theoretical advantages of ultrasound-guided regional anesthesia consists mainly of observational studies. A few, randomized, controlled trials comparing ultrasound- and nerve stimulation technique favour the benefit of ultrasound concerning success rate, sensory onset time, duration of block, patient satisfaction and quality of block.
The purpose of this study is to establish whether ultrasound technique has higher success rate, better patient satisfaction and higher cost-effectiveness compared to electrical nerve stimulation using popliteal, sciatic catheters for postoperative analgesia after foot and ankle surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Procedure: placement of popliteal catheterUltrasound guided placement of popliteal catheter |
| II | Experimental | Procedure: placement of popliteal catheterNerve stimulation guided placement of popliteal catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- elective posterior foot and/or ankle surgery
- calcaneus osteotomy
- subtalar arthrodesis
- total ankle arthroplasty
- ankle arthrodesis (non-arthroscopic) minimum age 18 years ASA I-III informed consent
Key exclusion criteria (13 listed)
- coagulation disorders
- infection in the region of needle insertion
- systemic infection
- preoperative sciatic nerve neuropathy
- preoperative motor or sensory deficit in the operative 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 |
|---|---|---|
| placement of popliteal catheterBolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h | Procedure or surgery | I, II |
Primary outcome
Success rate: post-operative analgesia
Time frame: First two post-operative days
7 secondary outcomes
Time consumption of catheter placement
Time frame: Before surgery
Duration of post-operative observation
Time frame: After surgery
Pain score
Time frame: First two post-operative days
Nausea score
Time frame: First two post-operative days
Sensory block
Time frame: First two post-operative days
Patient acceptance
Time frame: First two postoperative days
Cost-effectiveness
Time frame: Two days
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 Dec 2009.
- Derived from this study: PubMed 22855632Ehlers L, Jensen JM, Bendtsen TF. Cost-effectiveness of ultrasound vs nerve stimulation guidance for continuous sciatic nerve block. Br J Anaesth. 2012 Nov;109(5):804-8. doi: 10.1093/bja/aes259. Epub 2012 Jul 31.
- Derived from this study: PubMed 21425514Bendtsen TF, Nielsen TD, Rohde CV, Kibak K, Linde F. Ultrasound guidance improves a continuous popliteal sciatic nerve block when compared with nerve stimulation. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):181-4. doi: 10.1097/aap.0b013e31820d421f.
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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.
Thomas F Bendtsen, Ph.d. principal investigator
Department of Anesthesiology, Aarhus University Hospital, Norrebrogade, DK-8000 Aarhus C, Denmark
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 popliteal catheter in people with Pain, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 13 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 Dec 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 Denmark. 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?
Success rate: post-operative analgesia (time frame: First two post-operative days). 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 NCT00497276, which also lists 2 linked publications.
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 Dec 2009.