Knee Arthroscopy SurgeryNCT02020096
Ultrasound Plus Nerve Stimulator Versus Nerve Stimulator Guided Lumbar Plexus Block
A study testing Ultrasound and nerve stimulator guided lumbar plexus block and Nerve stimulator guided lumbar plexus block in people with Knee Arthroscopy Surgery, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block performance. It allows direct visualization of nerve structures, needle guidance in real-time to the target, and observation of local anesthetic diffusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Arthroscopy Surgery
- What is being tested?
- Ultrasound and nerve stimulator guided lumbar plexus block and Nerve stimulator guided lumbar plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Oct 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age 18-70yr
- American Society of Anesthesiologists physical status I-II
- Patients scheduled to undergo knee arthroscopy surgery
- Ultrasound visibility score equal or great than 10
Who cannot join
- Body mass index more than 35 kg/m²
- Pregnant or lactating women
- Allergy to local anesthetics
- Coagulopathy, on anticoagulants
- Malignancy or infection at puncture site
- Significant peripheral neuropathy or diabetic peripheral neuropathy
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- Language barrier
- Neuropsychiatric disorder
- Severe cardiac or respiratory diseases
- Pathology or previous surgery or trauma to the lower limb
- Analgesics intake, history of substance abuse
- History of spinal surgery or deformity
- Ultrasound visibility score less than 10
- Participating in the investigation of another experimental agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Ultrasound Plus Nerve Stimulator Guided Lumbar Plexus Block to Conventional Nerve Stimulator Guided Technique Using Winnie Approach
Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block performance. It allows direct visualization of nerve structures, needle guidance in real-time to the target, and observation of local anesthetic diffusion. Some case series have demonstrated significantly faster onset time for interscalene blocks, supraclavicular blocks and axillary brachial plexus blocks under ultrasound than with conventional techniques. Ultrasound guidance also enhances the quality of popliteal sciatic nerve block at the popliteal fossa compared with single injection, nerve stimulator-guided block using either a tibial or peroneal endpoint. Despite this impressive profile, the application of the ultrasound for lumbar plexus blocks has not been studied extensively. It is likely that lumbar plexus block (LPB) combined with either a sciatic nerve block or sedation or both is equivalent to general anesthesia and neuraxial anesthesia for knee arthroscopy. The lumbar plexus block is traditionally performed using surface anatomical landmarks and nerve stimulation. Ultrasound imaging of the anatomy relevant for LPB is challenging because of its deep anatomic location and the "acoustic shadow" of the overlying transverse processes. Recently, Karmakar M.K. etc. has demonstrated that a paramedian transverse scan (PMTS) of the lumbar paravertebral region with the ultrasound beam being insonated through the intertransverse space (ITS) and directed medially toward the intervertebral foramen (PMTS-ITS) may overcome the problem of the "acoustic shadow" and allow clear visualization of the anatomy relevant for LPB. However, the application of a PMTS-ITS used for lumbar plexus blocks has not been studied extensively and its advantages are not validated in a clinical study. Thus, we designed this prospective, randomized, subject and assessor blinded, parallel-group, active-controlled study to compare a PMTS ultrasound-guided lumbar plexus block combined with nerve stimulation and a conventional technique on time required to readiness for surgery in patients undergo knee arthroscopy surgery.
- Conditions
- Knee Arthroscopy Surgery
- Being tested
- Ultrasound and nerve stimulator guided lumbar plexus block, Nerve stimulator guided lumbar plexus block
- Keywords
- Lumbar plexus block, Ultrasound guidance, Nerve stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and nerve stimulator guided lumbar plexus blockProcedure or surgery
An insulated nerve block needle connected to a nerve stimulator that was delivering a current of 1.5 mA at a frequency of 2 Hz was then inserted in the long axis (in- plane) of the ultrasound transducer towards the the hypoechoic psoas compartment. If the quadriceps contraction which produces patella twitching was elicited with an initial current of 1.5mA,then the current should be reduced until contraction is still present between 0.3 to 0.5 mA .Afterward, the lumbar plexus nerve block was performed by using 30mL of 0.5% ropivacaine. Contraction should stop below a current of 0.3mA, otherwise intraneural needle position should be suspected.
Nerve stimulator guided lumbar plexus blockProcedure or surgery
The block was conducted following traditional Winnie approach. The accepted end point for the lumbar plexus is stimulation of the femoral nerve component, observed by contraction of the quadriceps muscle. Quadriceps contraction which produces patella twitching should be sought with an initial current of 1.5mA, and once elicited the current should be reduced until contraction is still present between 0.3 to 0.5 mA. Afterward, the lumbar plexus nerve block was performed by using 30mL of 0.5% ropivacaine. Contraction should stop below a current of 0.3mA, otherwise intraneural needle position should be suspected.
| Study group | Role | What they receive |
|---|---|---|
| U+N group | Experimental | Ultrasound and nerve stimulator guided lumbar plexus block combined with nerve stimulator guided sciatic block Receives: Procedure: Ultrasound and nerve stimulator guided lumbar plexus block |
| N group | Active comparator | Nerve stimulator guided lumbar plexus block combined with nerve stimulator guided sciatic nerve block Receives: Procedure: Nerve stimulator guided lumbar plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of sensory block to cold and pinprick
Onset time of sensory block (cold/pinprick), defined as time interval from completion of local anesthetic injection to the achievement of complete sensory block (defined as no sensation in three major branches including the femoral nerve, the lateral femoral cutaneous nerve and the obturator nerve) .
Measured: up to 40 min after ropivacaine injection
Secondary outcomes (8)
Total ultrasound visibility score (UVS)
The independent observer attempted to visualize 10 paravertebral structures in images of the ultrasound scans from the patients
Measured: 30 min before and 5 min after lumbar plexus block
Performance time of block
Performance time of block is the preparing time and procedure time. Preparing time (defined as the time from the beginning of the sterile preparation right before the first needle contact with the skin). Procedure time (time between the insertion of the needle and the end of local anesthetic injection)
Measured: up to 20 min after needle insertion
Number of needle passes during block
Number of needle passes during block
Measured: up to 20min after needle insertion
Minimal stimulating current of the needle
All peripheral nerve blocks were performed by the same anesthesiologist with an 100-mm insulated stimulating needle attached to a nerve stimulator. The intensity of the stimulating current, initially set to deliver 1 to 1.5 mA (0.1ms, 2Hz), was gradually decreased to <0.5 mA while the appropriate motor response was maintained.
For sciatic block, the targeted evoked motor response was plantar flexion of the foot. For lumbar plexus block, quadriceps muscle motor response was targeted.Contraction should stop below a current of 0.2mA, otherwise intraneural needle position should be suspected and the needle should be withdraw and readjusted. The Minimal stimulating current ( intensity of the current when the needle was considered to be adequately positioned) finally demonstrated on nerve stimulator was recorded, then ropivacaine was injected slowly after careful intermittent aspirations.
Measured: up to 20min after needle insertion
Onset time of motor block
onset time of motor block, defined as time interval from completion of local anesthetic injection to the achievement of satisfied motor block (defined as a Modified Bromage scale equal to 3).
Measured: up to 40min after ropivacaine injection
Incidence of paresthesia during block
Incidence of paresthesia during block reported by patients
Measured: up to 20min after needle insertion
Incidence of accidental vascular puncture
Incidence of accidental vascular puncture, defined as blood by aspiration.
Measured: up to 20min after needle insertion
Changes of muscle strength of quadriceps femoris and adductors
Muscle strength of quadriceps femoris and adductors was measured with hand-held dynamometer (HHD, Hogan Health Industries, MicroFET3) during knee extension and hip adduction.
Measured: up to 40min after ropivacaine injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroscopy SurgeryStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, MD., PhD., Principal investigator, Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyYuke Tian, MD., PhD., Study chair, Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020096
- Sponsor's protocol ID
- TJMZK20131001
- Status last verified
- Nov 2019
- First submitted
- 28 Nov 2013
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Ultrasound Plus Nerve Stimulator Guided Lumbar Plexus Block to Conventional Nerve Stimulator Guided Technique Using Winnie Approach
- ClinicalTrials.gov ID
- NCT02020096
- Acronym / sponsor ID
- TJMZK20131001
- Conditions
- Knee Arthroscopy Surgery
- Keywords
- Lumbar plexus block, Ultrasound guidance, Nerve stimulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Dec 2013 (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.
Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block performance. It allows direct visualization of nerve structures, needle guidance in real-time to the target, and observation of local anesthetic diffusion. Some case series have demonstrated significantly faster onset time for interscalene blocks, supraclavicular blocks and axillary brachial plexus blocks under ultrasound than with conventional techniques. Ultrasound guidance also enhances the quality of popliteal sciatic nerve block at the popliteal fossa compared with single injection, nerve stimulator-guided block using either a tibial or peroneal endpoint. Despite this impressive profile, the application of the ultrasound for lumbar plexus blocks has not been studied extensively. It is likely that lumbar plexus block (LPB) combined with either a sciatic nerve block or sedation or both is equivalent to general anesthesia and neuraxial anesthesia for knee arthroscopy. The lumbar plexus block is traditionally performed using surface anatomical landmarks and nerve stimulation. Ultrasound imaging of the anatomy relevant for LPB is challenging because of its deep anatomic location and the "acoustic shadow" of the overlying transverse processes. Recently, Karmakar M.K. etc. has demonstrated that a paramedian transverse scan (PMTS) of the lumbar paravertebral region with the ultrasound beam being insonated through the intertransverse space (ITS) and directed medially toward the intervertebral foramen (PMTS-ITS) may overcome the problem of the "acoustic shadow" and allow clear visualization of the anatomy relevant for LPB. However, the application of a PMTS-ITS used for lumbar plexus blocks has not been studied extensively and its advantages are not validated in a clinical study. Thus, we designed this prospective, randomized, subject and assessor blinded, parallel-group, active-controlled study to compare a PMTS ultrasound-guided lumbar plexus block combined with nerve stimulation and a conventional technique on time required to readiness for surgery in patients undergo knee arthroscopy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U+N group | Experimental | Procedure: Ultrasound and nerve stimulator guided lumbar plexus blockUltrasound and nerve stimulator guided lumbar plexus block combined with nerve stimulator guided sciatic block |
| N group | Active comparator | Procedure: Nerve stimulator guided lumbar plexus blockNerve stimulator guided lumbar plexus block combined with nerve stimulator guided sciatic nerve block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- Age 18-70yr
- American Society of Anesthesiologists physical status I-II
- Patients scheduled to undergo knee arthroscopy surgery
- Ultrasound visibility score equal or great than 10
Key exclusion criteria (14 listed)
- Body mass index more than 35 kg/m²
- Pregnant or lactating women
- Allergy to local anesthetics
- Coagulopathy, on anticoagulants
- Malignancy or infection at puncture site
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 |
|---|---|---|
| Ultrasound and nerve stimulator guided lumbar plexus blockAn insulated nerve block needle connected to a nerve stimulator that was delivering a current of 1.5 mA at a frequency of 2 Hz was then inserted in the long axis (in- plane) of the ultrasound transducer towards the the hypoechoic psoas compartment. If the quadriceps contraction which produces patella twitching was elicited with an initial current of 1.5mA,then the current should be reduced until contraction is still present between 0.3 to 0.5 mA .Afterward, the lumbar plexus nerve block was performed by using 30mL of 0.5% ropivacaine. Contraction should stop below a current of 0.3mA, otherwise intraneural needle position should be suspected. | Procedure or surgery | U+N group |
| Nerve stimulator guided lumbar plexus blockThe block was conducted following traditional Winnie approach. The accepted end point for the lumbar plexus is stimulation of the femoral nerve component, observed by contraction of the quadriceps muscle. Quadriceps contraction which produces patella twitching should be sought with an initial current of 1.5mA, and once elicited the current should be reduced until contraction is still present between 0.3 to 0.5 mA. Afterward, the lumbar plexus nerve block was performed by using 30mL of 0.5% ropivacaine. Contraction should stop below a current of 0.3mA, otherwise intraneural needle position should be suspected. | Procedure or surgery | N group |
Primary outcome
Onset time of sensory block to cold and pinprick
Time frame: up to 40 min after ropivacaine injection
Onset time of sensory block (cold/pinprick), defined as time interval from completion of local anesthetic injection to the achievement of complete sensory block (defined as no sensation in three major branches including the femoral nerve, the lateral femoral cutaneous nerve and the obturator nerve) .
8 secondary outcomes
Total ultrasound visibility score (UVS)
Time frame: 30 min before and 5 min after lumbar plexus block
Performance time of block
Time frame: up to 20 min after needle insertion
Number of needle passes during block
Time frame: up to 20min after needle insertion
Minimal stimulating current of the needle
Time frame: up to 20min after needle insertion
Onset time of motor block
Time frame: up to 40min after ropivacaine injection
Incidence of paresthesia during block
Time frame: up to 20min after needle insertion
Incidence of accidental vascular puncture
Time frame: up to 20min after needle insertion
Changes of muscle strength of quadriceps femoris and adductors
Time frame: up to 40min after ropivacaine injection
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 14 Nov 2019.
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.
Wei Mei, MD., PhD. principal investigator
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Yuke Tian, MD., PhD. study chair
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and nerve stimulator guided lumbar plexus block and Nerve stimulator guided lumbar plexus block in people with Knee Arthroscopy Surgery, run by Huazhong University of Science and Technology at 1 site in China.
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 14 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 14 Nov 2019. 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 China. 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 sensory block to cold and pinprick (time frame: up to 40 min after ropivacaine injection). 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 14 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.