Lumbar Plexus BlockadeNCT02982031
A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade
A study testing paramedian transverse scan in people with Lumbar Plexus Blockade, run by Mahidol University at 1 site in Thailand.
Trial summary
The primary objective of this study was to compare ultrasound visibility of the lumbar plexus at the intertransverse space between paramedian transverse scan and shamrock technique. Moreover obtaining a clear image of relevant structures is imperative. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Plexus Blockade
- What is being tested?
- paramedian transverse scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2016to Sep 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteer, age >/= 18
Who cannot join
- spinal deformity and history of previous back or spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study was to compare ultrasound visibility of the lumbar plexus at the intertransverse space between paramedian transverse scan and shamrock technique. Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary objective was to assess ultrasound visibility of each relevant structure and overall visibility between these two methods.
Read the detailed description
Background: Ultrasound-guided lumbar plexus block (USG LPB) is regarded as a form of advanced ultrasound-guided regional anesthesia (USGRA). One of the key challenges of USG LPB is visualization of the lumbar plexus. That are currently in use for ultrasound-guided lumbar plexus blockade - paramedian transverse scan (PMTS) and shamrock technique.
Method: Twenty-three healthy adult volunteers aged ≥ 18 years were enrolled in this prospective cohort study. Ultrasound visualization results were compared between methods.
- Conditions
- Lumbar Plexus Blockade
- Being tested
- shamrock, paramedian transverse scan
- Keywords
- Ultrasound-guided lumbar plexus blockade, Shamrock technique, Paramedian transverse scan, USG LPB, USGRA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shamrockProcedure or surgery
This scanning technique is performed in the lateral decubitus position with the side of interest facing upwards. The transducer is placed in the transverse plane on the flank of the patient cranially to the iliac crest. The quadratus lumborum muscle is identified medial to the aponeurosis of the transversus abdominis muscle. With the psoas muscle anterior to the transverse process, the erector spinae muscle posterior to the transverse process, and the quadratus lumborum muscle attached to the apex of the transverse process of L4.
paramedian transverse scanProcedure or surgery
The ultrasound transducer is positioned 4 cm lateral to the midline along the intercristal line and just above the iliac crest. The transducer is also directed slightly medially.
| Study group | Role | What they receive |
|---|---|---|
| shamrock | Sham comparator | shamrock: both left and right sided scan,both intertransverse and transverse process window Receives: Procedure: shamrock |
| paramedian transverse scan | Active comparator | paramedian transverse scan (PMTS): both left and right, both intertransverse and transverse process window Receives: Procedure: paramedian transverse scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Video (VDO) loops visualization of lumbar plexus
Percentage of Video (VDO) loops visualization of lumbar plexus comparing between two techniques
Measured: 1 month
Secondary outcomes (2)
Ultrasound visibility score of each relevant structures
10 structures: Erector spinae muscle, Quadratus lumborum muscle, Psoas muscle, Vertebral body, Inferior vena cava, Articular process of the lumbar vertebra, Lumbar paravertebral space, lumbar nerve root, Lumbar plexus nerve, Psoas compartment Using 4-point Likert scale (0, not visible; 1, hardly visible; 2, well visible; 3, very well visible)
Measured: 1 month
Overall ultrasound visibility score of 10 structures
Sum of ultrasound visibility score of 10 relevant structures: Erector spinae muscle, Quadratus lumborum muscle, Psoas muscle, Vertebral body, Inferior vena cava, Articular process of the lumbar vertebra, Lumbar paravertebral space, lumbar nerve root, Lumbar plexus nerve, Psoas compartment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Plexus BlockadeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pawinee Pawinee, M.D, Principal investigator, 66864001721
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982031
- Sponsor's protocol ID
- 302/2559(EC4)
- Status last verified
- Dec 2016
- First submitted
- 18 Sep 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade
- ClinicalTrials.gov ID
- NCT02982031
- Acronym / sponsor ID
- 302/2559(EC4)
- Conditions
- Lumbar Plexus Blockade
- Keywords
- Ultrasound-guided lumbar plexus blockade, Shamrock technique, Paramedian transverse scan, USG LPB, USGRA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Dec 2016 (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 primary objective of this study was to compare ultrasound visibility of the lumbar plexus at the intertransverse space between paramedian transverse scan and shamrock technique. Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary objective was to assess ultrasound visibility of each relevant structure and overall visibility between these two methods.
Detailed description
Background: Ultrasound-guided lumbar plexus block (USG LPB) is regarded as a form of advanced ultrasound-guided regional anesthesia (USGRA). One of the key challenges of USG LPB is visualization of the lumbar plexus. That are currently in use for ultrasound-guided lumbar plexus blockade - paramedian transverse scan (PMTS) and shamrock technique.
Method: Twenty-three healthy adult volunteers aged ≥ 18 years were enrolled in this prospective cohort study. Ultrasound visualization results were compared between methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shamrock | Sham comparator | Procedure: shamrockshamrock: both left and right sided scan,both intertransverse and transverse process window |
| paramedian transverse scan | Active comparator | Procedure: paramedian transverse scanparamedian transverse scan (PMTS): both left and right, both intertransverse and transverse process window |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteer, age >/= 18
Key exclusion criteria (1 listed)
- spinal deformity and history of previous back or spine surgery
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 |
|---|---|---|
| shamrockThis scanning technique is performed in the lateral decubitus position with the side of interest facing upwards. The transducer is placed in the transverse plane on the flank of the patient cranially to the iliac crest. The quadratus lumborum muscle is identified medial to the aponeurosis of the transversus abdominis muscle. With the psoas muscle anterior to the transverse process, the erector spinae muscle posterior to the transverse process, and the quadratus lumborum muscle attached to the apex of the transverse process of L4. | Procedure or surgery | shamrock |
| paramedian transverse scanThe ultrasound transducer is positioned 4 cm lateral to the midline along the intercristal line and just above the iliac crest. The transducer is also directed slightly medially. | Procedure or surgery | paramedian transverse scan |
Primary outcome
Percentage of Video (VDO) loops visualization of lumbar plexus
Time frame: 1 month
Percentage of Video (VDO) loops visualization of lumbar plexus comparing between two techniques
2 secondary outcomes
Ultrasound visibility score of each relevant structures
Time frame: 1 month
Overall ultrasound visibility score of 10 structures
Time frame: 1 month
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 5 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Pawinee Pawinee, M.D principal investigator
66864001721
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paramedian transverse scan in people with Lumbar Plexus Blockade, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 1 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 5 Dec 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
Percentage of Video (VDO) loops visualization of lumbar plexus (time frame: 1 month). 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 5 Dec 2016.