Hip FractureSSPSNCT01669018
Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift
A study testing Lumbar plexus block using LUT technique and Lumbar plexus block using SSPS technique in people with Hip Fracture, run by University of Aarhus at 1 site in Denmark.
Trial summary
Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a relevant technique in patients with severe cardiac comorbidity. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Lumbar plexus block using LUT technique and Lumbar plexus block using SSPS technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Dec 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written informed consent
- ASA I (American Society of Anesthesiologists physical status classification)
Who cannot join
- volunteers who are not able to cooperate
- volunteers who do not understand and speak danish
- daily use of analgesics
- allergy to local analgesics or contrast agents
- abuse of medicine or alcohol
- volunteers with technical impediments of the planned interventions
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesiology, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus
Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a relevant technique in patients with severe cardiac comorbidity. The technique is a safer alternative compared to general or spinal anesthesia in these fragile patients.
The most recognized technique with ultrasound guidance (Karmakars technique) is technically demanding and based on injection of local anesthetic relatively close to the exit of the spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal prompting a risk of low blood pressure. This may be fatal in high risk patients.
Read more
The investigators have developed a simple technique based on injection away from the spinal canal. The investigators expect minimal risk of spread of local anesthetic to the spinal canal with this technique.
This randomized, double blinded trial compares the new technique to the established technique of ultrasound guided blockade of the lumbar plexus.
The hypothesis is that the new technique has a higher success rate with reduced effect on blood pressure for ultrasound guided lumbar plexus block compared to the established technique.
- Conditions
- Hip Fracture
- Being tested
- Lumbar plexus block using LUT technique, Lumbar plexus block using SSPS technique
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar plexus block using LUT techniqueProcedure or surgery
Lumbar plexus block guided by ultrasound and nerve stimulation with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse processes of L3 and L4 until an appropriate neuromuscular response is produced.
Lumbar plexus block using SSPS techniqueProcedure or surgery
Lumbar plexus block guided by ultrasound and loss of resistance (LOR) with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse process of L5 and the sacral bone until an appropriate LOR is produced.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar ultrasound trident (LUT) | Active comparator | Lumbar plexus block using LUT technique Receives: Procedure: Lumbar plexus block using LUT technique |
| Supra Sacral Parallel Shift (SSPS) | Experimental | Lumbar plexus block using SSPS technique Receives: Procedure: Lumbar plexus block using SSPS technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1
Measured: 30 minutes after injection of local anesthetic
Secondary outcomes (10)
Plasma lidocaine level (mcg/mL)
Chromatography analysis
Measured: 0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic
Block performance time
Measured: From start of probe on the skin until injection of local anesthetic is completed
Patient satisfaction
Measured: Immediately after completion of injection of local anesthetic
Mean arterial blood pressure (MAP)
Absolute measure and relative change from pre-block measure
Measured: 5 minutes after completion of injection of local anesthetic
Cost-effectiveness
Estimated as incremental cost-effectiveness ratio
Measured: Block performance time period
Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)
Measured: 30 minutes after completed injection of local anesthetic
Sensory blockade of the femoral nerve (cold, warmth, touch, pain)
Measured: 30 minutes after completion of injection of local anesthetic
Motor blockade of the femoral nerve
Measured: 40 minutes after completion of injection of the local anesthetic
Motor blockade of the obturator nerve
Measured: 40 minutes after completion of injection of the local anesthetic
Perineural spread of local anesthetic (with contrast) estimated with MRI
Measured: 60 minutes after completion of injection of local anesthetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas F. Bendtsen, University of Aarhus
- Investigators
- Else Tønnesen, Professor, Study chair, Faculty of Health, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669018
- Sponsor's protocol ID
- SSPS-1-10-72-366-12
- Acronym
- SSPS
- Status last verified
- Jan 2013
- First submitted
- 16 Aug 2012
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus
- ClinicalTrials.gov ID
- NCT01669018
- Acronym / sponsor ID
- SSPS / SSPS-1-10-72-366-12
- Conditions
- Hip Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Aug 2012 (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.
Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a relevant technique in patients with severe cardiac comorbidity. The technique is a safer alternative compared to general or spinal anesthesia in these fragile patients.
The most recognized technique with ultrasound guidance (Karmakars technique) is technically demanding and based on injection of local anesthetic relatively close to the exit of the spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal prompting a risk of low blood pressure. This may be fatal in high risk patients.
The investigators have developed a simple technique based on injection away from the spinal canal. The investigators expect minimal risk of spread of local anesthetic to the spinal canal with this technique.
This randomized, double blinded trial compares the new technique to the established technique of ultrasound guided blockade of the lumbar plexus.
The hypothesis is that the new technique has a higher success rate with reduced effect on blood pressure for ultrasound guided lumbar plexus block compared to the established technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar ultrasound trident (LUT) | Active comparator | Procedure: Lumbar plexus block using LUT techniqueLumbar plexus block using LUT technique |
| Supra Sacral Parallel Shift (SSPS) | Experimental | Procedure: Lumbar plexus block using SSPS techniqueLumbar plexus block using SSPS technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- written informed consent
- ASA I (American Society of Anesthesiologists physical status classification)
Key exclusion criteria (6 listed)
- volunteers who are not able to cooperate
- volunteers who do not understand and speak danish
- daily use of analgesics
- allergy to local analgesics or contrast agents
- abuse of medicine or alcohol
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 |
|---|---|---|
| Lumbar plexus block using LUT techniqueLumbar plexus block guided by ultrasound and nerve stimulation with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse processes of L3 and L4 until an appropriate neuromuscular response is produced. | Procedure or surgery | Lumbar ultrasound trident (LUT) |
| Lumbar plexus block using SSPS techniqueLumbar plexus block guided by ultrasound and loss of resistance (LOR) with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse process of L5 and the sacral bone until an appropriate LOR is produced. | Procedure or surgery | Supra Sacral Parallel Shift (SSPS) |
Primary outcome
Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1
Time frame: 30 minutes after injection of local anesthetic
10 secondary outcomes
Plasma lidocaine level (mcg/mL)
Time frame: 0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic
Block performance time
Time frame: From start of probe on the skin until injection of local anesthetic is completed
Patient satisfaction
Time frame: Immediately after completion of injection of local anesthetic
Mean arterial blood pressure (MAP)
Time frame: 5 minutes after completion of injection of local anesthetic
Cost-effectiveness
Time frame: Block performance time period
Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)
Time frame: 30 minutes after completed injection of local anesthetic
Sensory blockade of the femoral nerve (cold, warmth, touch, pain)
Time frame: 30 minutes after completion of injection of local anesthetic
Motor blockade of the femoral nerve
Time frame: 40 minutes after completion of injection of the local anesthetic
Motor blockade of the obturator nerve
Time frame: 40 minutes after completion of injection of the local anesthetic
Perineural spread of local anesthetic (with contrast) estimated with MRI
Time frame: 60 minutes after completion of injection of local anesthetic
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 31 Jan 2013.
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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.
Else Tønnesen, Professor study chair
Faculty of Health, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar plexus block using LUT technique and Lumbar plexus block using SSPS technique in people with Hip Fracture, 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 2 inclusion and 6 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 31 Jan 2013. 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 of complete sensory blockade of dermatomes L2, L3, L4, L5, S1 (time frame: 30 minutes after injection of local anesthetic). 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 31 Jan 2013.