Hip FracturesPhase 1NCT02593370
Suprasacral Parallel Shift - Ultrasound/MR Image Fusion Guided Lumbosacral Plexus Block
A Phase 1 study testing Lidocaine-epinephrine added gadoterate meglumine in people with Hip Fractures and Anesthesia Local, run by Thomas F. Bendtsen at 1 site in Denmark.
Trial summary
The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Anesthesia Local, Pain, Perioperative
- What is being tested?
- Lidocaine-epinephrine added gadoterate meglumine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Jan 2016
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Volunteers who has given their written and oral informed consent to participate in the study after having fully understood the content and the limitations of the protocol.
- Normal healthy person (American Society of Anesthesiology [ASA] Classification I)
Who cannot join
- Volunteers not able to cooperate in the study
- Volunteers not able to understand or speak Danish
- Daily use of analgesics
- Allergy against the medicines used in the study
- Drug abuse (according to the investigator's judgement)
- Alcohol consumption greater than the recommendations of the Danish National Board of Health
Show all 9Show fewer
- Contraindication for MRI including pregnancy
- Volunteer in whom nerve blocks are not possible due to technical reasons
- Volunteer who are incompetent (ie. surrogate consent is not accepted)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesiology and Intensive Care, Aarhus University Hospital
Aarhus C, 8000
About this study
The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.
Read the detailed description
The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a one-injection nerve block of the lower part of the lumbar plexus and the upper part of the sacral plexus (Suprasacral Parallel Shift, SSPS) to achieve analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 with SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound by estimating sensory block of in healthy volunteers by estimating the sensory block of dermatomes of the terminal nerves in healthy volunteers.
The secondary objective is to estimate a) preparation and b) procedure time, c) injection site and d) depth, e) discomfort, f) change in MAP, g) plasma lidocaine pharmacokinetics, h) motor and i) sensory block, j) perineural and k) epidural spread of lidocaine-epinephrine added gadotorate meglumine on MRI, and l) cost-effectiveness of SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound.
The investigators hypothesize that block success is higher for SSPS guided by ultrasound/MR image fusion than for SSPS guided by ultrasound.
- Conditions
- Hip Fractures, Anesthesia Local, Pain, Perioperative
- Being tested
- Lidocaine-epinephrine added gadoterate meglumine
- Keywords
- Hip surgery anesthesia, Perioperative analgesia
- Medical subject headings
- Hip Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine-epinephrine added gadoterate meglumineDrug
| Study group | Role | What they receive |
|---|---|---|
| Suprasacral Parallel Shift guided by US/MR image fusion | Experimental | Use of ultrasound/MR image fusion guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine). Receives: Drug: Lidocaine-epinephrine added gadoterate meglumine |
| Suprasacral Parallel Shift guided by US | Active comparator | Use of ultrasound guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine). Receives: Drug: Lidocaine-epinephrine added gadoterate meglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success
Block success of the clinical relevant lumbosacral nerves that innervate the hip joint capsule estimated as significant motor block of the obturator nerve, the femoral nerve, and the lumbosacral trunk. Motor block is a significant proxy marker of sensory block. Motor block (muscle strength, mmHg) is assessed with a handheld dynamometer.
Measured: Estimated 40 min after completed intervention. Presented 10 months after last patient last visit (LVLP).
Secondary outcomes (11)
Plasma lidocaine
Measured: Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after intervention. Presented 10 months after LVLP
Time for preparation
Time for preparation in seconds is defined as the time of placement of the volunteer on the bed until the end of pre-ultrasound scanning
Measured: Estimated prior to intervention. Presented 10 months after LVLP
Block procedure time
Block procedure time in seconds is defined as the time of the placement of the ultrasound probe on the skin to until the block needle is pulled out after injection of local anesthetics
Measured: Estimated during intervention. Presented 10 months after LVLP
Injection site
Measured: Estimated at the end of the intervention. Presented 10 months after LVLP
Block needle depth
Measured: Estimated at the end of the intervention. Presented 10 months after LVLP
Discomfort
Estimated on numeric rating scale 0-10
Measured: Estimated immediately after the intervention. Presented 10 months after LVLP
Mean arterial pressure change
Measured: Mean arterial pressure is measured prior intervention and 5 min after intervention. Presented 10 months after LVLP
Sensory (cold, warm, touch, pain) block of the dermatomes T12-S3 and the lateral femoral cutaneous nerve
Measured: Estimated 50 min after intervention. Presented 10 months after LVLP
Perineural spread of local anesthetics added gadoterate meglumine
Measured: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP
Epidural spread of local anesthetics added gadoterate meglumine
Measured: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP
Cost-effectiveness (ICER)
ICER is estimated as the difference in mean marginal cost of the blocks.
Measured: Calculated after LVLP. Presented 10 months after the last visit of the last volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas F. Bendtsen
- Sponsor type
- University, hospital or other
- Collaborators
- AP Moeller Foundation, Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Thomas F. Bendtsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593370
- Sponsor's protocol ID
- AUH-TFB-SSPS
- Status last verified
- Feb 2016
- First submitted
- 28 Oct 2015
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Strid JM, Pedersen EM, Al-Karradi SN, Bendtsen MA, Bjorn S, Dam M, Daugaard M, Hansen MS, Linnet KD, Borglum J, Soballe K, Bendtsen TF. Real-Time Ultrasound/MRI Fusion for Suprasacral Parallel Shift Approach to Lumbosacral Plexus Blockade and Analysis of Injectate Spread: An Exploratory Randomized Controlled Trial. Biomed Res Int. 2017;2017:1873209. doi: 10.1155/2017/1873209. Epub 2017 Mar 15.
PubMed 28396863
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprasacral Parallel Shift - Ultrasound/MR Image Fusion Guided Lumbosacral Plexus Block
- ClinicalTrials.gov ID
- NCT02593370
- Acronym / sponsor ID
- AUH-TFB-SSPS
- Conditions
- Hip Fractures, Anesthesia Local, Pain, Perioperative
- Keywords
- Hip surgery anesthesia, Perioperative analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Thomas F. BendtsenUniversity, hospital or other
- Collaborators
- AP Moeller Foundation, Aarhus University Hospital
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Nov 2015 (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 main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.
Detailed description
The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a one-injection nerve block of the lower part of the lumbar plexus and the upper part of the sacral plexus (Suprasacral Parallel Shift, SSPS) to achieve analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 with SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound by estimating sensory block of in healthy volunteers by estimating the sensory block of dermatomes of the terminal nerves in healthy volunteers.
The secondary objective is to estimate a) preparation and b) procedure time, c) injection site and d) depth, e) discomfort, f) change in MAP, g) plasma lidocaine pharmacokinetics, h) motor and i) sensory block, j) perineural and k) epidural spread of lidocaine-epinephrine added gadotorate meglumine on MRI, and l) cost-effectiveness of SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound.
The investigators hypothesize that block success is higher for SSPS guided by ultrasound/MR image fusion than for SSPS guided by ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprasacral Parallel Shift guided by US/MR image fusion | Experimental | Drug: Lidocaine-epinephrine added gadoterate meglumineUse of ultrasound/MR image fusion guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine). |
| Suprasacral Parallel Shift guided by US | Active comparator | Drug: Lidocaine-epinephrine added gadoterate meglumineUse of ultrasound guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Volunteers who has given their written and oral informed consent to participate in the study after having fully understood the content and the limitations of the protocol.
- Normal healthy person (American Society of Anesthesiology [ASA] Classification I)
Key exclusion criteria (9 listed)
- Volunteers not able to cooperate in the study
- Volunteers not able to understand or speak Danish
- Daily use of analgesics
- Allergy against the medicines used in the study
- Drug abuse (according to the investigator's judgement)
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 |
|---|---|---|
| Lidocaine-epinephrine added gadoterate meglumine | Drug | Suprasacral Parallel Shift guided by US, Suprasacral Parallel Shift guided by US/MR image fusion |
Primary outcome
Block success
Time frame: Estimated 40 min after completed intervention. Presented 10 months after last patient last visit (LVLP).
Block success of the clinical relevant lumbosacral nerves that innervate the hip joint capsule estimated as significant motor block of the obturator nerve, the femoral nerve, and the lumbosacral trunk. Motor block is a significant proxy marker of sensory block. Motor block (muscle strength, mmHg) is assessed with a handheld dynamometer.
11 secondary outcomes
Plasma lidocaine
Time frame: Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after intervention. Presented 10 months after LVLP
Time for preparation
Time frame: Estimated prior to intervention. Presented 10 months after LVLP
Block procedure time
Time frame: Estimated during intervention. Presented 10 months after LVLP
Injection site
Time frame: Estimated at the end of the intervention. Presented 10 months after LVLP
Block needle depth
Time frame: Estimated at the end of the intervention. Presented 10 months after LVLP
Discomfort
Time frame: Estimated immediately after the intervention. Presented 10 months after LVLP
Mean arterial pressure change
Time frame: Mean arterial pressure is measured prior intervention and 5 min after intervention. Presented 10 months after LVLP
Sensory (cold, warm, touch, pain) block of the dermatomes T12-S3 and the lateral femoral cutaneous nerve
Time frame: Estimated 50 min after intervention. Presented 10 months after LVLP
Perineural spread of local anesthetics added gadoterate meglumine
Time frame: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP
Epidural spread of local anesthetics added gadoterate meglumine
Time frame: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP
Cost-effectiveness (ICER)
Time frame: Calculated after LVLP. Presented 10 months after the last visit of the last volunteer
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 12 Feb 2016.
- Derived from this study: PubMed 28396863Strid JM, Pedersen EM, Al-Karradi SN, Bendtsen MA, Bjorn S, Dam M, Daugaard M, Hansen MS, Linnet KD, Borglum J, Soballe K, Bendtsen TF. Real-Time Ultrasound/MRI Fusion for Suprasacral Parallel Shift Approach to Lumbosacral Plexus Blockade and Analysis of Injectate Spread: An Exploratory Randomized Controlled Trial. Biomed Res Int. 2017;2017:1873209. doi: 10.1155/2017/1873209. Epub 2017 Mar 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine-epinephrine added gadoterate meglumine in people with Hip Fractures and Anesthesia Local, run by Thomas F. Bendtsen 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 3 inclusion and 9 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 12 Feb 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Block success (time frame: Estimated 40 min after completed intervention. Presented 10 months after last patient last visit (LVLP).). 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 NCT02593370, which also lists 1 linked publication.
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 12 Feb 2016.