AnesthesiaNCT03315481
Ultrasound Guided Repositioning of a New Suture-Method Catheter for Adductor Canal Block
A study testing SAX catheter insertion and LAX catheter insertion in people with Anesthesia and Pain, Postoperative, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
This is a randomized clinical trial in healthy volunteers. 12 volunteers will have suture-method catheters placed in the adductor canal of each leg using the long-axis plane and short-axis plane technique. The investigators will inject LA in both catheters to confirm correct position. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pain, Postoperative, Pain
- What is being tested?
- SAX catheter insertion and LAX catheter insertion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Mar 2017to 18 Apr 2017
- 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
- Male or female ≥18 years of age.
- ASA classification ≤ II.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Previous surgery or ongoing pain or other disability of investigated region resulting in sensory or neurologic deficits in the investigated region.
- Allergy to LA.
- Pregnancy (all female participants will be tested for urine hCG), breastfeeding, or unwilling to practice birth control during participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Repositioning of a New Suture-method Catheter for Adductor Canal Block - a Randomized Study in Healthy Volunteers
This is a randomized clinical trial in healthy volunteers. 12 volunteers will have suture-method catheters placed in the adductor canal of each leg using the long-axis plane and short-axis plane technique. The investigators will inject LA in both catheters to confirm correct position. Following return of cold sensation the catheter is then displaced intentionally. The orifice is identified by injection of isotonic saline to ensure a proper displacement (spread outside of the adductor canal) and the distance from the delivery orifice of the catheter to the adductor canal is noted. A second investigator will assess distance from the LA delivery orifice of the catheter to the adductor canal using hydrodissection with isotonic saline to pinpoint the delivery orifice and subsequently reposition the catheter to obtain LA spread within the adductor canal. Successful repositioning is defined as a combination of LA spread within the adductor canal and loss of cold sensation on the medial part of the lower leg.
Read the detailed description
The study objective is to investigate whether it is possible to reposition a displaced suture-method catheter using ultrasound.
A peripheral nerve catheter will be inserted on each side under US guidance. An investigator will insert one catheter in the short-axis plane of the adductor canal using an in plane technique: The needle is inserted through the vastus medialis into the adductor canal and exits superficial to the femoral artery through the sartorius muscle.
The second catheter is inserted from proximal to distal direction in the long-axis plane using a combination of in-plane and out-of-plane techniques.
10mL of isotonic saline is used for hydro-dissection for both catheter insertions to facilitate placement. Both catheters are injected with 15 mL LA with an immediate assessment of the spread being within or outside the adductor canal.
Loss of cold sensation in the cutaneous saphenous nerve innervation area will be evaluated 15 minutes after injection by another investigator, who is blinded to allocation and randomization.
Following return of normal sensory function the catheter is then intentionally displaced at least 2 cm outside the adductor canal in the direction of the entry or exit site according to randomization. The distance from the LA delivery orifice of the catheter to the adductor canal is noted. Adequate displacement requires that injection of isotonic saline does not result in spread within the adductor canal.
A third investigator will assess distance from the LA delivery orifice of the catheter to the adductor canal and subsequently reposition the catheter using saline to pinpoint location of the delivery orifice. Once the catheter is repositioned LA is injected. The US scan during LA injection is performed with a fourth investigator present to evaluate for satisfactory spread within the adductor canal. The 2 investigators will not communicate regarding the assessment of spread within the adductor canal.
Evaluation of cold sensation on the medial part of the lower leg is performed 15 minutes after 15mL LA (lidocaine 10 mg/mL) injection by investigator 2. The catheters are then removed and the study is completed.
Distance from catheter delivery orifices to the adductor canal is defined as following:
Distance from the LA delivery orifice to the fascia surrounding the adductor canal is noted in the short axis group. The distance from the LA delivery orifice to the penetration of the aponeurosis lying just below the sartorius muscle is noted in the long axis group. Both represent anatomical reference points for the adductor canal.
Satisfactory spread within the adductor canal is defined as following:
The LA injection spreads deeper along the lateral side of the femoral artery, observed in the two-dimensional plane while producing minimal displacement of the roof and the overlying sartorius muscle.
The injection may spread occasionally superficially over the femoral artery within the canal and will then force the artery deeper. If the injection spreads more medially and superficially over the saphenous nerve and femoral artery in an anterolateral to posteromedial direction, initially resembling the injections within the adductor canal but separates the sartorius muscle from the femoral artery by lifting the sartorius muscle medially off the hyperechoic roof of the adductor canal it is considered not to spread within the adductor canal.13
Successful primary placement and subsequent repositioning is defined as the combination of satisfactory spread within the adductor canal (assessed using SAX visualization of the adductor canal for both catheters) and loss of cold sensation.
- Conditions
- Anesthesia, Pain, Postoperative, Pain, Pain, Joint
- Being tested
- SAX catheter insertion, LAX catheter insertion
- Medical subject headings
- Pain, Postoperative, Pain, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAX catheter insertionProcedure or surgery
Suture-method catheter inserted in the short axis of the adductor canal
LAX catheter insertionProcedure or surgery
Suture-method catheter inserted in the long axis of the adductor canal
| Study group | Role | What they receive |
|---|---|---|
| SAX catheter insertion | Active comparator | Ultrasound guided cather insertion in the short axis (SAX) of the adductor canal. Injection of lidocaine through the catheter Receives: Procedure: SAX catheter insertion |
| LAX catheter insertion | Active comparator | Ultrasound guided cather insertion in the long axis (LAX) of the adductor canal. Injection of lidocaine through the catheter Receives: Procedure: LAX catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful repositioning
Defined as a combination of spread within the adductor canal and loss of cold sensation on the medial part of the lower leg after repositioning and second LA injection.
- investigator 3 will evaluate spread and investigator 2 will evaluate cold sensation
Measured: 15 min after second injection
Secondary outcomes (3)
Successful primary placement
Defined as a combination of spread within the adductor canal and loss of cold sensation after initial LA injection - investigator 1 will evaluate spread and investigator 2 will evaluate cold sensation
Measured: 15 min after first injection
Estimation of Limits of Agreement
in evaluation of displacement distance of the catheter between investigator 1 and 3
Measured: within 15 minutes, after displacement/repositioning.(recorded by after displacement and repeated just before attempted repositioning)
Interrater agreement for satisfactory spread within the adductor Canal, (Cohen's Kappa)
Investigator 3 and 4 will independently evaluate spread within the adductor canal.
Measured: recorded immediately after second LA injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start7 Mar 2017
- Primary completion18 Apr 2017
- Study completion18 Apr 2017
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 AnesthesiaStudies 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized clinical trial in healthy volunteers. 12 volunteers will have suture-method catheters placed in the adductor canal of each leg using the long-axis plane and short-axis plane technique
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias S Lyngeraa, MD, Principal investigator, Research Unit, Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital Hilleroed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315481
- Sponsor's protocol ID
- H-16029530
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jordahn ZM, Lyngeraa TS, Grevstad U, Rothe C, Lundstrom LH, Lange KHW. Ultrasound guided repositioning of a new suture-method catheter for adductor canal block - a randomized pilot study in healthy volunteers. BMC Anesthesiol. 2018 Oct 24;18(1):150. doi: 10.1186/s12871-018-0615-4.
PubMed 30355334
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Repositioning of a New Suture-method Catheter for Adductor Canal Block - a Randomized Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03315481
- Acronym / sponsor ID
- H-16029530
- Conditions
- Anesthesia, Pain, Postoperative, Pain, Pain, Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 20 Oct 2017 (actual)
- 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.
This is a randomized clinical trial in healthy volunteers. 12 volunteers will have suture-method catheters placed in the adductor canal of each leg using the long-axis plane and short-axis plane technique. The investigators will inject LA in both catheters to confirm correct position. Following return of cold sensation the catheter is then displaced intentionally. The orifice is identified by injection of isotonic saline to ensure a proper displacement (spread outside of the adductor canal) and the distance from the delivery orifice of the catheter to the adductor canal is noted. A second investigator will assess distance from the LA delivery orifice of the catheter to the adductor canal using hydrodissection with isotonic saline to pinpoint the delivery orifice and subsequently reposition the catheter to obtain LA spread within the adductor canal. Successful repositioning is defined as a combination of LA spread within the adductor canal and loss of cold sensation on the medial part of the lower leg.
Detailed description
The study objective is to investigate whether it is possible to reposition a displaced suture-method catheter using ultrasound.
A peripheral nerve catheter will be inserted on each side under US guidance. An investigator will insert one catheter in the short-axis plane of the adductor canal using an in plane technique: The needle is inserted through the vastus medialis into the adductor canal and exits superficial to the femoral artery through the sartorius muscle.
The second catheter is inserted from proximal to distal direction in the long-axis plane using a combination of in-plane and out-of-plane techniques.
10mL of isotonic saline is used for hydro-dissection for both catheter insertions to facilitate placement. Both catheters are injected with 15 mL LA with an immediate assessment of the spread being within or outside the adductor canal.
Loss of cold sensation in the cutaneous saphenous nerve innervation area will be evaluated 15 minutes after injection by another investigator, who is blinded to allocation and randomization.
Following return of normal sensory function the catheter is then intentionally displaced at least 2 cm outside the adductor canal in the direction of the entry or exit site according to randomization. The distance from the LA delivery orifice of the catheter to the adductor canal is noted. Adequate displacement requires that injection of isotonic saline does not result in spread within the adductor canal.
A third investigator will assess distance from the LA delivery orifice of the catheter to the adductor canal and subsequently reposition the catheter using saline to pinpoint location of the delivery orifice. Once the catheter is repositioned LA is injected. The US scan during LA injection is performed with a fourth investigator present to evaluate for satisfactory spread within the adductor canal. The 2 investigators will not communicate regarding the assessment of spread within the adductor canal.
Evaluation of cold sensation on the medial part of the lower leg is performed 15 minutes after 15mL LA (lidocaine 10 mg/mL) injection by investigator 2. The catheters are then removed and the study is completed.
Distance from catheter delivery orifices to the adductor canal is defined as following:
Distance from the LA delivery orifice to the fascia surrounding the adductor canal is noted in the short axis group. The distance from the LA delivery orifice to the penetration of the aponeurosis lying just below the sartorius muscle is noted in the long axis group. Both represent anatomical reference points for the adductor canal.
Satisfactory spread within the adductor canal is defined as following:
The LA injection spreads deeper along the lateral side of the femoral artery, observed in the two-dimensional plane while producing minimal displacement of the roof and the overlying sartorius muscle.
The injection may spread occasionally superficially over the femoral artery within the canal and will then force the artery deeper. If the injection spreads more medially and superficially over the saphenous nerve and femoral artery in an anterolateral to posteromedial direction, initially resembling the injections within the adductor canal but separates the sartorius muscle from the femoral artery by lifting the sartorius muscle medially off the hyperechoic roof of the adductor canal it is considered not to spread within the adductor canal.13
Successful primary placement and subsequent repositioning is defined as the combination of satisfactory spread within the adductor canal (assessed using SAX visualization of the adductor canal for both catheters) and loss of cold sensation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial in healthy volunteers. 12 volunteers will have suture-method catheters placed in the adductor canal of each leg using the long-axis plane and short-axis plane technique
| Arm | Type | Receives |
|---|---|---|
| SAX catheter insertion | Active comparator | Procedure: SAX catheter insertionUltrasound guided cather insertion in the short axis (SAX) of the adductor canal. Injection of lidocaine through the catheter |
| LAX catheter insertion | Active comparator | Procedure: LAX catheter insertionUltrasound guided cather insertion in the long axis (LAX) of the adductor canal. Injection of lidocaine through the catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥18 years of age.
- ASA classification ≤ II.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria (3 listed)
- Previous surgery or ongoing pain or other disability of investigated region resulting in sensory or neurologic deficits in the investigated region.
- Allergy to LA.
- Pregnancy (all female participants will be tested for urine hCG), breastfeeding, or unwilling to practice birth control during participation in the study.
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 |
|---|---|---|
| SAX catheter insertionSuture-method catheter inserted in the short axis of the adductor canal | Procedure or surgery | SAX catheter insertion |
| LAX catheter insertionSuture-method catheter inserted in the long axis of the adductor canal | Procedure or surgery | LAX catheter insertion |
Primary outcome
Successful repositioning
Time frame: 15 min after second injection
Defined as a combination of spread within the adductor canal and loss of cold sensation on the medial part of the lower leg after repositioning and second LA injection. - investigator 3 will evaluate spread and investigator 2 will evaluate cold sensation
3 secondary outcomes
Successful primary placement
Time frame: 15 min after first injection
Estimation of Limits of Agreement
Time frame: within 15 minutes, after displacement/repositioning.(recorded by after displacement and repeated just before attempted repositioning)
Interrater agreement for satisfactory spread within the adductor Canal, (Cohen's Kappa)
Time frame: recorded immediately after second LA 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 20 Oct 2017.
- Derived from this study: PubMed 30355334Jordahn ZM, Lyngeraa TS, Grevstad U, Rothe C, Lundstrom LH, Lange KHW. Ultrasound guided repositioning of a new suture-method catheter for adductor canal block - a randomized pilot study in healthy volunteers. BMC Anesthesiol. 2018 Oct 24;18(1):150. doi: 10.1186/s12871-018-0615-4.
- 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.
Tobias S Lyngeraa, MD principal investigator
Research Unit, Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital Hilleroed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAX catheter insertion and LAX catheter insertion in people with Anesthesia and Pain, Postoperative, run by Nordsjaellands Hospital 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 3 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 20 Oct 2017. 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?
Successful repositioning (time frame: 15 min after second injection). 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 NCT03315481, 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 20 Oct 2017.