PainNCT02657603
Continuous Adductor Canal Block With a New Catheter - Primary Placement and Secondary Repositioning
A study testing Lidocaine, LAX insertion of catheter and SAX insertion of catheter in people with Pain, run by Kai Henrik Wiborg Lange at 1 site in Denmark.
Trial summary
This is a single center, randomized, blinded trial in healthy volunteers. The volunteers will receive bilateral placement of the new catheter corresponding to the adductor canal. Each volunteer will have a catheter placed in the adductor canal in both legs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine, LAX insertion of catheter and SAX insertion of catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Mar 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
- Male or female ≥18 years of age.
- ASA classification ≤ II. (ASA physical status classification system)
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Distance from skin to adductor canal above 4 cm
- Previous or ongoing surgery, pain or other disability of the 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
This is a single center, randomized, blinded trial in healthy volunteers. The volunteers will receive bilateral placement of the new catheter corresponding to the adductor canal. Each volunteer will have a catheter placed in the adductor canal in both legs. The catheters are randomized to be placed either in the long-axis or short-axis plane of the adductor canal. Both catheters will be injected with local analgesics (LA). Allocation will be blinded to the volunteer and the investigator assessing sensory function. The volunteers will be sent home with the catheter in situ and return the following day. Injection with LA is repeated and sensory function is tested again. Furthermore catheter position is determined with ultrasound during injection. If sensory function is not affected by injection of LA then the catheter is visualized with ultrasound and repositioned followed by a second injection of LA and subsequent assessment of sensory function
Read the detailed description
3.2.1 Allocation concealment The volunteers are randomized using sealed opaque envelopes with a 1:1 ratio. The randomization defines which leg will be used for insertion of a catheter in the long-axis plane and which leg will be used for insertion in the short-axis plane of the adductor canal. The envelopes are prepared by health personnel with no relation to the study based on a computer-generated list.
3.2.2 Blinding Volunteers will be blinded to allocation. An opaque sterile draping will be used for insertion to prevent volunteers from observing the catheter insertion. After insertion the catheters will be covered with bandages to prevent unblinding of the volunteers. The investigator responsible for insertion of the catheters will leave the room after insertion and a separate assessor blinded to allocation will perform outcome assessments. On day 2 the investigator responsible for primary insertion will assess catheter position with ultra-sound (US), record a video for the assessors, injection of local anesthetics and cover the catheter in bandages. A separate blinded assessor will again perform the outcome assessment
3.2.3 Execution During catheter placement the volunteers are monitored using pulse oximetry and a secure intravenous access is obtained. A baseline sensory assessment is performed where cold sensation on the medial side of the lower leg is tested using alcohol swabs.
A peripheral nerve catheter will be inserted on each side under US guidance. This involves skin punctures at the site of insertion and at the exit site. To facilitate insertion the skin is locally infiltrated with lidocaine. Intravenous analgesia is provided if necessary (alfentanil 0.5mg/ml).
One catheter is inserted in the short-axis plane of the adductor canal using an in plane technique. The second catheter is inserted in the long-axis plane using a dynamic combination of in plane and out of plane techniques. 10ml of normal saline is used for hydro dissection in both catheters. When the catheters are in place 15 mL of LA (lidocaine 10mg/ml) is injected in each catheter. Distance from catheter orifice to artery is noted in the short axis group and distance from catheter orifice to fascia penetration is noted in the long axis group. After injection, the catheters are fixated to the skin with dressings.
Successful primary placement of the catheters will be tested 30 minutes after injection by a blinded investigator using a bilateral assessment of sensory function as described previously. Furthermore, cutaneous mapping is performed to assess affected cutaneous area.
Subsequently the volunteers are sent home with the catheter in situ and return the following day. The volunteers are instructed not to exercise -i.e. running, cycling, weight training etc.
On day 2 the catheter position is assessed with US during injection of LA and the distance from catheter orifice to artery/fascia is determined. A sensory assessment is performed. If there is no loss of cold sensation the catheter is registered as displaced and is therefore manually repositioned and injected with LA using US guidance. Assessment of cold sensation is repeated. Further, two investigators will independently watch a video clip of the injection procedure to assess whether the position is within the adductor canal. Total duration of participation for the individual volunteers will be 2 days.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Lidocainehydrochlorid, Xylocaine
Lidocaine injected through the new Catheter (LAX)
LidocaineDrug
Also called Lidocainehydrochlorid, Xylocaine
Lidocaine injected through the new Catheter (SAX)
LAX insertion of catheterProcedure or surgery
ultra sound guided cather insertion in the long axis (LAX) of the adductor canal
SAX insertion of catheterProcedure or surgery
ultra sound guided cather insertion in the short axis (SAX) of the adductor canal
| Study group | Role | What they receive |
|---|---|---|
| LAX insertion of catheter | Active comparator | Lidocaine 10mg/ml, 15 ml injected into the adductor canal Receives: Drug: Lidocaine; Procedure: LAX insertion of catheter |
| SAX insertion of catheter | Active comparator | Lidocaine 10mg/ml, 15 ml injected into the contralateral adductor canal Receives: Drug: Lidocaine; Procedure: SAX insertion of catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of cold sensation
Loss of cold sensation after injection of Lidocaine(LA)
Measured: 30 minutes after injection
Secondary outcomes (5)
Discomfort during day 1
Rating on a scale from 1-10 overall, at rest and during activities and disturbance of sleep
Measured: 1 day
Loss of cold sensation on day 2 - indicating correct position of the catheter on day 2
loss of cold sensation on the medial part of the lower leg after LA injection on day 2
Measured: 1 day after insertion
Interrater agreement between 2 assessors whether catheter is within the adductor canal assessed by US video.
cohen's kappa for interrater agreement between assessments
Measured: 1 day
Displacement distance
Distance from catheter orifice to artery is noted in the short axis group and distance from catheter orifice to fascia penetration is noted in the long axis group
Measured: 1 day
Loss of cold sensation after repositioning if found to be displaced - Indicating successful repositioning
loss of cold sensation on the medial part of the lower leg after LA injection after attempted repositioning
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kai Henrik Wiborg Lange
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark
- Investigators
- Tobias S Lyngeraa, MD, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657603
- Sponsor's protocol ID
- H-15016829
- Status last verified
- Oct 2017
- First submitted
- 11 Jan 2016
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Adductor Canal Block With a New Catheter - Primary Placement and Secondary Repositioning
- ClinicalTrials.gov ID
- NCT02657603
- Acronym / sponsor ID
- H-15016829
- Conditions
- Pain
- Keywords
- Peripheral Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kai Henrik Wiborg LangeUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Jan 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.
This is a single center, randomized, blinded trial in healthy volunteers. The volunteers will receive bilateral placement of the new catheter corresponding to the adductor canal. Each volunteer will have a catheter placed in the adductor canal in both legs. The catheters are randomized to be placed either in the long-axis or short-axis plane of the adductor canal. Both catheters will be injected with local analgesics (LA). Allocation will be blinded to the volunteer and the investigator assessing sensory function. The volunteers will be sent home with the catheter in situ and return the following day. Injection with LA is repeated and sensory function is tested again. Furthermore catheter position is determined with ultrasound during injection. If sensory function is not affected by injection of LA then the catheter is visualized with ultrasound and repositioned followed by a second injection of LA and subsequent assessment of sensory function
Detailed description
3.2.1 Allocation concealment The volunteers are randomized using sealed opaque envelopes with a 1:1 ratio. The randomization defines which leg will be used for insertion of a catheter in the long-axis plane and which leg will be used for insertion in the short-axis plane of the adductor canal. The envelopes are prepared by health personnel with no relation to the study based on a computer-generated list.
3.2.2 Blinding Volunteers will be blinded to allocation. An opaque sterile draping will be used for insertion to prevent volunteers from observing the catheter insertion. After insertion the catheters will be covered with bandages to prevent unblinding of the volunteers. The investigator responsible for insertion of the catheters will leave the room after insertion and a separate assessor blinded to allocation will perform outcome assessments. On day 2 the investigator responsible for primary insertion will assess catheter position with ultra-sound (US), record a video for the assessors, injection of local anesthetics and cover the catheter in bandages. A separate blinded assessor will again perform the outcome assessment
3.2.3 Execution During catheter placement the volunteers are monitored using pulse oximetry and a secure intravenous access is obtained. A baseline sensory assessment is performed where cold sensation on the medial side of the lower leg is tested using alcohol swabs.
A peripheral nerve catheter will be inserted on each side under US guidance. This involves skin punctures at the site of insertion and at the exit site. To facilitate insertion the skin is locally infiltrated with lidocaine. Intravenous analgesia is provided if necessary (alfentanil 0.5mg/ml).
One catheter is inserted in the short-axis plane of the adductor canal using an in plane technique. The second catheter is inserted in the long-axis plane using a dynamic combination of in plane and out of plane techniques. 10ml of normal saline is used for hydro dissection in both catheters. When the catheters are in place 15 mL of LA (lidocaine 10mg/ml) is injected in each catheter. Distance from catheter orifice to artery is noted in the short axis group and distance from catheter orifice to fascia penetration is noted in the long axis group. After injection, the catheters are fixated to the skin with dressings.
Successful primary placement of the catheters will be tested 30 minutes after injection by a blinded investigator using a bilateral assessment of sensory function as described previously. Furthermore, cutaneous mapping is performed to assess affected cutaneous area.
Subsequently the volunteers are sent home with the catheter in situ and return the following day. The volunteers are instructed not to exercise -i.e. running, cycling, weight training etc.
On day 2 the catheter position is assessed with US during injection of LA and the distance from catheter orifice to artery/fascia is determined. A sensory assessment is performed. If there is no loss of cold sensation the catheter is registered as displaced and is therefore manually repositioned and injected with LA using US guidance. Assessment of cold sensation is repeated. Further, two investigators will independently watch a video clip of the injection procedure to assess whether the position is within the adductor canal. Total duration of participation for the individual volunteers will be 2 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAX insertion of catheter | Active comparator | Drug: Lidocaine, Procedure: LAX insertion of catheterLidocaine 10mg/ml, 15 ml injected into the adductor canal |
| SAX insertion of catheter | Active comparator | Drug: Lidocaine, Procedure: SAX insertion of catheterLidocaine 10mg/ml, 15 ml injected into the contralateral adductor canal |
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. (ASA physical status classification system)
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria (4 listed)
- Distance from skin to adductor canal above 4 cm
- Previous or ongoing surgery, pain or other disability of the 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 |
|---|---|---|
| LidocaineAlso: Lidocainehydrochlorid, XylocaineLidocaine injected through the new Catheter (LAX) | Drug | LAX insertion of catheter |
| LidocaineAlso: Lidocainehydrochlorid, XylocaineLidocaine injected through the new Catheter (SAX) | Drug | SAX insertion of catheter |
| LAX insertion of catheterultra sound guided cather insertion in the long axis (LAX) of the adductor canal | Procedure or surgery | LAX insertion of catheter |
| SAX insertion of catheterultra sound guided cather insertion in the short axis (SAX) of the adductor canal | Procedure or surgery | SAX insertion of catheter |
Primary outcome
Loss of cold sensation
Time frame: 30 minutes after injection
Loss of cold sensation after injection of Lidocaine(LA)
5 secondary outcomes
Discomfort during day 1
Time frame: 1 day
Loss of cold sensation on day 2 - indicating correct position of the catheter on day 2
Time frame: 1 day after insertion
Interrater agreement between 2 assessors whether catheter is within the adductor canal assessed by US video.
Time frame: 1 day
Displacement distance
Time frame: 1 day
Loss of cold sensation after repositioning if found to be displaced - Indicating successful repositioning
Time frame: 1 day
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 19 Oct 2017.
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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
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, LAX insertion of catheter and SAX insertion of catheter in people with Pain, run by Kai Henrik Wiborg Lange 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 4 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 19 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?
Loss of cold sensation (time frame: 30 minutes after 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 19 Oct 2017.