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Continuous Adductor Canal Block With a New Catheter - Primary Placement and Secondary Repositioning

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ClinicalTrials.gov Identifier: NCT02657603
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark

Brief 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. 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

Condition or disease Intervention/treatment Phase
Pain Drug: Lidocaine Procedure: LAX insertion of catheter Procedure: SAX insertion of catheter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Continuous Adductor Canal Block With a New Catheter - Primary Placement and Secondary Repositioning
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: LAX insertion of catheter
Lidocaine 10mg/ml, 15 ml injected into the adductor canal
Drug: Lidocaine
Lidocaine injected through the new Catheter (LAX)
Other Names:
  • Lidocainehydrochlorid
  • Xylocaine

Procedure: LAX insertion of catheter
ultra sound guided cather insertion in the long axis (LAX) of the adductor canal

Active Comparator: SAX insertion of catheter
Lidocaine 10mg/ml, 15 ml injected into the contralateral adductor canal
Drug: Lidocaine
Lidocaine injected through the new Catheter (SAX)
Other Names:
  • Lidocainehydrochlorid
  • Xylocaine

Procedure: SAX insertion of catheter
ultra sound guided cather insertion in the short axis (SAX) of the adductor canal




Primary Outcome Measures :
  1. Loss of cold sensation [ Time Frame: 30 minutes after injection ]
    Loss of cold sensation after injection of Lidocaine(LA)


Secondary Outcome Measures :
  1. Discomfort during day 1 [ Time Frame: 1 day ]
    Rating on a scale from 1-10 overall, at rest and during activities and disturbance of sleep

  2. Loss of cold sensation on day 2 - indicating correct position of the catheter on day 2 [ Time Frame: 1 day after insertion ]
    loss of cold sensation on the medial part of the lower leg after LA injection on day 2

  3. Interrater agreement between 2 assessors whether catheter is within the adductor canal assessed by US video. [ Time Frame: 1 day ]
    cohen's kappa for interrater agreement between assessments

  4. Displacement distance [ Time Frame: 1 day ]
    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

  5. Loss of cold sensation after repositioning if found to be displaced - Indicating successful repositioning [ Time Frame: 1 day ]
    loss of cold sensation on the medial part of the lower leg after LA injection after attempted repositioning


Other Outcome Measures:
  1. Procedure time [ Time Frame: 1 hour ]
    time used from penetration of skin to needle exit.

  2. insertion attempts [ Time Frame: 1 hour ]
    number of skin punctures for insertion

  3. Affected skin area [ Time Frame: 1 hour ]
    cutaneous mapping of the skin area on the medial part of the lower with loss of cold sensation evaluated by application of an ice roller and outlining with a marker (pen) for comparison



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657603


Locations
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Denmark
Nordsjællands Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Kai Henrik Wiborg Lange
Investigators
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Principal Investigator: Tobias S Lyngeraa, MD Nordsjællands Hospital

Additional Information:
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Responsible Party: Kai Henrik Wiborg Lange, Head Of Research, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT02657603     History of Changes
Other Study ID Numbers: H-15016829
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark:
Peripheral Nerve Blocks

Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action