Continuous Adductor Canal Block With a New Catheter - Primary Placement and Secondary Repositioning
|ClinicalTrials.gov Identifier: NCT02657603|
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Lidocaine Procedure: LAX insertion of catheter Procedure: SAX insertion of catheter||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Active Comparator: LAX insertion of catheter
Lidocaine 10mg/ml, 15 ml injected into the adductor canal
Lidocaine injected through the new Catheter (LAX)
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
Lidocaine injected through the new Catheter (SAX)
Procedure: SAX insertion of catheter
ultra sound guided cather insertion in the short axis (SAX) of the adductor canal
- Loss of cold sensation [ Time Frame: 30 minutes after injection ]Loss of cold sensation after injection of Lidocaine(LA)
- 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
- 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
- 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
- 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
- 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
- Procedure time [ Time Frame: 1 hour ]time used from penetration of skin to needle exit.
- insertion attempts [ Time Frame: 1 hour ]number of skin punctures for insertion
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657603
|Hillerød, Denmark, 3400|
|Principal Investigator:||Tobias S Lyngeraa, MD||Nordsjællands Hospital|