Continuous Adductor Canal Block With a New Catheter - Primary Placement and Secondary Repositioning
NCT ID: NCT02657603
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
16 participants
INTERVENTIONAL
2016-01-31
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LAX insertion of catheter
Lidocaine 10mg/ml, 15 ml injected into the adductor canal
Lidocaine
Lidocaine injected through the new Catheter (LAX)
LAX insertion of catheter
ultra sound guided cather insertion in the long axis (LAX) of the adductor canal
SAX insertion of catheter
Lidocaine 10mg/ml, 15 ml injected into the contralateral adductor canal
Lidocaine
Lidocaine injected through the new Catheter (SAX)
SAX insertion of catheter
ultra sound guided cather insertion in the short axis (SAX) of the adductor canal
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lidocaine
Lidocaine injected through the new Catheter (LAX)
Lidocaine
Lidocaine injected through the new Catheter (SAX)
LAX insertion of catheter
ultra sound guided cather insertion in the long axis (LAX) of the adductor canal
SAX insertion of catheter
ultra sound guided cather insertion in the short axis (SAX) of the adductor canal
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kai Henrik Wiborg Lange
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kai Henrik Wiborg Lange
Head Of Research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tobias S Lyngeraa, MD
Role: PRINCIPAL_INVESTIGATOR
Nordsjaellands Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nordsjællands Hospital
Hillerød, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-15016829
Identifier Type: -
Identifier Source: org_study_id