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Ultrasound Guided Repositioning of a New Suture-Method Catheter for Adductor Canal Block

Primary Purpose

Anesthesia, Pain, Postoperative, Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
SAX catheter insertion
LAX catheter insertion
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Nordsjællands Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SAX catheter insertion

LAX catheter insertion

Arm Description

Ultrasound guided cather insertion in the short axis (SAX) of the adductor canal. Injection of lidocaine through the catheter

Ultrasound guided cather insertion in the long axis (LAX) of the adductor canal. Injection of lidocaine through the catheter

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Estimation of Limits of Agreement
in evaluation of displacement distance of the catheter between investigator 1 and 3
Interrater agreement for satisfactory spread within the adductor Canal, (Cohen's Kappa)
Investigator 3 and 4 will independently evaluate spread within the adductor canal.

Full Information

First Posted
March 1, 2017
Last Updated
October 16, 2017
Sponsor
Nordsjaellands Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03315481
Brief Title
Ultrasound Guided Repositioning of a New Suture-Method Catheter for Adductor Canal Block
Official Title
Ultrasound Guided Repositioning of a New Suture-method Catheter for Adductor Canal Block - a Randomized Study in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
April 18, 2017 (Actual)
Study Completion Date
April 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordsjaellands Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Pain, Postoperative, Pain, Pain, Joint

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
The volunteers are randomized using sealed opaque envelopes with a 1:1 ratio. The randomization defines which leg to be used for insertion of a catheter in the long-axis plane and which leg to be used for insertion in the short-axis plane of the adductor canal. Furthermore the randomization defines whether dislocation is executed in the direction of the entry or exit site. The envelopes are prepared by health personnel with no relation to the study and are based on a computer-generated randomization list. Investigator 2, evaluating loss of sensation to cold, will be blinded to insertion technique and direction of dislocation as well as assessments of spread within the adductor canal. Investigators 3+4 are blinded with regard to direction of dislocation, each other's assessment of spread and to assessments from investigator 1+2. They will be unblinded with regard to insertion technique when they perform US scans
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAX catheter insertion
Arm Type
Active Comparator
Arm Description
Ultrasound guided cather insertion in the short axis (SAX) of the adductor canal. Injection of lidocaine through the catheter
Arm Title
LAX catheter insertion
Arm Type
Active Comparator
Arm Description
Ultrasound guided cather insertion in the long axis (LAX) of the adductor canal. Injection of lidocaine through the catheter
Intervention Type
Procedure
Intervention Name(s)
SAX catheter insertion
Intervention Description
Suture-method catheter inserted in the short axis of the adductor canal
Intervention Type
Procedure
Intervention Name(s)
LAX catheter insertion
Intervention Description
Suture-method catheter inserted in the long axis of the adductor canal
Primary Outcome Measure Information:
Title
Successful repositioning
Description
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
Time Frame
15 min after second injection
Secondary Outcome Measure Information:
Title
Successful primary placement
Description
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
Time Frame
15 min after first injection
Title
Estimation of Limits of Agreement
Description
in evaluation of displacement distance of the catheter between investigator 1 and 3
Time Frame
within 15 minutes, after displacement/repositioning.(recorded by after displacement and repeated just before attempted repositioning)
Title
Interrater agreement for satisfactory spread within the adductor Canal, (Cohen's Kappa)
Description
Investigator 3 and 4 will independently evaluate spread within the adductor canal.
Time Frame
recorded immediately after second LA injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias S Lyngeraa, MD
Organizational Affiliation
Research Unit, Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital Hilleroed
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30355334
Citation
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.
Results Reference
derived

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Ultrasound Guided Repositioning of a New Suture-Method Catheter for Adductor Canal Block

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