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

NCT03315481 | Completed

• 1 other identifier: H-16029530
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Pain, Postoperative; Pain; Pain, Joint

Outcome Measures

Primary Outcomes (1)

• 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

  15 min after second injection

Secondary Outcomes (3)

• Successful primary placement

  15 min after first injection

• Estimation of Limits of Agreement

  within 15 minutes, after displacement/repositioning.(recorded by after displacement and repeated just before attempted repositioning)

• Interrater agreement for satisfactory spread within the adductor Canal, (Cohen's Kappa)

  recorded immediately after second LA injection

Study Arms (2)

SAX catheter insertion

ACTIVE COMPARATOR

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

Procedure: SAX catheter insertion

LAX catheter insertion

ACTIVE COMPARATOR

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

Procedure: LAX catheter insertion

Interventions

SAX catheter insertion PROCEDURE

Suture-method catheter inserted in the short axis of the adductor canal

SAX catheter insertion

LAX catheter insertion PROCEDURE

Suture-method catheter inserted in the long axis of the adductor canal

LAX catheter insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30355334 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Arthralgia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Tobias S Lyngeraa, MD

  Research Unit, Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital Hilleroed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: October 20, 2017
• Study Start: March 7, 2017
• Primary Completion: April 18, 2017
• Study Completion: April 18, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)