The Appropriate Level of Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty (TKA)

NCT04206150 | Completed DMC

• 1 other identifier: 4-2019-1038
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Adductor canal catheters are being used to provide continuous postoperative analgesia after total knee arthroplasty surgery (TKA). There is much debate about where is the best position of continuous adductor canal block in patients undergoing TKA. Therefore, the investigators aim to compare the postoperative pain at three different level of continuous adductor canal block. Ninety six patients scheduled for total knee arthroplasty will be randomly divided into the three groups. In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). In group 2, the adductor canal catheter is inserted femur length/15\*2 cm above the location where the nerve block performed in group 1. In group 3, the adductor canal catheter is inserted femur length/15cm below the location where the nerve block performed in group 1.

Conditions

Degenerative Arthritis

Outcome Measures

Primary Outcomes (3)

• Pain : Visual Analogue Scale (VAS) for pain

  The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).

  Baseline (Before surgery)

• Pain : Visual Analogue Scale (VAS) for pain

  The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).

  postoperative day 1

• Pain : Visual Analogue Scale (VAS) for pain

  The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).

  postoperative day 2

Secondary Outcomes (3)

• muscle strength

  Baseline (Before surgery)

• muscle strength

  postoperative day 1

• muscle strength

  postoperative day 2

Study Arms (3)

Group 1(femoral triangle apex)

ACTIVE COMPARATOR

the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal)

Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex

Group 2(femur length/15*2 cm above)

ACTIVE COMPARATOR

the adductor canal catheter is inserted femur length/15\*2 cm above the location where the nerve block performed in group 1

Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location

Group 3(femur length/15 cm below)

ACTIVE COMPARATOR

the adductor canal catheter is inserted femur length/15cm below the location where the nerve block performed in group 1.

Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location

Interventions

the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex PROCEDURE

In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal).

Group 1(femoral triangle apex)

the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location PROCEDURE

In group 2, the adductor canal catheter is inserted femur length/15\*2 cm above the location where the nerve block performed in group 1.

Group 2(femur length/15*2 cm above)

the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location PROCEDURE

In group 3, the adductor canal catheter is inserted femur length/15 cm below the location where the nerve block performed in group 1.

Group 3(femur length/15 cm below)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients undergoing total knee arthroplasty

You may not qualify if:

• \. Patients who have infection or had surgery on the thigh
• \. The subject is a foreigner or illiterate
• \. Patients who have cognitive dysfunction

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (3)

• Chuan A, Lansdown A, Brick KL, Bourgeois AJG, Pencheva LB, Hue B, Goddard S, Lennon MJ, Walters A, Auyong D; Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE study) investigators. Adductor canal versus femoral triangle anatomical locations for continuous catheter analgesia after total knee arthroplasty: a multicentre randomised controlled study. Br J Anaesth. 2019 Sep;123(3):360-367. doi: 10.1016/j.bja.2019.03.021. Epub 2019 May 2.

  PMID: 31056239 BACKGROUND

• Sztain JF, Khatibi B, Monahan AM, Said ET, Abramson WB, Gabriel RA, Finneran JJ 4th, Bellars RH, Nguyen PL, Ball ST, Gonzales FB, Ahmed SS, Donohue MC, Padwal JA, Ilfeld BM. Proximal Versus Distal Continuous Adductor Canal Blocks: Does Varying Perineural Catheter Location Influence Analgesia? A Randomized, Subject-Masked, Controlled Clinical Trial. Anesth Analg. 2018 Jul;127(1):240-246. doi: 10.1213/ANE.0000000000003422.

  PMID: 29750695 BACKGROUND

• Lee B, Park SJ, Park KK, Kim HJ, Lee YS, Choi YS. Optimal location for continuous catheter analgesia among the femoral triangle, proximal, or distal adductor canal after total knee arthroplasty: a randomized double-blind controlled trial. Reg Anesth Pain Med. 2022 Jun;47(6):353-358. doi: 10.1136/rapm-2021-103284. Epub 2022 Feb 16.

  PMID: 35173020 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor are blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ninety six patients scheduled for total knee arthroplasty will be randomly divided into the three groups. In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). In group 2, the adductor canal catheter is inserted femur length/15\*2 cm above the location where the nerve block performed in group 1. In group 3, the adductor canal catheter is inserted femur length/15\*2 cm below the location where the nerve block performed in group 1.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 20, 2019
• Study Start: April 2, 2020
• Primary Completion: July 16, 2021
• Study Completion: July 17, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)