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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Arthritis
• Intervention / Treatment: Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex; Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location; Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Patients undergoing total knee arthroplasty

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1(femoral triangle apex); 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; In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal).
ACTIVE_COMPARATOR: Group 2(femur length/15*2 cm above); 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; 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.
ACTIVE_COMPARATOR: Group 3(femur length/15 cm below); 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; In group 3, the adductor canal catheter is inserted femur length/15 cm below the location where the nerve block performed in group 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength	Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.	Baseline (Before surgery)
muscle strength	Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.	postoperative day 1
muscle strength	Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.	postoperative day 2

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2020
• Primary Completion (ACTUAL): July 16, 2021
• Study Completion (ACTUAL): July 17, 2021

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (ACTUAL): December 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 4-2019-1038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No