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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04206150
Other study ID # 4-2019-1038
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2, 2020
Est. completion date July 17, 2021

Study information

Verified date October 2021
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date July 17, 2021
Est. primary completion date July 16, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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.
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.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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
Primary 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 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)
Secondary 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
Secondary 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
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