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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206150
Recruitment Status : Completed
First Posted : December 20, 2019
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Degenerative Arthritis 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigator and outcomes assessor are blinded to group assignment.
Primary Purpose: Treatment
Official Title: The Appropriate Level of Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty (TKA)
Actual Study Start Date : April 2, 2020
Actual Primary Completion Date : July 16, 2021
Actual Study Completion Date : July 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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.




Primary Outcome Measures :
  1. Pain : Visual Analogue Scale (VAS) for pain [ Time Frame: Baseline (Before surgery) ]
    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).

  2. Pain : Visual Analogue Scale (VAS) for pain [ Time Frame: postoperative day 1 ]
    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).

  3. Pain : Visual Analogue Scale (VAS) for pain [ Time Frame: postoperative day 2 ]
    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).


Secondary Outcome Measures :
  1. muscle strength [ Time Frame: Baseline (Before surgery) ]
    Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.

  2. muscle strength [ Time Frame: postoperative day 1 ]
    Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.

  3. muscle strength [ Time Frame: postoperative day 2 ]
    Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206150


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04206150    
Other Study ID Numbers: 4-2019-1038
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases