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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT04206150
Collaborator
(none)
96
1
3
15.5
6.2

Study Details

Study Description

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
  • 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
N/A

Study Design

Study Type:
Interventional
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.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/152 cm above the location where the nerve block performed in group 1. In group 3, the adductor canal catheter is inserted femur length/152 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 :
Apr 2, 2020
Actual Primary Completion Date :
Jul 16, 2021
Actual Study Completion Date :
Jul 17, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

    Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Patients undergoing total knee arthroplasty
Exclusion Criteria:
    1. Patients who have infection or had surgery on the thigh
    1. The subject is a foreigner or illiterate
    1. Patients who have cognitive dysfunction

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT04206150
Other Study ID Numbers:
  • 4-2019-1038
First Posted:
Dec 20, 2019
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021