search
Back to results

The Impact of Continuous Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement

Primary Purpose

Osteo Arthritis Knee, Gonarthrosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous adductor canal block
Continuous femoral nerve block
Sponsored by
Negovsky Reanimatology Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Osteo Arthritis Knee, Gonarthrosis, Regional anesthesia, Analgesia, Postoperative analgesia, Total knee replacement, Continuous femoral nerve block, Femoral nerve block, Continuous adductor canal block, Adductor canal block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18
  • Planned primary total knee replacement
  • Planned neuraxial anesthesia
  • Written informed consent

Exclusion Criteria:

  • Urgent surgery
  • Planned revision total knee replacement
  • Known allergic reaction to anesthetics
  • Confirmed localized infection at the puncture sites
  • Confirmed localized tumor at the puncture sites
  • Peripheral neuropathy of the lower extremities
  • Parkinson's disease
  • Previously enrolled in this trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Continuous adductor canal block

    Continuous femoral nerve block

    Arm Description

    Outcomes

    Primary Outcome Measures

    Ambulation distance
    Less meters means worse outcome

    Secondary Outcome Measures

    Ambulation distance
    Less meters means worse outcome
    Timed up and go test
    More seconds means worse outcome
    Timed up and go test
    More seconds means worse outcome
    10 meters walk test
    More seconds means worse outcome
    10 meters walk test
    More seconds means worse outcome
    30 seconds chair stand test
    Less exercise done means worse outcome
    30 seconds chair stand test
    Less exercise done means worse outcome
    5 times sit to stand test
    More seconds means worse outcome
    5 times sit to stand test
    More seconds means worse outcome
    time to readiness to dicharge
    time from the day of surgery to the day of readiness to discharge
    length of hospitalization
    time from the day of surgery to the day of discharge

    Full Information

    First Posted
    August 3, 2022
    Last Updated
    December 15, 2022
    Sponsor
    Negovsky Reanimatology Research Institute
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05487053
    Brief Title
    The Impact of Continuous Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement
    Official Title
    The Impact of Continuous Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement (AdORe - ACB)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Negovsky Reanimatology Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Total knee replacement (TKR) is considered the most effective and safe method of radical treatment of late stages of knee osteoarthritis. A well-known problem of TKR is a severe postoperative pain syndrome, which is observed in more than 50% of patients. Femoral nerve block (FNB) is the "gold standard" for continuous postoperative analgesia after total knee replacement, as it is effective in reducing the frequency of use of opioid analgetics and reduce the duration of hospitalization. At the same time, the negative effect of this method is the motor blockade of the quadriceps femoris muscle which leads to functional impairment and is associated with an increased risk of falling. Adductor canal block (ACB) provides adequate analgesia comparable to femoral nerve block. Moreover, ACB doesn't affect the motor function of the quadriceps femoris muscle. The possibility of enhanced recovery after total knee replacement is the reason to compare continuous adductor canal block and continuous femoral nerve block.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Knee, Gonarthrosis
    Keywords
    Osteo Arthritis Knee, Gonarthrosis, Regional anesthesia, Analgesia, Postoperative analgesia, Total knee replacement, Continuous femoral nerve block, Femoral nerve block, Continuous adductor canal block, Adductor canal block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    440 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous adductor canal block
    Arm Type
    Experimental
    Arm Title
    Continuous femoral nerve block
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Continuous adductor canal block
    Intervention Description
    Postoperative analgesia in this group will be carried out by continuous infusion of local anesthetics through a catheter installed in the region of the middle third of the adductor canal. Ropivacaine 0.2% solution will be used for postoperative analgesia. Local anesthetic infusion rate is 4 ml/h to 10 ml/h.
    Intervention Type
    Procedure
    Intervention Name(s)
    Continuous femoral nerve block
    Intervention Description
    Postoperative analgesia in this group will be carried out by continuous infusion of local anesthetics through a catheter installed to the femoral nerve in the area of the femoral triangle. Ropivacaine 0.2% solution will be used for postoperative analgesia. Local anesthetic infusion rate is 4 ml/h to 10 ml/h.
    Primary Outcome Measure Information:
    Title
    Ambulation distance
    Description
    Less meters means worse outcome
    Time Frame
    postoperative day 1
    Secondary Outcome Measure Information:
    Title
    Ambulation distance
    Description
    Less meters means worse outcome
    Time Frame
    postoperative day 2
    Title
    Timed up and go test
    Description
    More seconds means worse outcome
    Time Frame
    postoperative day 1
    Title
    Timed up and go test
    Description
    More seconds means worse outcome
    Time Frame
    postoperative day 2
    Title
    10 meters walk test
    Description
    More seconds means worse outcome
    Time Frame
    postoperative day 1
    Title
    10 meters walk test
    Description
    More seconds means worse outcome
    Time Frame
    postoperative day 2
    Title
    30 seconds chair stand test
    Description
    Less exercise done means worse outcome
    Time Frame
    postoperative day 1
    Title
    30 seconds chair stand test
    Description
    Less exercise done means worse outcome
    Time Frame
    postoperative day 2
    Title
    5 times sit to stand test
    Description
    More seconds means worse outcome
    Time Frame
    postoperative day 1
    Title
    5 times sit to stand test
    Description
    More seconds means worse outcome
    Time Frame
    postoperative day 2
    Title
    time to readiness to dicharge
    Description
    time from the day of surgery to the day of readiness to discharge
    Time Frame
    30 day
    Title
    length of hospitalization
    Description
    time from the day of surgery to the day of discharge
    Time Frame
    30 day
    Other Pre-specified Outcome Measures:
    Title
    intravascular local anesthetic injection
    Description
    frequency of intravascular local anesthetic injection
    Time Frame
    30 day
    Title
    neuropathy after the procedure
    Description
    frequency of neuropathy after the procedure
    Time Frame
    30 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 Planned primary total knee replacement Planned neuraxial anesthesia Written informed consent Exclusion Criteria: Urgent surgery Planned revision total knee replacement Known allergic reaction to anesthetics Confirmed localized infection at the puncture sites Confirmed localized tumor at the puncture sites Peripheral neuropathy of the lower extremities Parkinson's disease Previously enrolled in this trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Valery Likhvantsev
    Phone
    +79036235982
    Email
    lik0704@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Levan Berikashvili
    Phone
    +79263308968
    Email
    levan.berikashvili@mail.ru
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Valery Likhvantsev
    Organizational Affiliation
    Negovsky Reanimatology Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Impact of Continuous Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement

    We'll reach out to this number within 24 hrs