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
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
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
NCT ID
NCT05487053
First Posted
August 3, 2022
Last Updated
December 15, 2022
Sponsor
Negovsky Reanimatology Research Institute
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
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