Clinical trial NCT05487053: The Impact of Single-shot Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement
Official title: The Impact of Single-shot Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement (AdORe - ACB)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Negovsky Reanimatology Research Institute
Sponsor class: OTHER_GOV
First posted: 2022-08-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 single-shot adductor canal block and continuous femoral nerve 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

Primary outcomes:
measure: Ambulation distance
timeFrame: postoperative day 1
Secondary outcomes:
measure: Ambulation distance
timeFrame: postoperative day 2
measure: Timed up and go test
timeFrame: postoperative day 1
measure: Timed up and go test
timeFrame: postoperative day 2
measure: 10 meters walk test
timeFrame: postoperative day 1
measure: 10 meters walk test
timeFrame: postoperative day 2
measure: 30 seconds chair stand test
timeFrame: postoperative day 1
measure: 30 seconds chair stand test
timeFrame: postoperative day 2
measure: 5 times sit to stand test
timeFrame: postoperative day 1
measure: 5 times sit to stand test
timeFrame: postoperative day 2
measure: time to readiness to dicharge
timeFrame: 30 day
measure: length of hospitalization
timeFrame: 30 day
Other outcomes:
measure: intravascular local anesthetic injection
timeFrame: 30 day
measure: neuropathy after the procedure
timeFrame: 30 day
Locations:
city: Moscow
country: Russian Federation
facility: Clinical Hospital on Yauza
Study officials:
affiliation: Negovsky Reanimatology Research Institute
name: Valery Likhvantsev
role: PRINCIPAL_INVESTIGATOR
References: