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

The Impact of Single-shot Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement (AdORe - ACB)

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.

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee; Gonarthrosis
• Intervention / Treatment: Procedure: Continuous femoral nerve block; Procedure: Single-shot adductor canal block

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valery Likhvantsev; Phone Number: +79036235982; Email: lik0704@gmail.com
• Study Contact Backup: Name: Levan Berikashvili; Phone Number: +79263308968; Email: levan.berikashvili@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 111033
    • Recruiting
    • Clinical Hospital on Yauza
    • Contact: Levan Berikashvili, PhD; Phone Number: +79263308968; Email: lb.berikashvili@gmail.com
    • Principal Investigator: Levan Berikashvili, PhD
    • Sub-Investigator: Sergey Stepanenko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-shot adductor canal block	Procedure: Single-shot adductor canal block; Postoperative analgesia in this group will be carried out by a single-shot bolus of 20 ml Ropivacaine 0.5% in the region of the middle third of the adductor canal.
Active Comparator: Continuous femoral nerve block	Procedure: Continuous femoral nerve block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulation distance	Less meters means worse outcome	postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulation distance	Less meters means worse outcome	postoperative day 2
Timed up and go test	More seconds means worse outcome	postoperative day 1
Timed up and go test	More seconds means worse outcome	postoperative day 2
10 meters walk test	More seconds means worse outcome	postoperative day 1
10 meters walk test	More seconds means worse outcome	postoperative day 2
30 seconds chair stand test	Less exercise done means worse outcome	postoperative day 1
30 seconds chair stand test	Less exercise done means worse outcome	postoperative day 2
5 times sit to stand test	More seconds means worse outcome	postoperative day 1
5 times sit to stand test	More seconds means worse outcome	postoperative day 2
time to readiness to dicharge	time from the day of surgery to the day of readiness to discharge	30 day
length of hospitalization	time from the day of surgery to the day of discharge	30 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intravascular local anesthetic injection	frequency of intravascular local anesthetic injection	30 day
neuropathy after the procedure	frequency of neuropathy after the procedure	30 day

Collaborators and Investigators

• Sponsor: Negovsky Reanimatology Research Institute
• Investigators: Principal Investigator: Valery Likhvantsev, Negovsky Reanimatology Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Analgesia; Total knee replacement; Osteo Arthritis Knee; Gonarthrosis; Postoperative analgesia; Regional anesthesia; Adductor canal block; Femoral nerve block; Continuous femoral nerve block; Continuous adductor canal block
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: AdORe - ACB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No