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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487053
• Other study ID #: AdORe - ACB
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: Negovsky Reanimatology Research Institute
• Contact: Valery Likhvantsev
• Phone: +79036235982
• Email: lik0704[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Gonarthrosis
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Clinical Hospital on Yauza	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Negovsky Reanimatology Research Institute

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intravascular local anesthetic injection	frequency of intravascular local anesthetic injection	30 day
Other	neuropathy after the procedure	frequency of neuropathy after the procedure	30 day
Primary	Ambulation distance	Less meters means worse outcome	postoperative day 1
Secondary	Ambulation distance	Less meters means worse outcome	postoperative day 2
Secondary	Timed up and go test	More seconds means worse outcome	postoperative day 1
Secondary	Timed up and go test	More seconds means worse outcome	postoperative day 2
Secondary	10 meters walk test	More seconds means worse outcome	postoperative day 1
Secondary	10 meters walk test	More seconds means worse outcome	postoperative day 2
Secondary	30 seconds chair stand test	Less exercise done means worse outcome	postoperative day 1
Secondary	30 seconds chair stand test	Less exercise done means worse outcome	postoperative day 2
Secondary	5 times sit to stand test	More seconds means worse outcome	postoperative day 1
Secondary	5 times sit to stand test	More seconds means worse outcome	postoperative day 2
Secondary	time to readiness to dicharge	time from the day of surgery to the day of readiness to discharge	30 day
Secondary	length of hospitalization	time from the day of surgery to the day of discharge	30 day