NCT05487053

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Feb 2024Jul 2028

First Submitted

Initial submission to the registry

August 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 3, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

August 3, 2022

Last Update Submit

April 10, 2026

Conditions

Osteo Arthritis KneeGonarthrosis

Keywords

Osteo Arthritis KneeGonarthrosisRegional anesthesiaAnalgesiaPostoperative analgesiaTotal knee replacementContinuous femoral nerve blockFemoral nerve blockContinuous adductor canal blockAdductor canal block

Outcome Measures

Primary Outcomes (1)

  • Ambulation distance

    Less meters means worse outcome

    postoperative day 1

Secondary Outcomes (11)

  • Ambulation distance

    postoperative day 2

  • Timed up and go test

    postoperative day 1

  • Timed up and go test

    postoperative day 2

  • 10 meters walk test

    postoperative day 1

  • 10 meters walk test

    postoperative day 2

  • +6 more secondary outcomes

Other Outcomes (2)

  • intravascular local anesthetic injection

    30 day

  • neuropathy after the procedure

    30 day

Study Arms (2)

Single-shot adductor canal block

EXPERIMENTAL
Procedure: Single-shot adductor canal block

Continuous femoral nerve block

ACTIVE COMPARATOR
Procedure: Continuous femoral nerve block

Interventions

Single-shot adductor canal blockPROCEDURE

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.

Single-shot adductor canal block
Continuous femoral nerve blockPROCEDURE

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.

Continuous femoral nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital on Yauza

Moscow, 111033, Russia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeAgnosia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valery Likhvantsev

    Negovsky Reanimatology Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valery Likhvantsev

CONTACT

+79036235982lik0704@gmail.com

Levan Berikashvili

CONTACT

+79263308968levan.berikashvili@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Research V. Negovsky Reanimatology Research Institute

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 4, 2022

Study Start

February 3, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)