NCT02873637

Brief Summary

The main objective of this study is to show that postoperative Total Knee Replacement (TKR), an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor quadriceps femoral perineural catheter that (KTF) infused with even low doses of local anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking of the knee feasible at the bedside. Patients will be randomized in two arms:

  • catheter in position under sartorial (experimental group)
  • femoral catheter (control group)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2018

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

August 12, 2016

Last Update Submit

November 27, 2025

Conditions

Total Knee Replacement

Keywords

total knee replacementanesthesiacatheter

Outcome Measures

Primary Outcomes (1)

  • International clinical score Daniels and Worthingham

    This score measures the driving force of the quadriceps (scale M0: no contraction in M5: normal force)

    2 day after surgery (total knee replacement)

Study Arms (2)

under sartorial catheter

EXPERIMENTAL

catheter under sartorial

Device: under sartorial catheter

femoral catheter

OTHER

femoral catheter

Device: femoral catheter

Interventions

under sartorial catheterDEVICE
under sartorial catheter
femoral catheterDEVICE
femoral catheter

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major Patient (≥ 18 years)
  • Before tricompartmental benefit from knee replacement (TKR) unilateral,
  • TKR programmed on one of the first three days of the week (Monday to Wednesday)
  • Physical status score I-III,
  • Non septic programmed surgery under general anesthesia
  • Able to understand the protocol
  • Written informed consent
  • Social Insured
  • Opportunity to be followed under the Protocol

You may not qualify if:

  • Age ≥ 85 years
  • Obesity (BMI ≥ 35)
  • Revision TKR,
  • Patients not cooperating or not including the French,
  • Difficulties in understanding and evaluating the score pain (VAS),
  • Preoperative cognitive dysfunction making unreliable interrogation
  • Patient unable to read and / or write (literacy, ...)
  • Known bleeding disorders,
  • Vascular surgery for femoral vessels on the operated side,
  • Neuropathy of the lower limb,
  • Localized infection at the puncture catheters,
  • Known allergy to ropivacaine,
  • Renal and / or severe hepatic impairment,
  • Taking opioids for more than a month before surgery,
  • Intolerance to morphine,
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHD Vendée de la Roche sur Yon

La Roche-sur-Yon, 85925, France

Location

Related Publications (1)

  • Guilley J, Besancon I, Hivert A, Plouhinec AM, Oudot M, Venet G, Fraquet N, Cousin J, Planche L, Ganiere C, Duchalais A. Femoral nerve inguinal approach versus proximal femoral triangle ap proach for continuous regional analgesia in active rehabilitation after total knee arthroplasty: A prospective, randomised study. Anaesth Crit Care Pain Med. 2022 Apr;41(2):101043. doi: 10.1016/j.accpm.2022.101043. Epub 2022 Feb 19.

    PMID: 35189397RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 19, 2016

Study Start

January 1, 2017

Primary Completion

September 11, 2018

Study Completion

November 11, 2018

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)