Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement

Not Applicable

Completed

• Conditions: Total Knee Replacement
• Interventions: Device: under sartorial catheter; Device: femoral catheter

• Registration Number: NCT02873637
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-19
• Study Start: 2017-01
• Primary Completion: 2018-09-11
• Study Completion: 2018-11-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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

Exclusion Criteria

• 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,
• Rheumatic inflammatory disease,
• Patients receiving immunosuppressive therapy or long-term corticosteroid
• Allergy or against-indications to standard treatments administered intraoperative and postoperative
• Flexion deformity> 10 ° or valgus deformity with significant
• Refused to participate
• Patient trusteeship, guardianship, deprived of liberty
• Women premenopausal who become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
under sartorial catheter	under sartorial catheter	catheter under sartorial
femoral catheter	femoral catheter	femoral catheter

Primary Outcome Measures

Name	Time	Method
International clinical score Daniels and Worthingham	2 day after surgery (total knee replacement)	This score measures the driving force of the quadriceps (scale M0: no contraction in M5: normal force)

Trial Locations

Locations (1)

CHD Vendée de la Roche sur Yon; 🇫🇷 La Roche sur Yon, France