CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
LIA of the posterior capsule of the knee +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01966263
NCT01966263Phase 4Completed

Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block

Sint Maartenskliniek·interventional·Posted Oct 21, 2013·Updated Jan 25, 2023

In Brief

A Phase 4 clinical trial evaluating LIA of the posterior capsule of the knee, LIA of the anterior capsule of the knee, and 2 other interventions for Arthroplasty, Replacement, Knee. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 21, 2013
Enrollment StartNov 1, 2013
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.7 years ago

Interventions

LIA of the posterior capsule of the kneeprocedure

the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.

LIA of the anterior capsule of the kneeprocedure

the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.

LIA of the subcutaneous tissue of the kneeprocedure

the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.

FNB with catheterprocedure

pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours