CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 287 enrolled / 287 target
Drug / intervention
Ropivacaine +1 moredrug
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/NCT03998813
NCT03998813N/ACompletedOn Track (4.1/mo)Completion was 36mo ago

Chronic Pain and Functional Prognosis After Total Knee Replacement: Continuous Locoregional Analgesia by Catheter to the Femoral Triangle Versus Tissue Infiltration as Part of an Improved Rehabilitation After Surgery Approach

Centre Hospitalier Departemental Vendee·interventional·Posted Jun 26, 2019·Updated Jun 12, 2026

In Brief

A clinical study evaluating Ropivacaine for Knee Pain Chronic. Completed, enrolled 287 participants across 5 sites.

Detailed Summary

The prevalence of Chronic Post-Surgical Pain (CPSP) after knee replacement, defined as pain greater than or equal to 4/10 on the visual analogue scale after the third postoperative month, is recognised as high, with an average of 20% (extremes of 7 to 45%). These CPSP, when present, cause poor long-term joint functional prognosis and impaired quality of life for patients. Many predictive, pre-, per- and post-operative factors of these CPSP have been identified in recent years. The most common postoperative risk factor found in the literature is the intensity of early pain. The treatment protocols for this early post-surgical pain are currently and mainly multimodal in nature, combining systemic analgesics (paracetamol, NSAIDs, morphine, gabapentins) and local anaesthetics, administered either in the form of peripheral nerve blocks (continuous or single injection) or in the form of tissue infiltration (TI) performed by the surgeon during the operation. Very few of these techniques have been evaluated for their ability to reduce the incidence of CPSP. Drugs with antihyperalgesic properties such as ketamine or nefopam have been shown to be of no interest, except to reduce the proportion of pain of a neuropathic nature. Only the continuous femoral block has shown, to date, an interest in IT to reduce the incidence of these CPSP. The main objective of this study is to show that a multimodal analgesia protocol based on continuous locoregional analgesia by femoral triangle catheterization could reduce the incidence of chronic post surgical pain compared to a protocol based on tissue infiltration.

Study Details

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

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 26, 2019
Enrollment StartSep 2, 2020
Primary CompletionJun 26, 2023
Study CompletionApr 8, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.0 years ago

Arms & Interventions

Locoregional analgesia by femoral triangle catheterizationexperimental

Drug: Ropivacaine
Tissue infiltrationactive_comparator

Drug: Ropivacaine

Interventions

Ropivacainedrug

Locoregional analgesia by femoral triangle catheterization

Ropivacainedrug

Tissue infiltration