Trial Outcomes & Findings for 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 (NCT NCT03998813)
NCT ID: NCT03998813
Last Updated: 2026-06-12
Results Overview
Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable). Measure is positive when score is \>= 4
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
287 participants
Primary outcome timeframe
Three months from the intervention
Results posted on
2026-06-12
Participant Flow
Participant milestones
| Measure |
Locoregional Analgesia by Femoral Triangle Catheterization
Ropivacaine: Locoregional analgesia by femoral triangle catheterization
|
Tissue Infiltration
Ropivacaine: Tissue infiltration
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
144
|
|
Overall Study
COMPLETED
|
122
|
119
|
|
Overall Study
NOT COMPLETED
|
21
|
25
|
Reasons for withdrawal
| Measure |
Locoregional Analgesia by Femoral Triangle Catheterization
Ropivacaine: Locoregional analgesia by femoral triangle catheterization
|
Tissue Infiltration
Ropivacaine: Tissue infiltration
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
do not meet inclusion criteria
|
10
|
12
|
Baseline Characteristics
Missing data
Baseline characteristics by cohort
| Measure |
Locoregional Analgesia by Femoral Triangle Catheterization
n=143 Participants
Ropivacaine: Locoregional analgesia by femoral triangle catheterization
|
Tissue Infiltration
n=144 Participants
Ropivacaine: Tissue infiltration
|
Total
n=287 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=143 Participants
|
71 years
n=144 Participants
|
71 years
n=287 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=141 Participants • Missing data
|
77 Participants
n=144 Participants • Missing data
|
150 Participants
n=285 Participants • Missing data
|
|
Sex: Female, Male
Male
|
68 Participants
n=141 Participants • Missing data
|
67 Participants
n=144 Participants • Missing data
|
135 Participants
n=285 Participants • Missing data
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
28.3 kg/m²
n=143 Participants
|
27.4 kg/m²
n=144 Participants
|
28.1 kg/m²
n=287 Participants
|
|
Rest Pain Assessment Scale
|
2 units on a scale
n=143 Participants
|
2 units on a scale
n=144 Participants
|
2 units on a scale
n=287 Participants
|
|
Walking Pain Assessment Scale
|
5 units on a scale
n=143 Participants
|
5 units on a scale
n=144 Participants
|
5 units on a scale
n=287 Participants
|
|
Douleur Neuropathique en 4 questions
|
2 units on a scale
n=143 Participants
|
2 units on a scale
n=144 Participants
|
2 units on a scale
n=287 Participants
|
|
WOMAC Score
|
47 units on a scale
n=143 Participants
|
46 units on a scale
n=144 Participants
|
47 units on a scale
n=287 Participants
|
PRIMARY outcome
Timeframe: Three months from the interventionPopulation: Patient is count when EN at walking is greater or equal to 4
Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable). Measure is positive when score is \>= 4
Outcome measures
| Measure |
Tissue Infiltration
n=122 Participants
Ropivacaine: Tissue infiltration
|
Locoregional Analgesia by Femoral Triangle Catheterization
n=119 Participants
Ropivacaine: Locoregional analgesia by femoral triangle catheterization
|
|---|---|---|
|
Walking Pain Assessment Scale
|
13 Participants
|
19 Participants
|
Adverse Events
Locoregional Analgesia by Femoral Triangle Catheterization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tissue Infiltration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place