Clinical Trial Results:
Femoral nerve inguinal approach (FNB-Cath)versus proximal femoral triangle approach (FTB-Cath) for continuous regional analgesia in active rehabilitation after
total knee arthroplasty: A prospective, randomised study
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Summary
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EudraCT number |
2016-001519-19 |
Trial protocol |
FR |
Global end of trial date |
14 Dec 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Sep 2022
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First version publication date |
03 Sep 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CHD050-16
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02873637 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Centre Hospitalier Départemental Vendée
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Sponsor organisation address |
Bd Stéphane Moreau, La Roche sur Yon, France, 85923
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Public contact |
Agnès DORION, Centre Hospitalier Départemental Vendée, +33 251446380, agnes.dorion@ght85.fr
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Scientific contact |
Dr Jérôme GUILLEY, Centre Hospitalier Départemental Vendée, jerome.guilley@ght85.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Apr 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Dec 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
demonstrate that the nerve block administration for analgesic purposes via an FTB-Cath results in less quadriceps weakness than via an FNB-Cath.
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Protection of trial subjects |
Treated in routine care
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Background therapy |
Gabapentine (Neurontin®) - night before and procedure’s morning - 600 mg Céfuroxime (Zinnat®) - 30mn to 1h before the beginning of the intervention- 1,5g (3g si BMI >30) Acide tranexamique (Exacyl®) - 1g ()2 injections Dexaméthasone – one time intraoperative - 8 mg IV Paracétamol - for the duration of the hospital stay – 4g per day Kétoprofène – day 0 to day 4 - 100 mg (2 times per day) Oxycodone (Oxynorm® IV , Oxycontin PO) - for the duration of the hospital stay - 5 to 10 mg every 4 to 6 hours Ondansétron – day 0 to day 1 - 1 ampoule of 4 mg IV Enoxaparine sodique (Lovenox®) – day 1 to day 21 - 4000 U subcutaneous Apixaban (Eliquis®) - day 1 to day 21 - 2.5 mg PO (2 times per day) Rémifentanil - intraoperative - 0,5 à 1 µg/kg/mn Propofol - intraoperative - 1,5 à 2 mg/kg Desflurane - intraoperative Atracurium - intraoperative - 0,5mg/kg | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Jan 2017
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy, Scientific research | ||
Long term follow-up duration |
2 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 44
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Worldwide total number of subjects |
44
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EEA total number of subjects |
44
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
6
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From 65 to 84 years |
38
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85 years and over |
0
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Recruitment
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Recruitment details |
Inclusion period: 24 months First inclusion: 2017/01/17 Last inclusion: 2018/09/11 | |||||||||||||||||||||
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Pre-assignment
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Screening details |
The screening visit verifies that the patient meets the inclusion criteria. the subject give his consent for written participation after presentation by the investigator of the study, reading of the informed consent form and response of the investigator to his questions. | |||||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||||||||||||||
Roles blinded |
Subject | |||||||||||||||||||||
Blinding implementation details |
Blinding is respected by positioning a blinding dressing that covers the 2 catheter insertion sites. The patient cannot then visualize the catheter's location
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Femoral triangle catheter (FTB-Cath) | |||||||||||||||||||||
Arm description |
echo-guided placement of the KTSS catheter at the junction of the thigh inserted 3 cm into the paravascular space under the sartorial suture (puncture site 14-15 cm below the inguinal ligament) | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Ropivacaine
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Investigational medicinal product code |
N01BB09
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
462mg
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Arm title
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Catheter in Femoral nerve block (FNB-Cath) | |||||||||||||||||||||
Arm description |
coupled placement with untrasound guidance and neurostimulation of the femoral KTF at the level of the inguinal fold introduced over 3 to 5 cm in contact with the nerve with search for a motor response in ascent of the patella or contraction of the vastus medialis muscle to the neurostimulation performed by the KT in place, at an intensity if possible < 1mA for a stimulation duration of 100 µs | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Ropivacaine
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Investigational medicinal product code |
N01BB09
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
462mg
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Baseline characteristics reporting groups
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Reporting group title |
Femoral triangle catheter (FTB-Cath)
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Reporting group description |
echo-guided placement of the KTSS catheter at the junction of the thigh inserted 3 cm into the paravascular space under the sartorial suture (puncture site 14-15 cm below the inguinal ligament) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Catheter in Femoral nerve block (FNB-Cath)
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Reporting group description |
coupled placement with untrasound guidance and neurostimulation of the femoral KTF at the level of the inguinal fold introduced over 3 to 5 cm in contact with the nerve with search for a motor response in ascent of the patella or contraction of the vastus medialis muscle to the neurostimulation performed by the KT in place, at an intensity if possible < 1mA for a stimulation duration of 100 µs | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Femoral triangle catheter (FTB-Cath)
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Reporting group description |
echo-guided placement of the KTSS catheter at the junction of the thigh inserted 3 cm into the paravascular space under the sartorial suture (puncture site 14-15 cm below the inguinal ligament) | ||
Reporting group title |
Catheter in Femoral nerve block (FNB-Cath)
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Reporting group description |
coupled placement with untrasound guidance and neurostimulation of the femoral KTF at the level of the inguinal fold introduced over 3 to 5 cm in contact with the nerve with search for a motor response in ascent of the patella or contraction of the vastus medialis muscle to the neurostimulation performed by the KT in place, at an intensity if possible < 1mA for a stimulation duration of 100 µs | ||
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End point title |
Quadriceps strength | |||||||||
End point description |
quadriceps strength assessed clinically on postoperative day (POD) 2 by the Manual Muscle Test (MMT) using a motor grading scores
[Daniels and Worthingham's international clinical score (scores 0–5)].
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End point type |
Primary
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End point timeframe |
postoperative day 2
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Statistical analysis title |
Quadriceps driving force | |||||||||
Comparison groups |
Catheter in Femoral nerve block (FNB-Cath) v Femoral triangle catheter (FTB-Cath)
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
≤ 0.05 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
From randomization (on the day of the intervention) until the patient's discharge (M2 post-operative)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
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Reporting groups
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Reporting group title |
catheter under sartorial
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Reporting group description |
echo-guided placement of a KTSS catheter at the junction of the thigh inserted 3 cm into the paravascular space under the sartorial suture (puncture site 14-15 cm below the inguinal ligament). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
femoral catheter
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Reporting group description |
Coupled placement with ultrasound guidance and neurostimulation (outside the ultrasound field) of a femoral KTF at the level of the inguinal fold introduced over 3 to 5 cm in contact with the nerve with search for a motor response in ascent of the patella or contraction of the vastus medialis muscle to the neurostimulation performed by the KT in place, at an intensity if possible < 1mA for a stimulation duration of 100µs. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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04 Oct 2016 |
Modification of intraoperative patient management:
Possibility of emergency analgesia:
- if EVA >40, 5 ml perivicaine perivacaine
- if EVA >60, additional addition of Oxynom IV |
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04 Jan 2017 |
addition of a secondary objective: comparison of the rate of adverse events between the 2 arms |
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08 Dec 2017 |
Extension of the study duration by 12 months |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
