Infiltration or Nerve Blocks in Addition to Adductor Canal Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche
About this trial
The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult male or female
Patient with signed consent to participate in the study,
Patient with uni or bilateral primary gonarthrosis
Indication for total knee arthroplasty.
Disqualifiers
History of knee fracture, arthroplasty or osteotomy
Known or unknown contraindication to ALR or locoregional anesthesia products
Neurological disease, stroke sequelae
Mental deficiency or any other reason that may hinder understanding or strict application of the protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Analgesia
Procedure/Surgery1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum
Analgesia
Procedure/Surgery2- Real Adductor canal block + femoral-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group 1 of local analgesia protocol (PROSPECT recommandations)Sham comparator 1 intervention
Group B: Group 2 of local analgesia protocol (quadri-peripheral nerve block )Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score
The QoR-15 score at H24 after surgery was compared between the two groups for primary endpoint analysis. The QoR-15 accurately measures postoperative recovery by focusing on 5 key domains: pain, physical comfort, physical independence, psychological support and emotional state. Each item is rated from 0 (unfavorable) to 10 (favorable), with an overall score corresponding to the sum of the score obtained for each item, i.e. a score from 0 (no recovery) to 150 (full recovery).
Time frame
From enrollement to the last H24 after surgerySecondary outcomes
1
Knee functional assessment
Functional assessment of the knee with KOOS JR questionnaire
Time frame
Hour 02
Post operative pain
Pain measured with a simple numeric scale
Time frame
Hour 23
Post operative pain
Pain measured with a simple numeric scale
Time frame
Hour 64
Post operative pain
Pain measured with a simple numeric scale
Time frame
Hour 12Sponsors and contacts
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Source ClinicalTrials.gov