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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02496-41 | Other Identifier | N° ID-RCB (ANSM) |
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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).
In addition to the adductor canal block, this quadruple block incorporates :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 of local analgesia protocol (PROSPECT recommandations) | Sham Comparator | Locoregional analgesia (LRA) protocol n°1 : adductor canal block + surgical infiltration (PROSPECT recommendations) |
|
| Group 2 of local analgesia protocol (quadri-peripheral nerve block ) | Experimental | Locoregional analgesia (LRA) protocol n° 2 : adductor canal block + femoral-cutaneous block + obturator block + IPACK block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgesia | Procedure | 1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollement to the last H24 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Knee functional assessment | Functional assessment of the knee with KOOS JR questionnaire | Hour 0 |
| Post operative pain | Pain measured with a simple numeric scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Claude Galien | Recruiting | Quincy-sous-Sénart | 91480 | France |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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Category 2 Research Involving the Human Person (RIPH 2) :
Multi-center (2 sites), prospective, double-blind randomized, study of two parallel groups of patients undergoing total knee arthroplasty according to locoregional analgesia (LRA) protocol :
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| Analgesia | Procedure | 2- Real Adductor canal block + femoral-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum |
|
| Hour 2 |
| Post operative pain | Pain measured with a simple numeric scale | Hour 6 |
| Post operative pain | Pain measured with a simple numeric scale | Hour 12 |
| First ambulation | time between end of intervention and first ambulation | Hour 12 |
| Post operative pain | Pain measured with a simple numeric scale | Hour 24 |
| Joint range of both knees | Measurement of the joint range of both knees | Hour 24 |
| First ambulation | time between end of intervention and first ambulation | Hour 24 |
| Post operative pain | Pain measured with a simple numeric scale | Hour 48 |
| Quality of recovery | Quality of recovery measured with QoR 15 questionnaire | Hour 48 |
| Opioid drug use | Opioid drug use evaluation | Hour 48 |
| Non-opioid drug use | Non-opioid drug use evaluation | Hour 48 |
| Joint range of both knees | Measurement of the joint range of both knees | Hour 48 |
| First ambulation | time between end of intervention and first ambulation | Hour 48 |
| Length of stay in the post-intervention monitoring room | Length of stay in the post-intervention monitoring room | Hour 48 |
| Post operative pain | Pain measured with a simple numeric scale | Month 1 |
| Joint range of both knees | Measurement of the joint range of both knees | Month 1 |
| Length of hospitalisation | Length of hospitalisation | Month 1 |
| Return to patient usual activities | Time taken for the patient to return to their usual activities | Month 1 |
| Drug tolerance | Drug tolerance | Month 1 |
| Patient comfort | Patient comfort during loco-regional anesthesia | Hour 1 |
| Knee functional assessment | Functional assessment of the knee with KOOS JR questionnaire | Month 1 |
| Clinique des Côtes du Rhône | Not yet recruiting | Roussillon | 38150 | France |
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| D012216 |
| Rheumatic Diseases |