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Therapeutic essay of phase IV, monocentric, prospective, randomized, in double-blind during 48 hours(then simple-blind),controlled by placebo.
Abstract:
The increasing incidence of the number of femoral neck fractures and the poor prognosis of this traumatological pathology involves an optimization of the diagnostic, therapeutic and analgesic care.
A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection ("single shot") of local anesthetic with the technique of the femoral or iliofascial block. Nevertheless the single injection of a dose of local anesthetic associated or not with analgesic adjuvants, due to their pharmacological properties, can't prolong the efficiency of the loco-regional analgesia more than 12 hours.
The aim of our study is to evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacaïne controlled by placebo (physiological serum).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physiological serum | Placebo Comparator | ropivacaïne controlled by placebo (physiological serum). |
|
| ropivacaine | Active Comparator | ropivacaïne controlled by placebo (physiological serum). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine | Drug | A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection of local anesthetic with the technique of the femoral or iliofascial block. Intervention: Analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacaïne controlled by placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter | from the hospital admission to 24h after surgical operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume BOUHOURS | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHAngers | Angers | 49 933 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33238043 | Derived | Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3. |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |