Hôpital Edouard Herriot - Département d'anesthésie réanimation
Lyon, 69437, France
NCT Number: NCT02720471
Clinical study, comparative, prospective, interventional, randomized, single-center, single-blind The fast resumption of the walking after surgery of total prosthesis of hip (PTH) requires an effective analgesia from the immediate post-operative period. In France, whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United States, the techniques of peroperative infiltration of local anesthetics (IAL) by the surgeon supplanted the techniques of traditional ALR. However, no French study compares the IAL with the conventional ALR with a rigorous methodology. Our occasional practice of IAL suggests us that it is more effective in terms of post-operative analgesia with Analog Visual Scales decreased (EVA) and a lesser consumption of morphine. Furthermore, the resumption of the upright posture in bipedal support as well as the resumption of the walking would be earlier.
The main objective is to show that the post-operative analgesia by local peroperative infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block associated with a side cutaneous block of the thigh) after the surgery of total prosthesis of hip, with decrease of the consumption of morphine within first 72 post-operative hours.
The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest and with the mobilization during various times (in post-surgery care room, then at H4, H8, H12, H24, H48, H72), the period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal support), the period between the end of intervention and the resumption of the walk, the satisfaction of the patients at the exit of the hospital, the duration of hospitalization after the surgical operation and the possible unwanted events (systematic toxicity of the local anesthetics, the infection of prosthesis, disease thromboembolic venous) during the hospitalization.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Lyon, 69437, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
classical analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh
peroperative infiltration of local anesthetics
Time frame: 72 hours after surgery
Morphine consumption will be measured within the 72 hours following surgery
Time frame: 72 hours after surgery
Visual analogic pain scale (EVA) will be used to evaluate patient's pain at rest within the 72 hours following surgery
Time frame: 72 hours after surgery
Visual analogic pain scale (EVA) will be used to evaluate patient's pain while moving within the 72 hours following surgery
Time frame: From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery
Period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal station.
Time frame: From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery
Hospices Civils de Lyon
Other
Acronym: ALRIAL
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