Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement (ALRIAL)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Men or women > or = 18 years old
- Surgery for total hip replacement (THR)
- Unilateral THR
- First THR
- THR planned because of a degenerative disease or after a traumatism
- Whatever the technique of anesthesia (general anesthesia or intra thecal anesthesia)
- Whatever the surgery technique/surgical approach
- Patient with a social security protection
- Patient not under juridic protection
- Agreement for the study signed by the patient himself or, if he is not able to sign, by his trusted person.
Exclusion criteria
- Patient Refusal
- Second hip replacement
- Pregnancy or breastfeeding
- Porphyria
- Risks to have methemoglobinemia (G6PD deficit, hemoglobin disease)
- BMI> 40 kg/m2 ou < 18 kg/m2
- Allergy to any of the drugs used in this study
- Contraindication to any of the technic used in this study
- Factors wich could influence the perception of pain (depression, dementia, psychiatric illness, neurologic disease with sensitivity troubles)
- Usual consumption of opioids
- Systemic or articular infection
- Participation to an other research that could interfere in this study
Trial design
Primary purpose
Allocation
Interventional model
Masking
84 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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