Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial

Study Overview
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Brief Summary
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Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery. The post-operative pain of this surgery is managed according to recommendation. In the majority of case, femoral nerve block is performed. The femoral nerve block can cause paralysis of the quadriceps more or less complete that no allowing a good quadriceps locking. This locking is indispensable to avoid post-operative flexima and to ensure stabilization of the knee during walking. In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain requires powerful analgesics with their adverse events. Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in the same time optimal analgesia and optimal quadriceps locking. The main objective of the investigators study is to compare two analgesia techniques : femoral nerve block vs intra articular injection and obturator nerve block in surgery of the anterior cruciate ligament of the knee

Official Title
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Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Procedure: Femoral nerve block
* Procedure: obturator nerve block
* Procedure: intraarticular injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physical Status score = 1 or Physical Status score = 2 Major Patient indication of anterior cruciate ligament reconstruction informed consent for participation in the study Exclusion Criteria: Contraindication to general analgesia Contraindication to peripheral nerve block Allergy to analgesic treatment Porphyria, Neurologic deficit Contraindication antiinflammatory drugs Simultaneous reconstruction of another ligament or complex gesture intended Patient treated with an anti-arrhythmic drug class III Patient with severe hepatic impairment Pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: femoral nerve block<br>20 ml injection of 2 mg/ml ropivacaine in femoral nerve | Procedure: Femoral nerve block<br>* 2 mg/ml<br>|
| Experimental: obturator nerve block and intraarticular injection<br>10 ml injection of 2 mg/ml ropivacaine in obturator nerve intraarticular injection : 10 ml of chlorhydrate ropivacaine (2 mg/ml) and 10ml of magnesium sulfate | Procedure: obturator nerve block<br> <br> Procedure: intraarticular injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with success | success is defined by : score chung > or egal to 9 and quadriceps locking > or egal to 3/5 | 4 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain for all patients | pain measured by EVA | Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48 | 
| analgesic consumption for all patients | analgesic consumption of tramadol and morphine (use, number) | Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48 | 
| analgesic adverse events for all patients | Frequency of nausea and vomiting | Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cruciate ligament reconstruction, femoral nerve block, articular injection and obturator nerve block