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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 4

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Procedure: intraarticular injection; Procedure: obturator nerve block; Procedure: Femoral nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT02257164

1408021

2014-002062-77 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

femoral nerve block

Active Comparator group

Description:

20 ml injection of 2 mg/ml ropivacaine in femoral nerve

Treatment:

Procedure: Femoral nerve block

obturator nerve block and intraarticular injection

Experimental group

Description:

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

Treatment:

Procedure: obturator nerve block

Procedure: intraarticular injection