Clinical trial NCT02257164: Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial
Official title: Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: anterior cruciate ligament reconstruction
femoral nerve block
articular injection and obturator nerve block
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: number of patients with success
timeFrame: 4 postoperative hours
Secondary outcomes:
measure: Pain for all patients
timeFrame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
measure: analgesic consumption for all patients
timeFrame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
measure: analgesic adverse events for all patients
timeFrame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: PASSOT
Study officials:
affiliation: CHU de Saint-Etienne
name: Sylvie PASSOT, MD
role: PRINCIPAL_INVESTIGATOR
References: