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

NCT ID: NCT02257164

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-05-31

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

Conditions

Anterior Cruciate Ligament Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

femoral nerve block

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

Group Type: ACTIVE_COMPARATOR

Femoral nerve block

Intervention Type: PROCEDURE

2 mg/ml

obturator nerve block and intraarticular injection

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

Group Type: EXPERIMENTAL

obturator nerve block

Intervention Type: PROCEDURE

intraarticular injection

Intervention Type: PROCEDURE

Interventions

Femoral nerve block

2 mg/ml

Intervention Type: PROCEDURE

obturator nerve block

Intervention Type: PROCEDURE

intraarticular injection

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie PASSOT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

PASSOT

Saint-Etienne, , France

Countries

France

Other Identifiers

2014-002062-77

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1408021

Identifier Type: -

Identifier Source: org_study_id