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

Phase 4

Completed

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Procedure: Femoral nerve block; Procedure: obturator nerve block; Procedure: intraarticular injection

• Registration Number: NCT02257164
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-06
• Study Start: 2014-11
• Status Verified: 2015-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
obturator nerve block and intraarticular injection	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
femoral nerve block	Femoral nerve block	20 ml injection of 2 mg/ml ropivacaine in femoral nerve
obturator nerve block and intraarticular injection	obturator nerve block	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

Primary Outcome Measures

Name	Time	Method
number of patients with success	4 postoperative hours	success is defined by : score chung \> or egal to 9 and quadriceps locking \> or egal to 3/5

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PASSOT; 🇫🇷 Saint-etienne, France