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

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

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Procedure: obturator nerve block; Procedure: Femoral nerve block; Procedure: intraarticular injection

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42055
    • PASSOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: femoral nerve block; 20 ml injection of 2 mg/ml ropivacaine in femoral nerve	Procedure: Femoral nerve block; 2 mg/ml
Experimental: 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	Procedure: obturator nerve block; Procedure: intraarticular injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Sylvie PASSOT, MD, Chu de Saint-Etienne

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: femoral nerve block; anterior cruciate ligament reconstruction; articular injection and obturator nerve block
• Other Study ID Numbers: 1408021; 2014-002062-77 (EudraCT Number)