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

Anterior Cruciate Ligament Reconstruction Clinical Trial

— CLICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257164
• Other study ID #: 1408021
• Secondary ID: 2014-002062-77
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2014
• Last updated: June 30, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Procedure:
• Femoral nerve block
2 mg/ml
• obturator nerve block

• intraarticular injection

Locations

Country	Name	City	State
France	PASSOT	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pain for all patients	pain measured by EVA	Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48	Yes
Secondary	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	Yes
Secondary	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	Yes