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

NCT02257164 | Completed Phase 4

• 2 other identifiers: 14080212014-002062-77
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

anterior cruciate ligament reconstruction; femoral nerve block; articular injection and obturator nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain for all patients

  Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48

• analgesic consumption for all patients

  Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48

• analgesic adverse events for all patients

  Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48

Study Arms (2)

femoral nerve block

ACTIVE COMPARATOR

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

Procedure: Femoral nerve block

obturator nerve block and intraarticular injection

EXPERIMENTAL

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

Interventions

Femoral nerve block PROCEDURE

2 mg/ml

femoral nerve block

obturator nerve block PROCEDURE

obturator nerve block and intraarticular injection

intraarticular injection PROCEDURE

obturator nerve block and intraarticular injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical Status score = 1 or Physical Status score = 2
• Major Patient
• indication of anterior cruciate ligament reconstruction
• informed consent for participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

PASSOT

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Injections, Intra-Articular

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sylvie PASSOT, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 6, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 1, 2015

Record last verified: 2015-01

Locations

FR (1)