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NCT Number: NCT02257164

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

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

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PASSOT

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral Nerve Block

Procedure

2 mg/ml

Obturator nerve block

Procedure

Intraarticular injection

Procedure

Primary outcomes

  1. number of patients with success

    Time frame: 4 postoperative hours

    success is defined by : score chung > or egal to 9 and quadriceps locking > or egal to 3/5

Secondary outcomes

  1. Pain for all patients

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

    pain measured by EVA

  2. analgesic consumption for all patients

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

    analgesic consumption of tramadol and morphine (use, number)

  3. analgesic adverse events for all patients

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

    Frequency of nausea and vomiting

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: CLICA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2014
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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