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Clinical Trials/NCT02257164
NCT02257164
Completed
Phase 4

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country48 target enrollmentNovember 2014

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Reconstruction
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
48
Locations
1
Primary Endpoint
number of patients with success
Status
Completed
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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