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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02257164
Acronym
CLICA
Enrollment
48
Registered
2014-10-06
Start date
2014-11-30
Completion date
2015-05-31
Last updated
2015-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

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

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

Interventions

PROCEDUREFemoral nerve block

2 mg/ml

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
number of patients with success4 postoperative hourssuccess is defined by : score chung \> or egal to 9 and quadriceps locking \> or egal to 3/5

Secondary

MeasureTime frameDescription
Pain for all patientsPostoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48pain measured by EVA
analgesic consumption for all patientsPostoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48analgesic consumption of tramadol and morphine (use, number)
analgesic adverse events for all patientsPostoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48Frequency of nausea and vomiting

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026