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PROSPECTIVE, RANDOMIZED, DUOBLE BLIND COMPARISON BETWEEN SUBARACNOID ANAESTHESIA AND SUBARACNOID ANAESTHESIA WITH BLOCK OF FEMORAL NERVE IN PATIENTS UNDERGOING SURGERY FOR ANTERIOR LIGAMENT REPAIR. - ND

Phase 1
Conditions
PATIENTS UNDERGOING SURGERY FOR CRUSADER ANTERIOR LIGAMENT
MedDRA version: 9.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disorders
Registration Number
EUCTR2007-000421-21-IT
Lead Sponsor
OSPEDALE S. RAFFAELE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

PATIENTS UNDERGOING SURGERY FOR CRUSADER ANTERIOR LIGAMENT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

pregnancy;patients affected by neuropaties; patients not qualified for subaracnoid anaesthesia coagulation problems,previous surgery to the back lumbar region ;ipersensibility to ketoprofene

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: TO COMPARE THE POSTOPERATIVE ANALGESIA BETWEEN SUBARACNOID ANAESTHESIA WITH BUPIVACAIN AND LOW MORPHINE DOSES AND SUBARACNOID ANAESTHESIA WITH BUPIVACAIN AND FEMORAL NERVE BLOCK WITH LEVOBUPIVACAINE.;Secondary Objective: X;Primary end point(s): TO COMPARE THE POSTOPERATIVE ANALGESIA BETWEEN SUBARACNOID ANAESTHESIA WITH BUPIVACAIN AND LOW MORPHINE DOSES AND SUBARACNOID ANAESTHESIA WITH BUPIVACAIN AND FEMORAL NERVE BLOCK WITH LEVOBUPIVACAINE.
Secondary Outcome Measures
NameTimeMethod
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