NCT03038958
Completed
Phase 4
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy
Centre Hospitalier Universitaire Saint Pierre2 sites in 1 country80 target enrollmentApril 2016
Overview
- Phase
- Phase 4
- Intervention
- Isobaric 2-chloroprocaine
- Conditions
- Knee Arthroscopy
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Duration of sensory block
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects
Investigators
Eligibility Criteria
Inclusion Criteria
- •American Society of Anesthesiology physical status (ASA) ≤ III
- •Age 18-80 year
- •Height between 160 and 185 cm
- •Signed informed consent obtained prior to any study specific assessments and procedures
Exclusion Criteria
- •Cardiac pathology (such as Heart failure, Aortic stenosis)
- •Coagulation disorders (INR\>1.3, platelet \< 80 000/mm3)
- •Known allergy to local anaesthetics
- •Disagreement of the patient
Arms & Interventions
Isobaric 2-chloroprocaine
The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy
Intervention: Isobaric 2-chloroprocaine
Hyperbaric prilocaine 2%
The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy
Intervention: Hyperbaric prilocaine
Outcomes
Primary Outcomes
Duration of sensory block
Time Frame: Until complete release of sensory block
Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block
Secondary Outcomes
- Onset time of sensory block(up to 30 minutes)
- Duration of motor block(Until complete regression of motor block)
- Side-effects (hypotension, bradycardia, urinary retention)(up to 24 hours)
- Pain assessed by Visual Analog Scale(up to 24 hours)
- Onset time of motor block(up to 30 minutes)
Study Sites (2)
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