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Levobupivacaine vs Bupivacaine in Anorectal Surgery
NCT04245774Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2007
- Primary completion
- Aug 2008
- Sponsor
- Gazi University
- Modality
- Small Molecules
- Drugs
- levobupivacaine
- Conditions
- Anorectal disorder
01
Overview
Phase 4, randomised, double-blind trial of levobupivacaine in Anorectal disorder (2 arms), sponsored by Gazi University. Primary endpoints: Adequate level of anesthesia for surgery at 20 months, Time to obtain maximum sensory block and 6 more. Started Nov 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Levobupivacaine
7.5 mg hyperbaric levobupivacaine intrathecal
Bupivacaine
7.5 mg hyperbaric bupivacaine intrathecal
03
Who it enrols
Patients aged 18-50 with ASA I-II risk status scheduled for elective anorectal surgery, excluding those with hypersensitivity to amide-type local anesthetics or contraindications for spinal anesthesia.
04
Endpoints
Primary
Adequate level of anesthesia for surgery
Time to obtain maximum sensory block
The highest level of sensory block
Two segment regression time of sensory block
The end time of sensory block
Secondary
Heart rate
Systolic, Diastolic, and Mean Arterial Pressure
Peripheral oxygen saturation
First analgesic requirement
First mobilization time
First voiding time
Patient satisfaction
Surgeon satisfaction
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