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Chirocaine for Pain Management in ACL Reconstruction
NCT00620477Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2008
- Primary completion
- Nov 2010
- Countries
- 1
- Sponsor
- Ghent University Hospital
- Modality
- Small Molecules
- Drugs
- levobupivacaine
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial in postoperative pain comparing Chirocaine Arm with Placebo Arm (2 arms). Primary endpoint: Visual Analogue Scale at 4 hours. Started Jul 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Chirocaine Arm
Injection of 20 ml of chirocaine 0.125% into the knee joint.
Placebo Arm
Injection of 20 ml of physiological fluid into the knee joint.
03
Who it enrols
Patients with isolated ACL rupture and knee instability, including those with suturable meniscal tears or partial meniscectomies, excluding those with chronic laxity (>9 months) or significant joint pathology.
04
Endpoints
Primary
Visual Analogue Scale
Secondary
Question Form
Visual Analogue Scale
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