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Tramadol + Levobupivacaine for Post-Cesarean Pain
NCT01916915Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2013
- Primary completion
- Feb 2016
- Countries
- 1
- Sponsor
- Ufuk University
- Modality
- Small Molecules
- Drugs
- tramadol
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial of tramadol in postoperative pain (3 arms), sponsored by Ufuk University. Primary endpoint: Visual Analogue Scale Pain Score at 48 hours. Started Jul 2013; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Tramadol 1 mg/kg
Tramadol 1 mg/kg + 0.25% levobupivacaine
Tramadol 2 mg/kg
Tramadol 2 mg/kg + 0.25% levobupivacaine
Levobupivacaine Only
0.25% levobupivacaine
03
Who it enrols
Women undergoing planned cesarean section, ASA Class I-II, excluding those with morbid obesity (BMI > 30), serious coagulopathy, or systemic disease.
04
Endpoints
Primary
Visual Analogue Scale Pain Score
Secondary
Total Additional Analgesic Consumption
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