Status:
COMPLETED
Pharmacokinetic, Pharmacodynamic and Pharmacogenetic of Morphine After Surgery
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Orthopaedic Surgery
Eligibility:
All Genders
18+ years
Brief Summary
The main objective of this study is to improve our knowledge on the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe postoperative pain. Th...
Detailed Description
No previous study attempted to characterize the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine in the early postoperative period, whereas it is the main clinical situa...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- scheduled major orthopedic surgery
- spine, hip or knee surgery
- Body weight between 50 and 100 kg
- Caucasians
- ASA status 1 to 3
- no cognitive dysfunction
- Exclusion criteria :
- allergy or contraindication to morphine
- renal impairment (Cr Cl \< 30 ml/min)
- severe hepatic impairment
- surgery performed under regional anaesthesia
- preoperative treatment including strong or weak opioids
- pregnancy, patients under 18 years, addiction
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT00822549
Start Date
September 1 2006
End Date
December 1 2010
Last Update
December 11 2012
Active Locations (1)
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1
Hopital de la Pitié Salpêtrière
Paris, France, 75013