Pharmacokinetic, Pharmacodynamic and Pharmacogenetic of Morphine After Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00822549
• Date of registration: 13/01/2009
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Pharmacokinetic, Pharmacodynamic and Pharmacogenetic of Morphine After Surgery
• Scientific title: Assessment of the Pharmacokinetic, Pharmacodynamic, Pharmacogenetic Relationships of Morphine and Metabolites After Severe Postoperative Pain in Adults
• Date of first enrolment: September 2006
• Target sample size: 438
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00822549
• Study type: Observational
• Study design: Time Perspective: Cross-Sectional
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Frederic Aubrun, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Orthopaedic Surgery

Intervention(s)

Drug: intravenous morphine titration

Primary Outcome(s)

To improve our knowledge on the pharmacodynamic, pharmacokinetic and pharmacogenetic relationships of morphine administered after severe postoperative pain. [Time Frame: during the study]

Secondary Outcome(s)

- Relationships between clinical events (pain relief, failure in pain relief, adverse effects) and genetic polymorphism. [Time Frame: Immediate postoperative period (PACU)]

- Relationships between morphine consumption, clinical events (efficacy or adverse effects) and morphine (and metabolites) blood concentrations. Immediate postoperative period (PACU) [Time Frame: Immediate postoperative period (PACU)]

- Relationships between sub-acute clinical events and PK/PG profile. (on the wards at 24 hours after surgery) [Time Frame: on the wards at 24 hours after surgery]

To better characterize the age- and sex-related differences which differ between acute and sub-acute periods. [Time Frame: during the study]

Secondary ID(s)

AOR 05038

Source(s) of Monetary Support

Please refer to primary and secondary sponsors