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Pharmacokinetic, Pharmacodynamic and Pharmacogenetic of Morphine After Surgery

NCT ID: NCT00822549

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

438 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-12-31

Brief Summary

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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. The analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs sub acute).

Detailed Description

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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 situation for severe pain and a unique model for its study (not possible in the healthy volunteer). Indeed, intravenous titration of morphine is the first step for pain control in the postanesthesia care unit. Administration of intravenous boluses of morphine enables to obtain complete pain relief in 98% of the patients. We intend to study the effects of morphine (intravenous titration then patient-controlled intravenous administration (PCA) for 24 hours), perform dosages of plasma concentration of morphine an its main metabolites, and also study gene polymorphisms coding for main proteins involved in the pharmacokinetic and pharmacodynamic profile of morphine (hepatic metabolism, distribution and elimination, interaction with morphine receptor). Five hundred patients scheduled for major orthopedic surgery will be included in this prospective study. 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. The analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs subacute). We consider that this knowledge is important to confirm or not several important concepts currently used to define the appropriate analgesic regimen to control severe pain in the postoperative period.

Conditions

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Orthopaedic Surgery

Keywords

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Morphine titration Sub acute pain Major orthopaedic surgery Pharmacokinetics Pharmacodynamics Genetic polymorphism PACU Patients undergoing major scheduled orthopaedic surgery

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

all the patients included in the study received intravenous morphine in PACU and in the wards

intravenous morphine titration

Intervention Type DRUG

intravenous morphine titration

Interventions

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intravenous morphine titration

intravenous morphine titration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic Aubrun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital de la Pitié Salpêtrière

Paris, , France

Site Status

Countries

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France

References

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Aubrun F, Zahr N, Langeron O, Boccheciampe N, Cozic N, Belin L, Hulot JS, Khiami F, Riou B. Opioid-related genetic polymorphisms do not influence postoperative opioid requirement: A prospective observational study. Eur J Anaesthesiol. 2018 Jul;35(7):496-504. doi: 10.1097/EJA.0000000000000793.

Reference Type DERIVED
PMID: 29474345 (View on PubMed)

Other Identifiers

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AOR 05038

Identifier Type: -

Identifier Source: org_study_id