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Completed

NCT Number: NCT00822549

Pharmacokinetic, Pharmacodynamic and Pharmacogenetic of Morphine After Surgery

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).

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Key information

Conditions

Orthopaedic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital de la Pitié Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous morphine titration

Drug

intravenous morphine titration

Primary outcomes

  1. To improve our knowledge on the pharmacodynamic, pharmacokinetic and pharmacogenetic relationships of morphine administered after severe postoperative pain.

    Time frame: during the study

Secondary outcomes

  1. - 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)

  2. - Relationships between clinical events (pain relief, failure in pain relief, adverse effects) and genetic polymorphism.

    Time frame: Immediate postoperative period (PACU)

  3. - 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

  4. To better characterize the age- and sex-related differences which differ between acute and sub-acute periods.

    Time frame: during the study

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Assessment of the Pharmacokinetic, Pharmacodynamic, Pharmacogenetic Relationships of Morphine and Metabolites After Severe Postoperative Pain in Adults

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2009
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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