Pharmacokinetic, Pharmacodynamic and Pharmacogenetic of Morphine After Surgery

NCT00822549 | Completed

• 1 other identifier: AOR 05038
• Study Type: observational
• Target: 438
• Locations: 1 country
• Sites: 1

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. 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).

Conditions

Orthopaedic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  during the study

Secondary Outcomes (4)

• - Relationships between morphine consumption, clinical events (efficacy or adverse effects) and morphine (and metabolites) blood concentrations. Immediate postoperative period (PACU)

  Immediate postoperative period (PACU)

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

  Immediate postoperative period (PACU)

• - Relationships between sub-acute clinical events and PK/PG profile. (on the wards at 24 hours after surgery)

  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.

  during the study

Study Arms (1)

1

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

Drug: intravenous morphine titration

Interventions

intravenous morphine titration DRUG

intravenous morphine titration

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing major orthopaedic surgery with severe postoperative pain. All the patients included in the study received intravenous morphine

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital de la Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 29474345 DERIVED

Study Officials

• Frederic Aubrun, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: September 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 11, 2012

Record last verified: 2009-01

Locations

FR (1)