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Association Between Clinical Effect of Morphine With PCA After Surgery and Pharmacogenetics

Information source: IRCCS Policlinico S. Matteo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia; Surgery

Intervention: morphine chlorhydrate (Drug)

Phase: N/A

Status: Completed

Sponsored by: IRCCS Policlinico S. Matteo

Official(s) and/or principal investigator(s):
Massimo Allegri, MD, Principal Investigator, Affiliation: IRCCS Policlinico San Matteo

Summary

Identification of the genetic polymorphisms that could be correlated either with a better clinical response or with a major predisposition of patients to develop tolerance and/or side effects to the treatment with morphine.

Clinical Details

Official title: Association Between Clinical Effect of Morphine in Patients With PCA After Major Surgery and Pharmacogenetics: Prospective Observational Clinical Study.

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Assessment of the medium morphine dose (mg/kg/die)in the two groups homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene; group B: both homozygous and heterozygous patients for the less frequent allele

Secondary outcome:

Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure

Detection of the medium morphine dose

Pharmacokinetics of morphine with PCA after surgery

Variants frequency at loci OPRM1, COMT, UGTs, ESR1

Detection of the possible side effects.

Detection of the association between M3G/M6G ratio and polymorphisms of UGTs (and possible side effects).

Detailed description: Valuation of the medium morphine dose (mg/kg/die) necessary to maintain NRS<4 in the first 24 hours post-surgery in the two groups of patients, A e B. Group A: homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene (about 80%); group B: both homozygous and heterozygous patients for the less frequent allele (about 20%). In order to avoid the bias related to alterations in metabolism, patients with Cmax and AUC of morphine (and metabolites M6G and M3G) >2 standard deviation higher than expected population curve ("outliers") will be excluded for the primary purpose.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Males and females over 18 years, under 75 years, scheduled for postoperative pain

control by PCA morphine administration

- HIV negative

- Classification American Society of Anesthesiologists (ASA) I: without systemic

disease

- Classification ASA II or III (mild systemic disease or severe systemic disease that

limits the activity without invalidity).

- Undergoing abdominal and urologic major surgery (neither urgent nor emergency

surgery)

- Signed informed consent

Exclusion criteria:

- Usual assumption of analgesic opioids

- Cognitive alterations nor mental retardation

- Severe hepatic/renal insufficiency (cholinesterase <3000 mU/ml, total bilirubinaemia

<2 mg/dl and creatininaemia <1. 2 mg/dl)

- Inpatients in intensive therapy, either with sedation and/or mechanic ventilation.

- Allergies to morphine and derivates

Locations and Contacts

Azienda Ospedaliera San Gerardo, Monza 20052, Italy

Fondazione IRCCS Policlinico San Matteo, Pavia 27100, Italy

Additional Information

Starting date: July 2010
Last updated: July 18, 2013

Page last updated: August 23, 2015

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