Association Between Clinical Effect of Continuous Morphine Administration After Surgery and Pharmacogenetics

IRCCS Policlinico S. Matteo

Status

Withdrawn

Conditions

Surgery

Anesthesia

Treatments

Drug: morphine chlorhydrate

Study type

Observational

Funder types

Other

Identifiers

NCT01233219

PT-SM-08-MorfinaContinua-Gene

Details and patient eligibility

About

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.

Full description

Valuation of the rescue doses 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%).

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females over 18 years, under 75 years, scheduled for postoperative pain control with continuous 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