Clinical trial NCT01233219: Association Between Clinical Effect of Continuous Morphine Administration After Surgery and Pharmacogenetics
Official title: Association Between Clinical Effect of Continuous Morphine Administration in Patients After Major Surgery and Pharmacogenetics: Perspective Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Anesthesia
Surgery
Keywords: systemic morphine analgesia
pharmacogenetics
pharmacokinetics
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pazients scheduled for major abdominal or urological surgery with postoperative pain control with continuous morphine administration

Brief 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.

Detailed 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%).

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the rescue doses 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
timeFrame: first 24 h after surgery
Secondary outcomes:
measure: Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
timeFrame: during 24 h postsurgery
measure: Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
timeFrame: period between 24 - 48 h postsurgery
measure: Pharmacokinetics of morphine during continuous administration after surgery
timeFrame: 48 h after surgery
measure: Detection of the possible side effects.
timeFrame: 72 h postopratively
measure: Detection of the association between M3G/M6G ratio and polymorphisms of UGTs
timeFrame: within 72 h postoperatively
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: IRCCS Policlinico San Matteo
name: Massimo Allegri, MD
role: PRINCIPAL_INVESTIGATOR
References: