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

Withdrawn

• Conditions: Anesthesia; Surgery
• Interventions: Drug: morphine chlorhydrate

• Registration Number: NCT01233219
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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%).

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	morphine chlorhydrate	Homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene
Group B	morphine chlorhydrate	Both homozygous and heterozygous patients for the less frequent allele of the polymorphism A118G of OPRM1 gene

Primary Outcome Measures

Name	Time	Method
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	first 24 h after surgery	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%).

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of morphine during continuous administration after surgery	48 h after surgery	Pharmacokinetic study of both morphine and its principal active and/or toxic metabolites (M3G and M6G).
Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure	period between 24 - 48 h postsurgery	Frequency of the variants at the loci OPRM1, COMT, UGTs, ESR1, both in patients with NRS ≤4 and in those having NRS \>4 at least once during the period between 24-48 hours postsurgery.
Detection of the possible side effects.	72 h postopratively	Detection of the possible side effects after continuous morphine administration
Detection of the association between M3G/M6G ratio and polymorphisms of UGTs	within 72 h postoperatively	Detection of the association between M3G/M6G ratio and polymorphisms of UGTs and its possible side effects.

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy