NCT01233752

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 224 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Anesthesia
• Surgery

Interventions

Type	Name	Description
DRUG	morphine chlorhydrate	The drug will be administrated by a bolus 45 minutes before the end of the surgery, with the following modalities: bolus with morphine chlorhydrate 0.15 mg/kg ± 20%. Also acetaminophene 1g and ketoprofen 160 mg (ketorolac 30mg) will be administrated during the operation. At the exit of the operative compartment patients will have an electronic pump (PCA) for 48h with morphine chlorhydrate to be used in boluses by 1 mg with a lock out of 5 mins, max dose 20 mg in 4 hours. Moreover, ketoprofen will be prescribed 160 mg x 2 per day (ketorolac 30mg x 2) (in case of allergy acetaminophene 1g x 3 daily). Postoperative analgesic treatment is lasting 48h for each patient (between starting of the PCA infusion (T0) and the following 48h).

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-11-03
• Last updated: 2013-07-19

Locations

2 sites across 1 country: Italy