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NCT01989351 Clinical Trial

Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects

Chronic Pain Clinical Trial

Official title:
LA PREDISPOSIZIONE AL DOLORE PERSISTENTE POST OPERATORIO IN AMBITO ORTOPEDICO: ASPETTI GENETICI

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01989351
Other study ID # IOGPGC03-13
Secondary ID
Status Completed
Phase N/A
First received November 5, 2013
Last updated February 6, 2017
Start date March 2013
Est. completion date February 6, 2017

Study information
Verified date February 2017
Source ASST Gaetano Pini-CTO
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study purpose is to examine polymorphism of genes associated to post-operative persistent pain and to verify the possible association between genotype phenotype and ADRB2 polymorphism in orthopaedic surgery. The primary aim is to evaluate the expression of ADBR2 in VAS>4 patients and to compare it to those with VAS<4.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date February 6, 2017
Est. primary completion date February 6, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age > 18

- ASA I to III

Exclusion Criteria:

- Contraindications to regional anesthesia procedures

- Not stabilized neurological diseases

- Diabetes

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Istituto Ortopedico G. Pini Milan Milano

Sponsors (1)
Lead Sponsor Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of SNPs rs12654788 and rs1042713 of ADBR2 gene in patients who complain persistent pain 4 months postoperatively compared to chronic pain free patients. 4 months after surgery
Secondary Expression frequency of OPRM1, COMT, IL1Ra 6, 12, 24, 48 hours
Secondary Serum concentration of TNFa, TGFß, IFN?, IL-6 and IL-10 obtained with ELISA system 6, 12, 24 and 48 hours postoperatively
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