Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects

February 6, 2017 updated by: Gianluca Cappelleri, ASST Gaetano Pini-CTO

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Milan, Milano, Italy, 20122
        • Istituto Ortopedico G. Pini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing total knee arthoplasty.

Description

Inclusion Criteria:

  • age > 18
  • ASA I to III

Exclusion Criteria:

  • Contraindications to regional anesthesia procedures
  • Not stabilized neurological diseases
  • Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
VAS<4
VAS>4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of SNPs rs12654788 and rs1042713 of ADBR2 gene in patients who complain persistent pain 4 months postoperatively compared to chronic pain free patients.
Time Frame: 4 months after surgery
4 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Expression frequency of OPRM1, COMT, IL1Ra
Time Frame: 6, 12, 24, 48 hours
6, 12, 24, 48 hours
Serum concentration of TNFα, TGFβ, IFNγ, IL-6 and IL-10 obtained with ELISA system
Time Frame: 6, 12, 24 and 48 hours postoperatively
6, 12, 24 and 48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Gaetano Pini-CTO

Investigators

  • Study Chair: Manuela de Gregori, Biologist, Fondazione IRCCS Policlinico San Matteo di Pavia
  • Study Chair: Massimo Allegri, M.D., Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

February 6, 2017

Study Completion (Actual)

February 6, 2017

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOGPGC03-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe