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Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01989351
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Gianluca Cappelleri, ASST Gaetano Pini-CTO

Brief 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.

Condition or disease
Chronic Pain

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LA PREDISPOSIZIONE AL DOLORE PERSISTENTE POST OPERATORIO IN AMBITO ORTOPEDICO: ASPETTI GENETICI
Study Start Date : March 2013
Actual Primary Completion Date : February 6, 2017
Actual Study Completion Date : February 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort
VAS<4
VAS>4



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Expression frequency of OPRM1, COMT, IL1Ra [ Time Frame: 6, 12, 24, 48 hours ]
  2. Serum concentration of TNFα, TGFβ, IFNγ, IL-6 and IL-10 obtained with ELISA system [ Time Frame: 6, 12, 24 and 48 hours postoperatively ]

Biospecimen Retention:   Samples Without DNA
Blood plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing total knee arthoplasty.
Criteria

Inclusion Criteria:

  • age > 18
  • ASA I to III

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989351


Locations
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Italy
Istituto Ortopedico G. Pini
Milan, Milano, Italy, 20122
Sponsors and Collaborators
ASST Gaetano Pini-CTO
Investigators
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Principal Investigator: Gianluca Cappelleri, MD ASST Gaetano Pini-CTO
Study Chair: Manuela de Gregori, Biologist Policlinico San Matteo Pavia Fondazione IRCCS
Study Chair: Massimo Allegri, M.D. Policlinico San Matteo Pavia Fondazione IRCCS
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Responsible Party: Gianluca Cappelleri, Medical Doctor, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT01989351    
Other Study ID Numbers: IOGPGC03-13
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations