NCT01989351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

3.9 years

First QC Date

November 5, 2013

Last Update Submit

February 6, 2017

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (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.

    4 months after surgery

Secondary Outcomes (2)

  • Expression frequency of OPRM1, COMT, IL1Ra

    6, 12, 24, 48 hours

  • Serum concentration of TNFα, TGFβ, IFNγ, IL-6 and IL-10 obtained with ELISA system

    6, 12, 24 and 48 hours postoperatively

Study Arms (2)

VAS<4

VAS>4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing total knee arthoplasty.

You may qualify if:

  • age \> 18
  • ASA I to III

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico G. Pini

Milan, Milano, 20122, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gianluca Cappelleri, MD

    ASST Gaetano Pini-CTO

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 21, 2013

Study Start

March 1, 2013

Primary Completion

February 6, 2017

Study Completion

February 6, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

IT(1)