Chronic PainNCT01989351
Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects
An observational study of Chronic Pain, run by ASST Gaetano Pini-CTO at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to 6 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing total knee arthoplasty.
Who may be able to join
- age > 18
- ASA I to III
Who cannot join
- Contraindications to regional anesthesia procedures
- Not stabilized neurological diseases
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VAS<4 | Not described | |
| VAS>4 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of SNPs rs12654788 and rs1042713 of ADBR2 gene in patients who complain persistent pain 4 months postoperatively compared to chronic pain free patients.
Measured: 4 months after surgery
Secondary outcomes (2)
Expression frequency of OPRM1, COMT, IL1Ra
Measured: 6, 12, 24, 48 hours
Serum concentration of TNFα, TGFβ, IFNγ, IL-6 and IL-10 obtained with ELISA system
Measured: 6, 12, 24 and 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startMar 2013
- Primary completion6 Feb 2017
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Cappelleri, ASST Gaetano Pini-CTO
- Investigators
- Gianluca Cappelleri, MD, Principal investigator, ASST Gaetano Pini-CTOManuela de Gregori, Biologist, Study chair, Fondazione IRCCS Policlinico San Matteo di PaviaMassimo Allegri, M.D., Study chair, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989351
- Sponsor's protocol ID
- IOGPGC03-13
- Status last verified
- Feb 2017
- First submitted
- 5 Nov 2013
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LA PREDISPOSIZIONE AL DOLORE PERSISTENTE POST OPERATORIO IN AMBITO ORTOPEDICO: ASPETTI GENETICI
- ClinicalTrials.gov ID
- NCT01989351
- Acronym / sponsor ID
- IOGPGC03-13
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAS<4 | – | – |
| VAS>4 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total knee arthoplasty.
Key inclusion criteria (2 listed)
- age > 18
- ASA I to III
Key exclusion criteria (3 listed)
- Contraindications to regional anesthesia procedures
- Not stabilized neurological diseases
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Expression frequency of OPRM1, COMT, IL1Ra
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Cappelleri, MD principal investigator
ASST Gaetano Pini-CTO
Manuela de Gregori, Biologist study chair
Fondazione IRCCS Policlinico San Matteo di Pavia
Massimo Allegri, M.D. study chair
Fondazione IRCCS Policlinico San Matteo di Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by ASST Gaetano Pini-CTO at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.