Chronic Postoperative PainNCT01510496
Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy: Analysis of Risk Factors and Association With Genetic Polymorphisms
An observational study of Chronic Postoperative Pain, run by Fundacion IMIM at 26 sites in Spain.
Trial summary
The treatment of postoperative pain continues to be inadequate in the investigators practice setting. Inadequate pain treatment not only contributes to postoperative complications in the short term but can also be a factor that favors the development of chronic postoperative pain and diminishes long-term quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Postoperative Pain
- What is being tested?
- Inguinal herniorraphy., Hysterectomy. and Thoracotomy .
- Type of treatment
- Surgery or procedure
- How many people
- 3,979 participants
- Where
- 26 sitesSpain
- Study dates
- Jan 2009to Jul 2014
- 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: All spanish patients who undergo scheduled surgery of one of the following types: inguinal herniorrhaphy, hysterectomy, toracothomy.
Who may be able to join
- Patients with given inform consent, aged mor than 18 years, who undergo scheduled surgery of one of the following types: inguinal hernia (men), hysterectomy, thoracotomy (men).
Who cannot join
- Patients aged less than 18 years,
- Patients requiring reoperation because of surgical complications.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Spain26 sites
Hospital Municipal de Badalona
Badalona, Barcelona, 08911
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital de l'Esperança
Barcelona, Barcelona, 08024
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital Sagrat Cor
Barcelona, Barcelona, 08029
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Hospital del Sant Boi
Barcelona, Barcelona, 08830
Hospital de San Bernabé
Berga, Barcelona, 08600
Hospital Universitari Doctor Josep Trueta de Girona
Girona, Girona, 17007
Hospital de Granollers
Granollers, Barcelona, 08400
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Santa Maria
Lleida, Lleida, 25198
Hospital General de Manresa
Manresa, Barcelona, 08240
Hospital de Mataro
Mataró, Barcelona, 08304
Hospital Sant Joan de Reus
Reus, Tarragona, 43201
Hospital Parc Tauli
Sabadell, Barcelona, 08208
Hospital de Santa Caterina
Salt, Girona, 17190
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221
Hospital Universitari Mutua de Terrassa
Terrassa, Barcelona, 08227
Hospital Clínico de Valencia
Valencia, Valencia, 46010
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Hospital Universitari de la Fe
Valencia, Valencia, 46026
Hospital de Viladecans
Viladecans, Barcelona, 08840
Hospital Lluís Alcanyís de Xàtiva
Xàtiva, València, 46800
About this study
Official title: Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy : Analysis of Risk Factors and Association With Genetic Polymorphisms
The treatment of postoperative pain continues to be inadequate in the investigators practice setting.
Inadequate pain treatment not only contributes to postoperative complications in the short term but can also be a factor that favors the development of chronic postoperative pain and diminishes long-term quality of life. Risk factors that can lead to a transition to chronic pain need to be analyzed.
- Conditions
- Chronic Postoperative Pain
- Being tested
- Inguinal herniorraphy., Hysterectomy., Thoracotomy .
- Keywords
- Chronic pain, genetic polymorphisms, postoperative pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal herniorraphy.Procedure or surgery
Inguinal herniorraphy (non laparoscopic).
Hysterectomy.Procedure or surgery
Hysterectomy: Vaginal and abdominal.
Thoracotomy .Procedure or surgery
Thoracotomy (non laparoscopic).
| Study group | Role | What they receive |
|---|---|---|
| Patients who had inguinal herniorraphy. | Not described Receives: Procedure: Inguinal herniorraphy. | |
| Patients who had hysterectomy. | Not described Receives: Procedure: Hysterectomy. | |
| Patients who had thoracotomy. | Not described Receives: Procedure: Thoracotomy . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of chronic postsurgical pain.
After 3 months a physical examination will take place and after 12 months a follow-up will be reported by phone.
Measured: After 3 and 12 months of surgery.
Secondary outcomes (1)
Predictive factors of chronic postsurgical pain.
Preoperative (psychological factors, preoperative pain, pharmacologic treatment) intraoperative (surgical technic, type of anaestesia) and postoperative(posoperative pain, surgical complications and treatment of postoperative pain).
Measured: After 3 and 12 months of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Postoperative 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
- 3,979 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion IMIM
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Montes, Fundacion IMIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510496
- Sponsor's protocol ID
- GENDOLCAT
- Status last verified
- Dec 2015
- First submitted
- 23 Dec 2011
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bande D, Molto L, Pereira JA, Montes A. Chronic pain after groin hernia repair: pain characteristics and impact on quality of life. BMC Surg. 2020 Jul 6;20(1):147. doi: 10.1186/s12893-020-00805-9.
PubMed 32631293Montes A, Roca G, Sabate S, Lao JI, Navarro A, Cantillo J, Canet J; GENDOLCAT Study Group. Genetic and Clinical Factors Associated with Chronic Postsurgical Pain after Hernia Repair, Hysterectomy, and Thoracotomy: A Two-year Multicenter Cohort Study. Anesthesiology. 2015 May;122(5):1123-41. doi: 10.1097/ALN.0000000000000611.
PubMed 25985024
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy : Analysis of Risk Factors and Association With Genetic Polymorphisms
- ClinicalTrials.gov ID
- NCT01510496
- Acronym / sponsor ID
- GENDOLCAT
- Conditions
- Chronic Postoperative Pain
- Keywords
- Chronic pain, genetic polymorphisms, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,979 participants (actual)
- Lead sponsor
- Fundacion IMIMUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Jan 2012 (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 treatment of postoperative pain continues to be inadequate in the investigators practice setting.
Inadequate pain treatment not only contributes to postoperative complications in the short term but can also be a factor that favors the development of chronic postoperative pain and diminishes long-term quality of life. Risk factors that can lead to a transition to chronic pain need to be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients who had inguinal herniorraphy. | – | Procedure: Inguinal herniorraphy. |
| Patients who had hysterectomy. | – | Procedure: Hysterectomy. |
| Patients who had thoracotomy. | – | Procedure: Thoracotomy . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All spanish patients who undergo scheduled surgery of one of the following types: inguinal herniorrhaphy, hysterectomy, toracothomy.
Key inclusion criteria (1 listed)
- Patients with given inform consent, aged mor than 18 years, who undergo scheduled surgery of one of the following types: inguinal hernia (men), hysterectomy, thoracotomy (men).
Key exclusion criteria (2 listed)
- Patients aged less than 18 years,
- Patients requiring reoperation because of surgical complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inguinal herniorraphy.Inguinal herniorraphy (non laparoscopic). | Procedure or surgery | Patients who had inguinal herniorraphy. |
| Hysterectomy.Hysterectomy: Vaginal and abdominal. | Procedure or surgery | Patients who had hysterectomy. |
| Thoracotomy .Thoracotomy (non laparoscopic). | Procedure or surgery | Patients who had thoracotomy. |
Primary outcome
Evaluation of chronic postsurgical pain.
Time frame: After 3 and 12 months of surgery.
After 3 months a physical examination will take place and after 12 months a follow-up will be reported by phone.
1 secondary outcome
Predictive factors of chronic postsurgical pain.
Time frame: After 3 and 12 months of surgery.
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 30 Dec 2015.
- Derived from this study: PubMed 32631293Bande D, Molto L, Pereira JA, Montes A. Chronic pain after groin hernia repair: pain characteristics and impact on quality of life. BMC Surg. 2020 Jul 6;20(1):147. doi: 10.1186/s12893-020-00805-9.
- Derived from this study: PubMed 25985024Montes A, Roca G, Sabate S, Lao JI, Navarro A, Cantillo J, Canet J; GENDOLCAT Study Group. Genetic and Clinical Factors Associated with Chronic Postsurgical Pain after Hernia Repair, Hysterectomy, and Thoracotomy: A Two-year Multicenter Cohort Study. Anesthesiology. 2015 May;122(5):1123-41. doi: 10.1097/ALN.0000000000000611.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Postoperative Pain, run by Fundacion IMIM at 26 sites in Spain.
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 1 inclusion and 2 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 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Spain. 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?
Evaluation of chronic postsurgical pain. (time frame: After 3 and 12 months of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510496, which also lists 2 linked publications.
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 30 Dec 2015.