Chronic Postoperative PainNCT02991287
Validation of Predictive Scale of Chronic Postsurgical Pain
An observational study of Chronic Postoperative Pain, run by Parc de Salut Mar at 21 sites in Spain.
Trial summary
To asses the precision of a score to predict chronic post surgical pain in patients undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy. Prospective multicenter cohort study in 21 hospital in spain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Postoperative Pain
- What is being tested?
- Inguinal hernia repair, Abdominal hysterectomy and Vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,040 participants
- Where
- 21 sitesSpain
- Study dates
- Feb 2017to Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All spanish patients who undergo scheduled surgery of one of the following types: inguinal herniorrhaphy, abdominal hysterectomy, vaginal hysterectomy, thoracotomy.
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), abdominal hysterectomy, vaginal hysterectomy and thoracotomy (men)
Who cannot join
- Patients aged less than 18 years,
- Patients requiring reoperation because of surgical complications.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Hospital General de Alicante
Alicante, Valencia, 03010
Ana Peiró, PhD, 0034605861967, peiro.anamaria@gmail.com
Hospital de Badalona
Badalona, Barcelona, 08911
Dolors Sintes, PhD, 0034934648447, dsintes@bsa.cat
Hospital Germans Tries i Pujol
Badalona, Barcelona, 08916
Gisela Roca, PhD, 0034639111869
giselaroca@gmail.com
Hospital de Cruces
Barakaldo, Bizcaia, 48903
Alberto Martínez, PhD, 0034946006000, alberto.martinezruiz@osakidetza.eus
Hospital del Mar
Barcelona, Barcelona, 08003
Antonio Montes, PhD, 0034932483350, AMontes@parcdesalutmar.cat
Hospital de Sant Pau
Barcelona, Barcelona, 08026
Miren Revuelta, PhD, 0034935565836, mrevuelta@santpau.cat
Hospital de la Vall d'Hebrón
Barcelona, Barcelona, 08035
Angela Mesas, PhD, 0034649483472, amesas@vhebron.net
Hospital de Sant Rafael
Barcelona, Barcelona, 08035
José Luís Casbas, PhD, 0034932112508, jlcasbas.hsrafael@hospitalarias.es
Hospital de Galdakao
Bizkaia, Bizkaia, 48960
Sonia Latorre Esteban, PhD, 0034675711390, sonia.latorreesteban@osakidetza.eus
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Ancor Serrano, PhD, 00342607323, a.serrano@bellvitgehospital.cat
Hopsital Gregorio Marañon
Madrid, Madrid, 28007
Carmen Benito Alcala, PhD, 0034638210787, mbeniro.hgugm@salud.madrid.org
Hospital 12 de Octubre
Madrid, Madrid, 28041
Raquel Saldaña Casado, PhD, 0034629768968, rasalca@gmail.com
Hospital de Mataró
Mataró, Barcelona, 08304
Paloma Ricós, PhD, 0034629957578, paloma.ricos@gmail.com
Hospital Son Espases
Palma de Mallorca, Palma, 07120
Hermann Ribera, PhD, 0034652688385, h.ribera@hotmail.com
Hospital Son Llatzer
Palma de Mallorca, Palma, 07198
Jose Luis Aguilar, PhD, 0034670058182, 15049jas@gmail.com
Hospital Parc Taulí
Sabadell, Barcelona, 08208
Josep Troy, PhD, 0034649954375, morphicman@gmail.com
Hospital Nuestra Señora de Valme
Seville, Sevilla, 41014
Fernando Caba Rabientos, PhD, 0034955 01 50 00, fcababarrientos@terra.com
Hospital de Terrassa
Terrassa, Barcelona, 08227
Carmen Martin Pardo, PhD, 0034655696311, cmartin@cst.cat
Hospital Universitario La Fe
Valencia, Valencia, 46026
Javier Dese, PhD, 0034625471540, javierdese@hotmail.com
Hospital Lluís Alcanyís de Xàtiva
Valencia, Valencia, 46800
Vicente Domingo, PhD, 0034610550892, domingo_vic@gva.es
Hospital de Valladolid
Valladolid, Valladolid, 47003
Maria Asunción Pérez Herrero, PhD, 0034630750263, aperezh@saludcastillayleon.es
About this study
Official title: Prospective External Validation of a Predictive Scale of Chronic Postsurgical Pain
To asses the precision of a score to predict chronic post surgical pain in patients undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.
- Conditions
- Chronic Postoperative Pain
- Being tested
- Inguinal hernia repair, Abdominal hysterectomy, Vaginal hysterectomy, Thoracotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal hernia repairProcedure or surgery
Abdominal hysterectomyProcedure or surgery
Vaginal hysterectomyProcedure or surgery
ThoracotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Chronic post-surgical pain patients | Patients scheduled for differents types of surgery (inguinal, hernia repair, abdominal hysterectomy, vaginal hysterectomy, and thoracotomy). Receives: Procedure: Inguinal hernia repair; Procedure: Abdominal hysterectomy; Procedure: Vaginal hysterectomy; Procedure: Thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12).
GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12) to identify patients that could develop chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy.
Measured: After evaluation of chronic postsurgical pain 4th month after the end of surgery
Secondary outcomes (1)
Verbal rating scale
Prevalence of chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy will be assessed by verbal rating scale.
Measured: After evaluation of chronic postsurgical pain 4th month after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startFeb 2017
- Primary completionFeb 2019 (estimated)
- Study completionDec 2019 (estimated)
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
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Montes, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991287
- Sponsor's protocol ID
- PI16/00279
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Roca G, Sabate S, Serrano A, Benito MC, Perez M, Revuelta M, Lorenzo A, Busquets J, Rodriguez G, Sanz D, Jimenez A, Parera A, de la Gala F, Montes A. Sex Differences in Chronic Postsurgical Pain after Open Thoracotomy. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3134-3142. doi: 10.1053/j.jvca.2024.08.039. Epub 2024 Sep 4.
PubMed 39322441Montes A, Roca G, Cantillo J, Sabate S; GENDOLCAT Study Group. Presurgical risk model for chronic postsurgical pain based on 6 clinical predictors: a prospective external validation. Pain. 2020 Nov;161(11):2611-2618. doi: 10.1097/j.pain.0000000000001945.
PubMed 32541391
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective External Validation of a Predictive Scale of Chronic Postsurgical Pain
- ClinicalTrials.gov ID
- NCT02991287
- Acronym / sponsor ID
- PI16/00279
- Conditions
- Chronic Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Dec 2016 (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.
To asses the precision of a score to predict chronic post surgical pain in patients undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic post-surgical pain patients | – | Procedure: Inguinal hernia repair, Procedure: Abdominal hysterectomy, Procedure: Vaginal hysterectomy, Procedure: ThoracotomyPatients scheduled for differents types of surgery (inguinal, hernia repair, abdominal hysterectomy, vaginal hysterectomy, and thoracotomy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All spanish patients who undergo scheduled surgery of one of the following types: inguinal herniorrhaphy, abdominal hysterectomy, vaginal hysterectomy, thoracotomy.
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), abdominal hysterectomy, vaginal hysterectomy and 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 hernia repair | Procedure or surgery | Chronic post-surgical pain patients |
| Abdominal hysterectomy | Procedure or surgery | Chronic post-surgical pain patients |
| Vaginal hysterectomy | Procedure or surgery | Chronic post-surgical pain patients |
| Thoracotomy | Procedure or surgery | Chronic post-surgical pain patients |
Primary outcome
GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12).
Time frame: After evaluation of chronic postsurgical pain 4th month after the end of surgery
GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12) to identify patients that could develop chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy.
1 secondary outcome
Verbal rating scale
Time frame: After evaluation of chronic postsurgical pain 4th month after the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Derived from this study: PubMed 39322441Roca G, Sabate S, Serrano A, Benito MC, Perez M, Revuelta M, Lorenzo A, Busquets J, Rodriguez G, Sanz D, Jimenez A, Parera A, de la Gala F, Montes A. Sex Differences in Chronic Postsurgical Pain after Open Thoracotomy. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3134-3142. doi: 10.1053/j.jvca.2024.08.039. Epub 2024 Sep 4.
- Derived from this study: PubMed 32541391Montes A, Roca G, Cantillo J, Sabate S; GENDOLCAT Study Group. Presurgical risk model for chronic postsurgical pain based on 6 clinical predictors: a prospective external validation. Pain. 2020 Nov;161(11):2611-2618. doi: 10.1097/j.pain.0000000000001945.
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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.
21 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 Parc de Salut Mar at 21 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Montes, PhD (0034932483000, amontes@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12). (time frame: After evaluation of chronic postsurgical pain 4th month after the end 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 NCT02991287, 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 13 Dec 2016.