Chronic Post Surgical PainNCT05739747
Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section
An observational study of Chronic Post Surgical Pain and Cesarean Section Complications, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
Chronic post-surgical pain is a problem that has historically been underestimated. Over the last few years there has been a search for strategies to both predict and prevent its occurrence in patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Post Surgical Pain, Cesarean Section Complications, Chronic Pain
- What is being tested?
- Questionnaire, Questionnaire via telephone call and Physical examination
- How many people
- 371 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to Feb 2025
- How long will I take part?
- 3 Months
- 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
- Women only
- Adult, Older adult
Study population: Patients undergoing elective cesarean section.
Who may be able to join
- Patients who underwent elective caesarean section.
- Patients who have previously signed the informed consent form.
Who cannot join
- Urgent cesarean section.
- Patients with severe psychiatric pathology.
- Patients who require a different surgical approach than usual.
- Patients who refuse to take part in the study and/or to sign the informed consent form.
- informed consent.
- Patients with a high language barrier.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Carles Espinós Ramírez, 650125113, md071683@uic.es
About this study
Official title: Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section.
Chronic post-surgical pain is a problem that has historically been underestimated. Over the last few years there has been a search for strategies to both predict and prevent its occurrence in patients undergoing surgery. The Gendolcat index is the only predictive model that uses only objective pre-surgical variables to assess the risk of suffering chronic post-surgical pain. However, it is only validated for the following surgeries: thoracotomy, hysterectomy and open inguinal hernia. Our aim is to test whether the Gendolcat model is also valid for cesarean section.
- Being tested
- Questionnaire, Questionnaire via telephone call, Physical examination
- 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.
QuestionnaireOther
All patients should complete the following questionnaires:
On the day of surgery:
- Patient registration.
- Complete medical history.
- Gendolcat scale (including the Spanish version of the SF-12 scale).
- Spanish version of the catastrophizing scale.
QuestionnaireOther
The investigators should complete a questionnaire during the surgical procedure specifying the anesthetic technique used, drugs and doses used and record any incident during the surgical procedure
QuestionnaireOther
The investigators should complete a questionnaire 24 hours after surgery to assess the possible presence of postoperative pain as well as the intensity and need for rescue analgesia.
Questionnaire via telephone callOther
At 3 months, patients will be called and a structured questionnaire will be completed to assess the presence of chronic postoperative pain.
Physical examinationOther
Those women who, after the telephone call, are considered to have chronic post-surgical pain will undergo a physical examination to confirm it. The type of pain and its intensity will also be evaluated. The impact on their daily physical activity and quality of life will be evaluated by means of a questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing cesarean section | This study is designed with a single cohort of women who will undergo a scheduled cesarean section Receives: Other: Questionnaire; Other: Questionnaire via telephone call; Other: Physical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gendolcat score
The Gendolcat score assesses the likelihood of suffering chronic post-surgical pain
Measured: The Gendolcat score will be assessed on the day patients are included in the study
Categoric Pain Scale
These pain scales give people a simple way to rate their pain intensity using a verbal or visual descriptor of their pain.
Measured: Done during physical examination will be performed 3 months after cesarean section.
Numeric Pain Scale
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity
Measured: Done during physical examination will be performed 3 months after cesarean section.
Short Edition of the Brief Pain Inventory
Rapidly assesses the severity of pain and its impact on functioning
Measured: Done during physical examination will be performed 3 months after cesarean section.
DN4 Questionnaire
To estimate the probability of neuropathic pain
Measured: Done during physical examination will be performed 3 months after cesarean section.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Apr 2023
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Post Surgical 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
- 371 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carles Espinos Ramírez, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739747
- Sponsor's protocol ID
- 02-23-270-003
- Status last verified
- Jul 2023
- First submitted
- 5 Feb 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
PubMed 30586070Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Stuart AR, Kuck K, Naik BI, Saager L, Pace NL, Domino KB, Posner KL, Alpert SB, Kheterpal S, Sinha AK, Brummett CM, Durieux ME; the MPOG EOS Investigator Group. Multicenter Perioperative Outcomes Group Enhanced Observation Study Postoperative Pain Profiles, Analgesic Use, and Transition to Chronic Pain and Excessive and Prolonged Opioid Use Patterns Methodology. Anesth Analg. 2020 Jun;130(6):1702-1708. doi: 10.1213/ANE.0000000000004568.
PubMed 31986126Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
PubMed 22337572Mathes T, Pape-Kohler C, Moerders L, Lux E, Neugebauer EAM. External Validation and Update of the RICP-A Multivariate Model to Predict Chronic Postoperative Pain. Pain Med. 2018 Aug 1;19(8):1674-1682. doi: 10.1093/pm/pnx242.
PubMed 29121211Meretoja TJ, Andersen KG, Bruce J, Haasio L, Sipila R, Scott NW, Ripatti S, Kehlet H, Kalso E. Clinical Prediction Model and Tool for Assessing Risk of Persistent Pain After Breast Cancer Surgery. J Clin Oncol. 2017 May 20;35(15):1660-1667. doi: 10.1200/JCO.2016.70.3413. Epub 2017 Mar 13.
PubMed 28524782Montes 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 32541391Montes 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 25985024Nikolajsen L, Sorensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. doi: 10.1111/j.1399-6576.2004.00271.x.
PubMed 14674981Jin J, Peng L, Chen Q, Zhang D, Ren L, Qin P, Min S. Prevalence and risk factors for chronic pain following cesarean section: a prospective study. BMC Anesthesiol. 2016 Oct 18;16(1):99. doi: 10.1186/s12871-016-0270-6.
PubMed 27756207Sharma LR, Schaldemose EL, Alaverdyan H, Nikolajsen L, Chen D, Bhanvadia S, Komen H, Yaeger L, Haroutounian S. Perioperative factors associated with persistent postsurgical pain after hysterectomy, cesarean section, prostatectomy, and donor nephrectomy: a systematic review and meta-analysis. Pain. 2022 Mar 1;163(3):425-435. doi: 10.1097/j.pain.0000000000002361.
PubMed 34121077
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section.
- ClinicalTrials.gov ID
- NCT05739747
- Acronym / sponsor ID
- 02-23-270-003
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 371 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 22 Feb 2023 (actual)
- 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.
Chronic post-surgical pain is a problem that has historically been underestimated. Over the last few years there has been a search for strategies to both predict and prevent its occurrence in patients undergoing surgery. The Gendolcat index is the only predictive model that uses only objective pre-surgical variables to assess the risk of suffering chronic post-surgical pain. However, it is only validated for the following surgeries: thoracotomy, hysterectomy and open inguinal hernia. Our aim is to test whether the Gendolcat model is also valid for cesarean section.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing cesarean section | – | Other: Questionnaire, Other: Questionnaire via telephone call, Other: Physical examinationThis study is designed with a single cohort of women who will undergo a scheduled cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cesarean section.
Key inclusion criteria (2 listed)
- Patients who underwent elective caesarean section.
- Patients who have previously signed the informed consent form.
Key exclusion criteria (6 listed)
- Urgent cesarean section.
- Patients with severe psychiatric pathology.
- Patients who require a different surgical approach than usual.
- Patients who refuse to take part in the study and/or to sign the informed consent form.
- informed consent.
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 |
|---|---|---|
| QuestionnaireAll patients should complete the following questionnaires: On the day of surgery: * Patient registration. * Complete medical history. * Gendolcat scale (including the Spanish version of the SF-12 scale). * Spanish version of the catastrophizing scale. | Other | Women undergoing cesarean section |
| QuestionnaireThe investigators should complete a questionnaire during the surgical procedure specifying the anesthetic technique used, drugs and doses used and record any incident during the surgical procedure | Other | Women undergoing cesarean section |
| QuestionnaireThe investigators should complete a questionnaire 24 hours after surgery to assess the possible presence of postoperative pain as well as the intensity and need for rescue analgesia. | Other | Women undergoing cesarean section |
| Questionnaire via telephone callAt 3 months, patients will be called and a structured questionnaire will be completed to assess the presence of chronic postoperative pain. | Other | Women undergoing cesarean section |
| Physical examinationThose women who, after the telephone call, are considered to have chronic post-surgical pain will undergo a physical examination to confirm it. The type of pain and its intensity will also be evaluated. The impact on their daily physical activity and quality of life will be evaluated by means of a questionnaire. | Other | Women undergoing cesarean section |
Primary outcome
Gendolcat score
Time frame: The Gendolcat score will be assessed on the day patients are included in the study
The Gendolcat score assesses the likelihood of suffering chronic post-surgical pain
Categoric Pain Scale
Time frame: Done during physical examination will be performed 3 months after cesarean section.
These pain scales give people a simple way to rate their pain intensity using a verbal or visual descriptor of their pain.
Numeric Pain Scale
Time frame: Done during physical examination will be performed 3 months after cesarean section.
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity
Short Edition of the Brief Pain Inventory
Time frame: Done during physical examination will be performed 3 months after cesarean section.
Rapidly assesses the severity of pain and its impact on functioning
DN4 Questionnaire
Time frame: Done during physical examination will be performed 3 months after cesarean section.
To estimate the probability of neuropathic pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Background: PubMed 30586070Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Background: PubMed 31986126Stuart AR, Kuck K, Naik BI, Saager L, Pace NL, Domino KB, Posner KL, Alpert SB, Kheterpal S, Sinha AK, Brummett CM, Durieux ME; the MPOG EOS Investigator Group. Multicenter Perioperative Outcomes Group Enhanced Observation Study Postoperative Pain Profiles, Analgesic Use, and Transition to Chronic Pain and Excessive and Prolonged Opioid Use Patterns Methodology. Anesth Analg. 2020 Jun;130(6):1702-1708. doi: 10.1213/ANE.0000000000004568.
- Background: PubMed 22337572Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
- Background: PubMed 29121211Mathes T, Pape-Kohler C, Moerders L, Lux E, Neugebauer EAM. External Validation and Update of the RICP-A Multivariate Model to Predict Chronic Postoperative Pain. Pain Med. 2018 Aug 1;19(8):1674-1682. doi: 10.1093/pm/pnx242.
- Background: PubMed 28524782Meretoja TJ, Andersen KG, Bruce J, Haasio L, Sipila R, Scott NW, Ripatti S, Kehlet H, Kalso E. Clinical Prediction Model and Tool for Assessing Risk of Persistent Pain After Breast Cancer Surgery. J Clin Oncol. 2017 May 20;35(15):1660-1667. doi: 10.1200/JCO.2016.70.3413. Epub 2017 Mar 13.
- Background: 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.
- Background: 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.
- Background: PubMed 14674981Nikolajsen L, Sorensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. doi: 10.1111/j.1399-6576.2004.00271.x.
- Background: PubMed 27756207Jin J, Peng L, Chen Q, Zhang D, Ren L, Qin P, Min S. Prevalence and risk factors for chronic pain following cesarean section: a prospective study. BMC Anesthesiol. 2016 Oct 18;16(1):99. doi: 10.1186/s12871-016-0270-6.
- Background: PubMed 34121077Sharma LR, Schaldemose EL, Alaverdyan H, Nikolajsen L, Chen D, Bhanvadia S, Komen H, Yaeger L, Haroutounian S. Perioperative factors associated with persistent postsurgical pain after hysterectomy, cesarean section, prostatectomy, and donor nephrectomy: a systematic review and meta-analysis. Pain. 2022 Mar 1;163(3):425-435. doi: 10.1097/j.pain.0000000000002361.
- Individual participant dataSharing planned: No
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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.
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 Post Surgical Pain and Cesarean Section Complications, run by Consorci Sanitari de Terrassa at 1 site 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 2 inclusion and 6 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 25 Jul 2023. 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gendolcat score (time frame: The Gendolcat score will be assessed on the day patients are included in the study). The study lists 5 primary outcomes in all. 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 NCT05739747, which also lists 11 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 25 Jul 2023.