Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section

Chronic Pain Clinical Trial

Official title:

Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739747
• Other study ID #: 02-23-270-003
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 371
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent elective caesarean section.

• Patients who have previously signed the informed consent form.

Exclusion Criteria

• 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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Chronic Pain
• Chronic Post Surgical Pain
• Pain, Postoperative

Intervention

Other:
• Questionnaire
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.
• Questionnaire
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
• Questionnaire
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 call
At 3 months, patients will be called and a structured questionnaire will be completed to assess the presence of chronic postoperative pain.
• Physical examination
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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Althaus 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. — View Citation

Jin 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. — View Citation

Kehlet 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. — View Citation

Mathes 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. — View Citation

Meretoja 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. — View Citation

Montes 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. — View Citation

Montes 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. — View Citation

Nikolajsen 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. — View Citation

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. — View Citation

Sharma 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. — View Citation

Stuart 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gendolcat score	The Gendolcat score assesses the likelihood of suffering chronic post-surgical pain	The Gendolcat score will be assessed on the day patients are included in the study
Primary	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.	Done during physical examination will be performed 3 months after cesarean section.
Primary	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	Done during physical examination will be performed 3 months after cesarean section.
Primary	Short Edition of the Brief Pain Inventory	Rapidly assesses the severity of pain and its impact on functioning	Done during physical examination will be performed 3 months after cesarean section.
Primary	DN4 Questionnaire	To estimate the probability of neuropathic pain	Done during physical examination will be performed 3 months after cesarean section.