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

NCT05739747 | Unknown

• 1 other identifier: 02-23-270-003
• Study Type: observational
• Target: 371
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Post Surgical Pain; Cesarean Section Complications; Chronic Pain

Outcome Measures

Primary Outcomes (5)

• 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

• 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.

• 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.

• 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.

• DN4 Questionnaire

  To estimate the probability of neuropathic pain

  Done during physical examination will be performed 3 months after cesarean section.

Study Arms (1)

Women undergoing cesarean section

This study is designed with a single cohort of women who will undergo a scheduled cesarean section

Other: Questionnaire; Other: Questionnaire via telephone call; Other: Physical examination

Interventions

Questionnaire OTHER

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.

Women undergoing cesarean section

Questionnaire via telephone call OTHER

At 3 months, patients will be called and a structured questionnaire will be completed to assess the presence of chronic postoperative pain.

Women undergoing cesarean section

Physical examination OTHER

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.

Women undergoing cesarean section

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective cesarean section.

You may qualify if:

• Patients who underwent elective caesarean section.
• Patients who have previously signed the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Related Publications (11)

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  PMID: 30586070 BACKGROUND

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 31986126 BACKGROUND

• 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.

  PMID: 22337572 BACKGROUND

• 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.

  PMID: 29121211 BACKGROUND

• 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.

  PMID: 28524782 BACKGROUND

• 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.

  PMID: 32541391 BACKGROUND

• 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.

  PMID: 25985024 BACKGROUND

• 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.

  PMID: 14674981 BACKGROUND

• 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.

  PMID: 27756207 BACKGROUND

• 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.

  PMID: 34121077 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 22, 2023
• Study Start: April 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)