Postoperative Pain Trajectories After Endometriosis Surgery

NCT07882498 — Recruiting, 150 participants, Centre Hospitalier Universitaire, Amiens

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Pain Trajectories After Surgery for Endometriosis: A 6-Month Prospective Monocentric Study

RegistryNCT07882498, acronym TRACK-ENDO
StatusRecruiting
Study typeObservational
Enrollment150 (Estimated)
SponsorCentre Hospitalier Universitaire, Amiens (Other)
ConditionsEndometriosis, Postoperative Pain, Pain Trajectories, Chronic Postsurgical Pain, Quantitative Sensory Testing, Central Sensitization
InterventionsPerioperative quantitative sensory testing, questionnaire (Other)
Datesstart 2026-07-07, primary completion 2028-07-01 (estimated), completion 2029-01-01 (estimated), first posted 2026-10-20, last updated 2026-10-20
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Endometriosis All trials for Postoperative Pain All trials of Perioperative quantitative sensory testing All trials of questionnaire

-Summary

The pain associated with endometriosis reflects a multifactorial pathophysiology combining peripheral nociception, central sensitisation and psychosocial factors. Although surgery is an integral part of treatment, a significant proportion of patients experience persistent pain several months after the procedure. To date, postoperative pain trajectories after endometriosis surgery remain poorly characterised, and there are no reliable predictors of chronic postoperative pain (CPP). This prospective, single-centre, longitudinal study aims to identify distinct postoperative pain trajectories and to assess whether perioperative quantitative sensory testing can predict the development of chronic postoperative pain at 3 and 6 months. Patients will undergo perioperative mechanical and pressure tests, including assessment of temporal summation and pressure pain thresholds, combined with validated measures of patient- reported outcomes. Follow-up assessments will be conducted on day 2, day 14, 1 month, 3 months, and 6 months after surgery to capture the dynamic evolution of pain, quality of life, fatigue, sexual function, and central sensitisation symptoms.

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+Arms and interventions

  • Perioperative quantitative sensory testing (Other): Perioperative quantitative sensory testing (mechanical temporal summation and pressure pain thresholds)
  • questionnaire (Other): Repeated administration of validated patient-reported outcome questionnaires

+Outcome measures

Primary outcomes

  • Brief Pain Inventory values for pain intensity and interference measurement [day 2]: Postoperative pain trajectories derived from repeated assessments of pain intensity and interference (Brief Pain Inventory) Brief Pain Inventory (BPI) is a questionnaire with 15 questions. For each question 0 is the smallest score and 10 is the highest score
  • EHP-5 values for quality of life measurement [day 2]: Postoperative pain trajectories derived from quality of life (EHP-5) EHP-5 (Endometriosis health profile 5) is a questionnaire with 10 questions
  • EHP-5 values for quality of life measurement [at 6 months]: Postoperative pain trajectories derived from quality of life (EHP-5) EHP-5 (Endometriosis health profile 5) is a questionnaire with 10 questions
  • FSFI values for sexual function measurement [day 2]: Postoperative pain trajectories derived sexual function (FSFI), Female Sexual Function Index (FSFI) is a questionnaire with 4 questions
  • FSFI values for sexual function measurement [at 6 months]: Postoperative pain trajectories derived sexual function (FSFI), Female Sexual Function Index (FSFI) is a questionnaire with 4 questions
  • Brief Pain Inventory values for pain intensity and interference measurements [at 6 months]: Postoperative pain trajectories derived from repeated assessments of pain intensity and interference (Brief Pain Inventory)
  • PROMIS Fatigue SF-6a values for fatigue measurement [day 2]: Postoperative pain trajectories derived from fatigue (PROMIS Fatigue SF-6a) PROMIS Fatigue SF-6a is a questionnaire with 6 questions
  • PROMIS Fatigue SF-6a values for fatigue measurement [at 6 months]: Postoperative pain trajectories derived from fatigue (PROMIS Fatigue SF-6a) PROMIS Fatigue SF-6a is a questionnaire with 6 questions
  • Convergences PP values for central sensitization symptoms measurement [day 2]: Postoperative pain trajectories derived from and central sensitization symptoms (Convergences PP) Score Convergence PP is a questionnaire with 4 questions
  • Convergences PP values for central sensitization symptoms measurement [at 6 months]: Postoperative pain trajectories derived from and central sensitization symptoms (Convergences PP) Score Convergence PP is a questionnaire with 4 questions

Secondary outcomes

  • Prevalence of chronic postsurgical pain [at 3 months]
  • Prevalence of chronic postsurgical pain [at 6 months]
  • Correlation between pain trajectories and CPSP [at 3 months]
  • Predictive value of perioperative QST parameters [at 3 months]: Predictive value of perioperative QST parameters (preoperative and postoperative day 2) for CPSP
  • Predictive value of perioperative QST parameters [at 6 months]: Predictive value of perioperative QST parameters (preoperative and postoperative day 2) for CPSP

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Age ≥ 18 years
* Imaging-confirmed endometriosis
* Scheduled surgical treatment for endometriosis
* Affiliation to the French Social Security system
* Written informed consent obtained

Exclusion Criteria:

* Patients under legal protection (guardians or curators)
* History of psychiatric disorders
* Neurodegenerative diseases
* Inability to self-assess pain using a numerical rating scale
* Non-French-speaking patients
* Pregnancy or breastfeeding
* Refusal to participate

+Locations (1)

FacilityCityCountryStatus
CHU Amiens-PicardieAmiensFranceRecruiting