Assessing pain during and after open muscle biopsy for neuromuscular diseases
Exploring Pain: Prospective Observational Study on Pain Perception During and After Muscle Biopsy
This study looks at how much pain people over 18 feel during and after an open muscle biopsy for muscle diseases to help improve pain management for future patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Ile-de-France) |
| Trial ID | NCT06379932 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate pain perception in patients over 18 years old who undergo an open muscle biopsy for suspected myopathic disorders. Participants will complete a self-reported questionnaire assessing pain during and after the procedure, which will help clarify the characteristics of pain associated with muscle biopsy. The study will follow patients for 30 days post-procedure to gather data on their pain experiences and identify factors influencing pain perception. The findings could enhance analgesic management and provide personalized care for future patients undergoing similar procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical suspicion of myopathy requiring an open muscle biopsy.
Not a fit: Patients who do not understand French or are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing muscle biopsies.
How similar studies have performed: While few studies have focused on pain assessment during muscle biopsy, this approach is novel and aims to fill a significant gap in the literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥18 years * Patients with clinical suspicion of myopathy. * Patients requiring open muscle biopsy in the neuropathology unit at GH Pitié Salpêtrière. * Patients who do not object to their participation in the study." Exclusion Criteria: * Patients who do not understand French. * Pregnant women * No social security and patient under AME. * Patient deprived of liberty by court or administrative order, or under legal protection.
Where this trial is running
Paris, Ile-de-France
- Pitié-Salpêtrière — Paris, Ile-de-France, France (Recruiting)
Study contacts
- Principal investigator: Teresinha Maria DIAS EVANGELISTA — Sorbonne University, Pitié salpêtrière hospital
- Study coordinator: Teresinha Maria DIAS EVANGELISTA, MD
- Email: teresinha.evangelista@aphp.fr
- Phone: 0649319165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.