Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain

Surgery Clinical Trial

Official title:

Role of Genetic, Neurophysiological and Psychological Factors in the Development of Postsurgical Neuropathic Pain After Breast Surgery for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368275
• Other study ID #: Predictive cohort
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2021
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of these cohorts is to detect potential genetic, neurophysiological psychological and cognitive risk factors for the development of chronic postsurgical pain including neuropathic pain.

Description:

This new study will enroll patients undergoing mastectomy or thoracotomy for cancer. They will be three cohorts :

• one prospective cohort constituted of women undergoing breast surgery in René Huguenin Hospital (Saint Cloud) and followed for up to one year after surgery.

• another cross sectional cohort constituted of patient association (Seintinelle) including women operated up to 2 years previously from breast surgery.

• One prospective cohort constituted of women or men undergoing thoracotomy in Foch hospital (Suresnes) and followed for up to one year after surgery.

The main objectives of these cohorts will be to detect potential genetic, neurophysiological, psychological and cognitive risk factors for the development of chronic postsurgical neuropathic pain.

These patients will questioned about demographics, age, sex, body mass index. A large neuropsychological and psychological battery of tests will be conducted. Sensory function will assessed using quantitative sensory testing. Biological samples will analyse potential genetic factors in the development of neuropathic pain after surgery. Conditioned pain modulation, threshold tracking and quantitative sensory testing will also be assessed in subgroup of patients.

The prospective cohort will be assessed before surgery then 3, 6 and 12 months after surgery. The cross sectional cohort will be assessed during one to two visits in hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing surgery for breast cancer or thoracotomy for lung cancer followed during the course of the study or patients from the French cohort Seintinelle already operated from breast surgery over the past 2 years.

Exclusion criteria :

• Patients are not included if they have clinically significant or unstable psychiatric or somatic conditions (e.g. major depression, psychosis, uncontrolled diabetes mellitus or hypertension, neurological disorders, immune disease, body mass index > 45), past or present substance abuse or any cognitive deterioration based on past medical history, semi-structured interview and lack of completion or full understanding of questionnaires.

• Bilateral mastectomy (for women undergoing breast surgery)

• Presence of pain before surgery

Related Conditions & MeSH terms

• Neuralgia
• Surgery

Locations

Country	Name	City	State
France	Hôpital Ambroise Paré	Boulogne Billancourt
France	Hôpital Foch	Suresnes	Hauts De Seine

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris	Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropathic pain	neuropathic pain assessed with the DN4 questionnaire	3, 6 and 12 months after surgery in the prospective cohort
Secondary	chronic postsurgical pain	chronic pain questionnaire identification	3, 6 and 12 months after surgery