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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05450172
Other study ID # 49RC22_0203
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2022
Est. completion date January 6, 2025

Study information

Verified date July 2022
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Postoperative transitional pain corresponds to the pain occuring between acute postoperative pain and chronic postsurgical pain (defined as pain persisting for at least 3 months after surgery). We hypothesized that both trajectory and neuropathic component of transitional pain may influence the quality of recovery after thoracic surgery. To test this, we designed an observational study to identify risk factors for incomplete recovery assessed through the QoR-15 questionnaire.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date January 6, 2025
Est. primary completion date October 3, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients - patients scheduled for thoracic surgery (thoracotomy or video-assisted thoracic surgery or surgery for thoracic outlet syndrome) - patients who do not object to the study Exclusion Criteria: - patients non francophone - emergency surgery or revision surgery - patients already included in the study during the previous 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
QoR-15 questionnaire
The QoR-15 is a 15-item questionnaire on postoperative quality of recovery. The DN4 is a 10-item questionnaire on neuropathic pain. Both questionnaires will be given to the patients preoperatively, on postoperative days 2 and 3, and 1, 3 and 6 months after surgery.

Locations

Country Name City State
France CHU Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of pain trajectory and neuropathic component of pain on quality of recovery. An incomplete recovery will be defined as a postoperative QoR-15 score of at least 8 points lower than the preoperative QoR-15 value. The association between both trajectory and neuropathic component of postoperative transitional pain and incomplete recovery will be evaluated. 3 months after surgery.
Secondary Description of trajectory and neuropathic component of postoperative transitional pain. To describe the trajectory and neuropathic component of postoperative transitional pain according to QoR-15 and DN4 successive values. Between postoperative day 2 and 3 months after surgery.
Secondary Impact of the type of surgery on quality of recovery. To assess the impact of thoracotomy or video-assisted thoracic on quality of recovery. 3 months after surgery.
Secondary Impact of pain trajectory, neuropathic component of pain and type of surgery on chronic postsurgical pain prevalence. To assess the impact pain trajectory, neuropathic component of pain and type of surgery on chronic postsurgical pain prevalence. 3 and 6 months after surgery.
Secondary Predictive accuracy of neuropathic pain trajectory on incomplete recovery and chronic postsurgical pain prevalence. To assess the predictive accuracy of neuropathic pain trajectory on incomplete recovery and chronic postsurgical pain prevalence. 3 and 6 months after surgery.
Secondary Correlation between neuropathic componente of chronic postsurgical pain and quality of recovery. To assess the correlation between neuropathic componente of chronic postsurgical pain and quality of recovery. 3 and 6 months after surgery.
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