Impact of Postoperative Transitional Pain on Recovery After Thoracic Surgery (TRANSAT)

July 8, 2022 updated by: University Hospital, Angers
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for thoracic surgery (thoracotomy or video-assisted thoracic surgery or surgery for thoracic outlet syndrome).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Consecutive patients scheduled for thoracic surgery
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.
Other Names:
  • DN4 questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of pain trajectory and neuropathic component of pain on quality of recovery.
Time Frame: 3 months after surgery.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of trajectory and neuropathic component of postoperative transitional pain.
Time Frame: Between postoperative day 2 and 3 months after surgery.
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.
Impact of the type of surgery on quality of recovery.
Time Frame: 3 months after surgery.
To assess the impact of thoracotomy or video-assisted thoracic on quality of recovery.
3 months after surgery.
Impact of pain trajectory, neuropathic component of pain and type of surgery on chronic postsurgical pain prevalence.
Time Frame: 3 and 6 months after surgery.
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.
Predictive accuracy of neuropathic pain trajectory on incomplete recovery and chronic postsurgical pain prevalence.
Time Frame: 3 and 6 months after surgery.
To assess the predictive accuracy of neuropathic pain trajectory on incomplete recovery and chronic postsurgical pain prevalence.
3 and 6 months after surgery.
Correlation between neuropathic componente of chronic postsurgical pain and quality of recovery.
Time Frame: 3 and 6 months after surgery.
To assess the correlation between neuropathic componente of chronic postsurgical pain and quality of recovery.
3 and 6 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 20, 2022

Primary Completion (ANTICIPATED)

October 3, 2024

Study Completion (ANTICIPATED)

January 6, 2025

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (ACTUAL)

July 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 49RC22_0203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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