Pain, PostoperativeNCT05473728
Epidemiology Study and Risk Factor Analysis on Chronic Post-surgical Pain After Video-assisted Thoracic Surgery
An observational study of Pain, Postoperative, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a nationwide multi-center study to investigate the incidence and risk factors of chronic post-surgical pain (CPSP) after receiving video-assisted thoracic surgery (VATS). Patients receiving VATS in participating centers across China in Aug. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- How many people
- 886 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Our research focuses on the incidence of CPSP after VATS in Chinese population. So, our target population will be all the Chinese patients receiving VATS in China. To select an accessible population that can well represent the target population, we set geographic criteria as regional medical centers in all seven geographical subregions of China, namely northwestern China, northern China, northeastern China, central China, southern China, southwestern China and southeastern China. Considering the needed sample size and the cost, we set time criteria as one month. Therefore, the accessible population in our study is all the patients receiving VATS in Aug., 2022 at selected medical centers in all seven geographical subregions of China.
Who may be able to join
- In-patients at participating medical centers
- Scheduled for unilateral VATS during the study enrollment period
Who cannot join
- Emergency surgeries
- Patients with known pain sensory impairment
- Patients cannot express themselves so that an NRS score cannot be measured
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nationwide Multi-center Epidemiology Study and Risk Factor Analysis on Chronic Post-surgical Pain After Video-assisted Thoracic Surgery
This study is a nationwide multi-center study to investigate the incidence and risk factors of chronic post-surgical pain (CPSP) after receiving video-assisted thoracic surgery (VATS). Patients receiving VATS in participating centers across China in Aug. 2022 will be assessed for eligibility, and all the enrolled patients will be followed up for at least 6 months. The study's primary outcome is the incidence of CPSP 6 months after VATS. Baseline demographic, psychological , surgical, anesthesia-related and pain-related characteristics will be evaluated for possible risk factors of CPSP after VATS.
Read the detailed description
Study Overview This is a multi-center perspective cohort study on the incidence and risk factors of CPSP after VATS.
Study aims
- Investigate the incidence of chronic post-surgical pain in Chinese population who received video-assisted thoracic surgery by carrying out a multi-center, perspective cohort study
- Perform regression analysis to evaluate the risk factors for chronic post-surgical pain in video-assisted thoracoscopic surgery.
- Establish a risk-prediction model for CPSP after VATS
Time frame:
We plan to recruit patients from Aug 1st, 2022 to Sept 1st, 2022. And our follow-up will be performed at 1 month, 3 months and 6 months after the surgeries. After completing the follow-up of all patients, we are going to build a risk-prediction model and have it validated.
Study subjects Our research focuses on the incidence of CPSP after VATS in Chinese population. To select an accessible population that can well represent the target population, we set geographic criteria as regional medical centers in all seven geographical subregions of China, namely northwestern China, northern China, northeastern China, central China, southern China, southwestern China and southeastern China. Considering the needed sample size and the cost, we set time criteria as one month.
Plan for sampling As described before, our study plans to sample all the patients receiving VATS in participating medical centers across China for one month.
Plan for recruitment All patients receiving VATS in our participating centers will be examined for recruitment by the local coordinators according to our inclusion and exclusion criteria.
Plan for retaining subjects We are going to follow up the patients for at least 6 months after the surgery. At the pre-Op visit, the patient will be informed of the study time frame and he/she will be called by researcher in PUMCH during their follow-up. After their discharge, we will contact the patients and call them at 1, 3, 6 months after surgery.
Patient Registries We will use standard case report form (CRF) and electronic data capture (EDC) system for patient registries. All the data required in this study will be obtained by patient interview and medical records and recorded in our CRF and uploaded into EDC system. Researchers in participating centers will collect patient information by interview during their stay at the hospital. An SOP and interviewer training session will be developed for the study. The EDC system will help with data check, data dictionary. And our data monitoring board in PUMCH will check the uploaded data while follow-up telephoning the patients.
Statistical analysis plan Sample size Expected incidence: 30% Comment: the average reported incidence of CPSP after VATS Desired precision: 10% (total width) Confidence level: 95% Therefore, the estimated sample size with the above-mentioned parameters is 323 The risk factors will be analyzed by Logistics regression.
- Conditions
- Pain, Postoperative
- Keywords
- Video-assisted thoracic surgery, Chronic post-surgical pain, Epidemiology study, risk factors
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
post-surgical pain-6 month
Asking patients about the existence of chronic pain related to surgery by telephone interview
Measured: 6 month after the VATS
Secondary outcomes (2)
post-surgical pain-3 month
Asking patients about the existence of chronic pain related to surgery by telephone interview
Measured: 3 month after the VATS
Influence on quality of life
Assessed by BPI-SF influence part
Measured: 3\6 month after the VATS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Aug 2022
- Primary completion1 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University Cancer Institute and Hospital, First Affiliated Hospital of Chongqing Medical University, Xiangya Hospital of Central South University, Shanghai Chest Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The people's hospital of Xinjiang, Cancer hospital affiliated to Xinjiang Medical Universtity, Gansu provincial hospital of TCM, Tibet Autonomous Region People's Hospital
- Responsible party
- Sponsor
- Investigators
- Le Shen, M.D., Ph.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473728
- Sponsor's protocol ID
- ZS-3560
- Status last verified
- May 2024
- First submitted
- 24 Jul 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In terms to patient's privacy, only the overall statistics will be reported. (i.e. incidence, risk factors, demographic characteristics). Individual date will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Multi-center Epidemiology Study and Risk Factor Analysis on Chronic Post-surgical Pain After Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05473728
- Acronym / sponsor ID
- ZS-3560
- Conditions
- Pain, Postoperative
- Keywords
- Video-assisted thoracic surgery, Chronic post-surgical pain, Epidemiology study, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University Cancer Institute and Hospital, First Affiliated Hospital of Chongqing Medical University, Xiangya Hospital of Central South University, Shanghai Chest Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The people's hospital of Xinjiang, Cancer hospital affiliated to Xinjiang Medical Universtity, Gansu provincial hospital of TCM, Tibet Autonomous Region People's Hospital
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a nationwide multi-center study to investigate the incidence and risk factors of chronic post-surgical pain (CPSP) after receiving video-assisted thoracic surgery (VATS). Patients receiving VATS in participating centers across China in Aug. 2022 will be assessed for eligibility, and all the enrolled patients will be followed up for at least 6 months. The study's primary outcome is the incidence of CPSP 6 months after VATS. Baseline demographic, psychological , surgical, anesthesia-related and pain-related characteristics will be evaluated for possible risk factors of CPSP after VATS.
Detailed description
Study Overview This is a multi-center perspective cohort study on the incidence and risk factors of CPSP after VATS.
Study aims
- Investigate the incidence of chronic post-surgical pain in Chinese population who received video-assisted thoracic surgery by carrying out a multi-center, perspective cohort study
- Perform regression analysis to evaluate the risk factors for chronic post-surgical pain in video-assisted thoracoscopic surgery.
- Establish a risk-prediction model for CPSP after VATS
Time frame:
We plan to recruit patients from Aug 1st, 2022 to Sept 1st, 2022. And our follow-up will be performed at 1 month, 3 months and 6 months after the surgeries. After completing the follow-up of all patients, we are going to build a risk-prediction model and have it validated.
Study subjects Our research focuses on the incidence of CPSP after VATS in Chinese population. To select an accessible population that can well represent the target population, we set geographic criteria as regional medical centers in all seven geographical subregions of China, namely northwestern China, northern China, northeastern China, central China, southern China, southwestern China and southeastern China. Considering the needed sample size and the cost, we set time criteria as one month.
Plan for sampling As described before, our study plans to sample all the patients receiving VATS in participating medical centers across China for one month.
Plan for recruitment All patients receiving VATS in our participating centers will be examined for recruitment by the local coordinators according to our inclusion and exclusion criteria.
Plan for retaining subjects We are going to follow up the patients for at least 6 months after the surgery. At the pre-Op visit, the patient will be informed of the study time frame and he/she will be called by researcher in PUMCH during their follow-up. After their discharge, we will contact the patients and call them at 1, 3, 6 months after surgery.
Patient Registries We will use standard case report form (CRF) and electronic data capture (EDC) system for patient registries. All the data required in this study will be obtained by patient interview and medical records and recorded in our CRF and uploaded into EDC system. Researchers in participating centers will collect patient information by interview during their stay at the hospital. An SOP and interviewer training session will be developed for the study. The EDC system will help with data check, data dictionary. And our data monitoring board in PUMCH will check the uploaded data while follow-up telephoning the patients.
Statistical analysis plan Sample size Expected incidence: 30% Comment: the average reported incidence of CPSP after VATS Desired precision: 10% (total width) Confidence level: 95% Therefore, the estimated sample size with the above-mentioned parameters is 323 The risk factors will be analyzed by Logistics regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our research focuses on the incidence of CPSP after VATS in Chinese population. So, our target population will be all the Chinese patients receiving VATS in China. To select an accessible population that can well represent the target population, we set geographic criteria as regional medical centers in all seven geographical subregions of China, namely northwestern China, northern China, northeastern China, central China, southern China, southwestern China and southeastern China. Considering the needed sample size and the cost, we set time criteria as one month. Therefore, the accessible population in our study is all the patients receiving VATS in Aug., 2022 at selected medical centers in all seven geographical subregions of China.
Key inclusion criteria (2 listed)
- In-patients at participating medical centers
- Scheduled for unilateral VATS during the study enrollment period
Key exclusion criteria (3 listed)
- Emergency surgeries
- Patients with known pain sensory impairment
- Patients cannot express themselves so that an NRS score cannot be measured
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post-surgical pain-6 month
Time frame: 6 month after the VATS
Asking patients about the existence of chronic pain related to surgery by telephone interview
2 secondary outcomes
post-surgical pain-3 month
Time frame: 3 month after the VATS
Influence on quality of life
Time frame: 3\6 month after the VATS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No. In terms to patient's privacy, only the overall statistics will be reported. (i.e. incidence, risk factors, demographic characteristics). Individual date will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Le Shen, M.D., Ph.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-surgical pain-6 month (time frame: 6 month after the VATS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.