Postoperative PainNCT04228705
Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders
An observational study of Postoperative Pain and Pain Assessment, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study will collect perioperative pain-related data of elderly patients in multi-centers. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Pain Assessment, Elderly
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2019to 12 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older undergoing general or regional anesthesia of any procedures, mainly include: breast surgery, thoracic surgery, abdominal surgery, total knee or hip replacement surgery and spine surgery.
Who may be able to join
- 18 years or older
- Undergoing general or regional anesthesia
- Hospitalized for at least 24 hours after surgery
- Able to give informed consent
- Able to read and write
Who cannot join
- Existing diagnoses of psychiatric or neurologic pathology
- A history of substance abuse
- Admitted to ICU after surgery
- Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yi Feng, MD, 08601088325590, yifeng65@sina.com
About this study
Official title: Study on Comprehensive Strategy of Perioperative Pain Prevention and Treatment in Elderly Patients -- Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders
This study will collect perioperative pain-related data of elderly patients in multi-centers. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.
Read the detailed description
This study will collect perioperative pain-related data of elderly patients in multi-centers, including: preoperative general data, intraoperative anesthesia and surgical data, clinical laboratory data, postoperative pain and intervention, postoperative complications and quality of life. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.
- Conditions
- Postoperative Pain, Pain Assessment, Elderly, Model
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The elders | Patients aged over 59 years old | |
| The young adults | Patients aged from 18 to 59 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain trajectories after surgery
The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with pain severity domain of the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Measured: within 6 months
Pain trajectories after surgery
The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with Brief Pain Inventory -Short Form (BPI-SF) within 6 months
Measured: within 6 months
Secondary outcomes (7)
Outcome of 6-mins-walking test
Walking distance of 6 minutes
Measured: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
Postoperative duration of stay in hospital
The duration when patients stay in hospital after surgery.
Measured: 30 days postoperation
Number of readmission within 30 days after surgery
Readmission indicates unplanned readmission after hospital discharge.
Measured: Up to 30 days postoperation
Complications within 30 days after surgery
Complications within 30 days after surgery will be classified using Clavien-Dindo Classification of Surgical Complications, ranging from Grade I(Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions) to Grade V(death of a patient).
Measured: Up to 30 days postoperation
The trajectories of health related quality of life(HRQoL)
The trajectory of HRQoL is the vector of Utility values measured with EuroQol five-dimensional questionnaire(EQ-5D)taken over 6 months(days 1, 3, 7,14, 21, 30, 60, 90, 120, 150,180; Day 0 is the day of surgery). The EQ-5D measures health on five domains (mobility, self-care, usual activities, pain discomfort, and anxiety-depression), and the scores will be combined using Chinese general population weights to generate a single utility or index score. Utility values for the EQ-5D range from 1.00 to -0.391, where a score of 0 and 1 are regarded as equivalent to death and 'perfect health', respectively, and a score < 0 is considered as health state that is 'worse than death'.
Measured: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
Ambulation time
The first time when patients can get off of bed and walk after surgery
Measured: Up to 30 days postoperation
Oral feeding time
The first time when patients begin oral feeding after surgery
Measured: Up to 30 days postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start13 Dec 2019
- Primary completion12 Dec 2020 (estimated)
- Study completion12 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, Zhejiang University
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Feng Yi, MD, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228705
- Sponsor's protocol ID
- 2019PHB258-01
- Status last verified
- Jan 2020
- First submitted
- 12 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Comprehensive Strategy of Perioperative Pain Prevention and Treatment in Elderly Patients -- Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders
- ClinicalTrials.gov ID
- NCT04228705
- Acronym / sponsor ID
- 2019PHB258-01
- Conditions
- Postoperative Pain, Pain Assessment, Elderly, Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, Zhejiang University
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 12 Dec 2020 (estimated)
- Study completion
- 12 Dec 2020 (estimated)
- First posted
- 14 Jan 2020 (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 will collect perioperative pain-related data of elderly patients in multi-centers. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.
Detailed description
This study will collect perioperative pain-related data of elderly patients in multi-centers, including: preoperative general data, intraoperative anesthesia and surgical data, clinical laboratory data, postoperative pain and intervention, postoperative complications and quality of life. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The elders | – | –Patients aged over 59 years old |
| The young adults | – | –Patients aged from 18 to 59 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older undergoing general or regional anesthesia of any procedures, mainly include: breast surgery, thoracic surgery, abdominal surgery, total knee or hip replacement surgery and spine surgery.
Key inclusion criteria (5 listed)
- 18 years or older
- Undergoing general or regional anesthesia
- Hospitalized for at least 24 hours after surgery
- Able to give informed consent
- Able to read and write
Key exclusion criteria (4 listed)
- Existing diagnoses of psychiatric or neurologic pathology
- A history of substance abuse
- Admitted to ICU after surgery
- Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.
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
Pain trajectories after surgery
Time frame: within 6 months
The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with pain severity domain of the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Pain trajectories after surgery
Time frame: within 6 months
The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with Brief Pain Inventory -Short Form (BPI-SF) within 6 months
7 secondary outcomes
Outcome of 6-mins-walking test
Time frame: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
Postoperative duration of stay in hospital
Time frame: 30 days postoperation
Number of readmission within 30 days after surgery
Time frame: Up to 30 days postoperation
Complications within 30 days after surgery
Time frame: Up to 30 days postoperation
The trajectories of health related quality of life(HRQoL)
Time frame: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
Ambulation time
Time frame: Up to 30 days postoperation
Oral feeding time
Time frame: Up to 30 days postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
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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.
Feng Yi, MD, PhD principal investigator
Peking University People's 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 Postoperative Pain and Pain Assessment, run by Peking University People's 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Yi, MD, PhD (86-010-88325590, yifeng65@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain trajectories after surgery (time frame: within 6 months). The study lists 2 primary outcomes in all. 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 14 Jan 2020.