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Chronic Postsurgical PainNCT05372406

Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders

An observational study of Chronic Postsurgical Pain, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 chronic postsurgical pain in elderly patients and to establish an early-warning models of perioperative pain in elderly patients, so as to improve the ability of… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Chronic Postsurgical Pain
How many people
7,770 participants
Where
1 siteChina
Study dates
1 Apr 2020to 30 Apr 2022
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: hospital based group

Who may be able to join

  • Diagnosis of Chronic postsurgical pain (CPSP) CPSP was made based on the guidelines of the International Society for Pain (CPSP: ICD-11) as follows: Chronic postsurgical pain is chronic pain developing or increasing in intensity after a surgical procedure and persisting beyond the healing process, i.e. at least 3 months after surgery. The pain is either localised to the surgical field, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues). Other causes of pain including infection, malignancy etc. need to be excluded as well as pain continuing from a pre-existing pain problem. Dependent on type of surgery, chronic postsurgical pain often may be neuropathic pain.
  • Geriatric surgical patients ≥65 years old

Who cannot join

  • Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders: Retrospective Analysis of A Multi-Center Prospective Database in China

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 chronic postsurgical pain in elderly patients and to establish an early-warning models 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.

Based on the database, the investigators intend to explore:

  • Perioperative risk assessment methods and early warning models for elderly patients;
  • Practical, safe, and effective risk prevention and control system through subsequent studies.
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 chronic postsurgical pain in elderly patients and to establish an early-warning model of chronic postsurgical pain in elderly patients, so as to improve the ability of assessing the risks of chronic postsurgical pain in elderly patients and providing an early warning.

Being tested
• no intervention
Keywords
elderly, Chronic Postsurgical Pain, Prediction, risk factors, Validation
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • • no interventionOther

    • no intervention
Study groups in NCT05372406
Study groupRoleWhat they receive
training groupelderly patients (aged ≥ 65 years) elderly patients undergo surgeries
Receives: Other: • no intervention
external validation groupelderly patients (aged ≥ 65 years) elderly patients undergo surgeries
Receives: Other: • no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain trajectories after surgery (Numerical Rating Scale)

    Pain intensity was assessed using a numerical rating scale (NRS) from 0 to 10, with zero representing no pain and 10 representing worst imaginable pain. The worst pain intensity was then categorized into two groups: no or mild pain (NRS from 0 to 3) and moderate to severe pain (NRS from 4 to 10).

    Measured: Up to 3 months postoperation

  2. The Brief Pain Inventory-short form

    It measured pain location in the body; pain intensity on an 11-point numerical rating scale (NRS; 0 represents "no pain" and 10 the "worst pain imaginable"); analgesic intake; perception of analgesic relief; and pain interference with daily life on an 11-point NRS (0 "does not interfere and 10"completely interferes") indistinct dimensions (general activity, mood, walking, work, relations with others, sleep, and enjoyment of life). Higher scores represent higher levels of pain interference.

    Measured: Up to 3 months postoperation

Secondary outcomes (6)

  1. Pain Catastrophizing Scale

    The PCS consists of 13 items, and each item is answered with a numeric value between 0 and 4; 0 corresponding to "not at all", and four corresponded to "all the time". Higher scores indicate a higher level of pain catastrophizing, the Chinese version of the PCS has demonstrated a good reliability and validity (Cronbach's alpha was 0.87 and the ICC was 0.97)

    Measured: within 30 days prior to surgery

  2. 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-5L)taken over 3 months(days 1, 3, 7, 30, 90；Day 0 is the day of surgery). The EQ-5D-5L 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: within 30 days prior to surgery , 1, 3, 7, 30, 90 days postoperation

  3. The Hospital Anxiety and Depression Scale

    Comprised by 2 subscales used to measure anxiety and depression through 7 items each. Subscale scores range from 0 to 21 and result from the sum of each item (Likert scale ranging from 0 to 3). Higher scores correspond to higher levels of anxiety and depression.

    Measured: within 30 days prior to surgery , Up to 3 months postoperation

  4. FRAIL Scale

    Frailty was assessed within 30 days prior to surgery using the FRAIL Scale assessment. The FRAIL Scale assessment is a validated 5-item scale comprising components from the Cardiovascular Health Frailty Index and Rockwood Scale.The five components measured include fatigue, resistance, ambulation, illness and loss of weight. The scale was dichotomized into two frailty categories based on prior literature on pain and frailty.16 Patients were classified as frail if they scored 3 or more on the 5-point scale and not frail if they scored below 3 .

    Measured: within 30 days prior to surgery ,Up to 3 months postoperation

  5. 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 3 months postoperation

  6. Postoperative duration of stay in hospital

    The duration when patients stay in hospital after surgery.

    Measured: Up to 3 months postoperation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start1 Apr 2020
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Resources

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
Retrospective
Enrolment
7,770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05372406
Sponsor's protocol ID
PLAGH-CPSP-001
Status last verified
May 2022
First submitted
9 May 2022
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Postsurgical Pain, run by Chinese PLA General 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 1 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 25 May 2022. 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?

Pain trajectories after surgery (Numerical Rating Scale) (time frame: Up to 3 months postoperation). 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?

On the ClinicalTrials.gov record for NCT05372406.

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 25 May 2022.

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