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Chronic Postoperative PainNCT07744308

Effect of Intraoperative Dexmedetomidine on Postoperative Pain in Elderly Patients Undergoing Major Abdominal Surgery: a Secondary Analysis Based on Prospective Data

An observational study of Chronic Postoperative 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 is a secondary analysis of multicenter prospective data, including elderly patients who underwent elective major abdominal surgery between April 2020 and April 2022 from a perioperative database of elderly patients in China. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Chronic Postoperative Pain
How many people
2,754 participants
Where
1 siteChina
Study dates
1 Apr 2020to 30 Apr 2024
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: This study is a secondary analysis based on a multi-center prospective database. We included 2,754 elderly patients who underwent major abdominal surgeries at five medical centers from April 2020 to April 2022. The data were sourced from Perioperative Database of Elderly Patients in China, which is a multi-center prospective study. The main objective of this parent study is to identify the perioperative risk factors for elderly non-cardiac surgery patients and establish a targeted risk prevention and management plan.

Who may be able to join

  • Age ≥ 65 years;
  • Underwent elective gastrointestinal and hepatobiliary surgeries.

Who cannot join

  • Patients with ASA grade IV or above;
  • Patients with missing exposure factor data;
  • Patients without postoperative pain assessment data;
  • Patients transferred to the ICU after surgery or who died within 7 days after surgery.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Anesthesiology, First Medical Center of the People's Liberation Army General Hospital, Beijing, Haidian 100853

    Beijing

Other trials in China

About this study

This study is a secondary analysis of multicenter prospective data, including elderly patients who underwent elective major abdominal surgery between April 2020 and April 2022 from a perioperative database of elderly patients in China. This study aims to evaluate the impact of intraoperative dexmedetomidine on chronic postoperative pain in elderly patients undergoing major abdominal surgery, with a comprehensive analysis of pain across multiple dimensions.

Read the detailed description

This study is a secondary analysis of multicenter prospective data, including elderly patients who underwent elective major abdominal surgery between April 2020 and April 2022 from a perioperative database of elderly patients in China. In this study, we specifically extracted and analyzed the data at the 3-month follow-up time point after abdominal major surgeries in elderly patients to evaluate the association between the intraoperative use of dexmedetomidine and postoperative chronic pain (CPSP) in this elderly patient population.

Exposure definition: Patients who received dexmedetomidine (dose range 0.2-1.0 μg/kg·h) for anesthesia induction or maintenance during the operation were defined as exposed, while those who did not receive it were the unexposed group.

Primary outcome: The primary outcome was the incidence of postoperative pain at 3 months, assessed using the Brief Pain Inventory (BPI).

Secondary outcomes: Secondary outcomes included pain severity, pain interference score, and health-related quality of life at 7 days, 1 month, and 3 months after surgery. Pain indicators were evaluated using the Brief Pain Inventory (BPI), and health-related quality of life was assessed using the EQ-5D-5L scale.

Statistical analysis: Missing covariates were handled using multiple imputation (m = 25), and potential confounders were controlled using inverse probability weighting (IPTW). Considering hospital clustering, all regression models had hospital as a random effect. A weighted logistic regression model was used to assess the impact of dexmedetomidine on the incidence of pain, a log-linear model was used to analyze pain severity scores and pain interference scores, and a linear mixed-effects model was used to analyze changes in health-related quality of life at the three time points after surgery.

Sample size and statistical power: Sample size estimation was based on previous literature. A prospective cohort study of patients undergoing gastrointestinal surgery showed that the incidence of chronic pain 3 months after surgery was 30.58% . Based on the results of a meta-analysis , the incidence of chronic pain 3 months after surgery in patients using dexmedetomidine was estimated to be reduced to 15.6%. Based on the distribution of patients meeting the inclusion and exclusion criteria in the database, the sample size ratio between the treatment group and the non-treatment group was approximately 1:2. Using PASS 2021 software, continuity correction was set, and under the two-sided test level α = 0.05 and test power 1 - β = 0.80, 251 patients (84 in the treatment group and 167 in the non-treatment group) were required. Considering a 20% dropout rate, the total sample size should be at least 314 cases (105 in the treatment group and 209 in the non-treatment group).

Data processing and quality control: All data will be extracted by trained researchers from the database.

Ethical considerations: Since this study only conducts a secondary analysis of anonymized existing data, the ethics committee waived the requirement for obtaining additional written informed consent from the participants. This study will be conducted in accordance with the Helsinki Declaration and relevant local regulations.

Medical subject headings
Pain, Postoperative

What is being measured

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

  1. The incidence of postoperative pain severity three months after the operation

    The incidence of postoperative pain severity three months after the operation using the Brief Pain Inventory (BPI). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain). The scores of these four items are summed up and averaged. Then, this average value is multiplied by 10 to convert it into a standard score ranging from 0 to 100. The incidence of chronic postoperative pain is defined as a score of ≥ 10 after conversion (that is, the original average score is ≥ 1).

    Measured: Three months after the operation

Secondary outcomes (5)

  1. The incidence of postoperative pain interference three months after the operation

    The incidence of postoperative pain interference three months after the operation using the Brief Pain Inventory (BPI). The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The pain scores of these seven items were summed up, and the average value was calculated. Then, this average value was multiplied by 10 to convert it into a standard score ranging from 0 to 100. The incidence of postoperative pain interference was defined as a converted score of ≥ 10 (that is, the original average score ≥ 1).

    Measured: Three months after the operation

  2. Pain severity score

    Pain severity score: the BPI assesses pain at its "worst," "least," "average," and "now" (current pain). The scores of these four items are summed up and averaged. Then, this average value is multiplied by 10 to convert it into a standard score ranging from 0 to 100.

    Measured: Three months after the operation

  3. Pain interference score

    Pain interference score: the BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The pain scores of these seven items were summed up, and the average value was calculated. Then, this average value was multiplied by 10 to convert it into a standard score ranging from 0 to 100.

    Measured: Three months after the operation

  4. EQ-5D-5L

    At 7 days, 1 month and 3 months after the surgery, the European Five-Dimensional Health Scale (EQ-5D-5L) were used to assess the dynamic changes in postoperative health-related quality of life. It includes five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression (the utility values converted according to Chinese standards quantify the health status of patients). The health status effect value range of EQ-5D-5L is from -0.391 to 1. A score lower than 0 indicates "worse than death", 0 indicates "no quality of life" or "death", and 1 indicates complete health.

    Measured: At 7 days, 1 month and 3 months after the surgery

  5. EQ VAS

    The overall health visual analogue score (EQ VAS) of the European Five-Dimensional Health Scale (EQ-5D-5L) was used to quantify the health status of the patients. The EQ VAS score ranges from 0 to 100, with a higher score indicating better function.

    Measured: At 7 days, 1 month and 3 months after the surgery

Timeline

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

  1. First posted4 Aug 2026
  2. Study start1 Apr 2020
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

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
2,754 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07744308
Sponsor's protocol ID
PLAGH S2025-917-01
Status last verified
Jul 2026
First submitted
26 Jul 2026
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) generated in this study are not planned to be shared publicly. The data contain sensitive personal health information and are subject to confidentiality protections under the ethical approval and data management regulations governing this research. Data access is restricted to the immediate research team for the purposes outlined in the approved study protocol

Publications

  • Zeng M, Xu X, Li R, Zhang X, Ma T, Cui Q, Wang J, Li S, Peng Y. Dexmedetomidine Prevents Chronic Incisional Pain After Brain Tumor Resection: A Secondary Analysis of the Randomized Control Trial. Anesth Analg. 2024 Apr 1;138(4):839-847. doi: 10.1213/ANE.0000000000006563. Epub 2023 Jun 12.

    PubMed 37307232

  • Maurice-Szamburski A, Bringuier S, Auquier P, Capdevila X. From pain level to pain experience: redefining acute pain assessment to enhance understanding of chronic postsurgical pain. Br J Anaesth. 2024 Nov;133(5):1021-1027. doi: 10.1016/j.bja.2024.08.003. Epub 2024 Sep 26.

    PubMed 39332996

  • Doleman B, Mathiesen O, Sutton AJ, Cooper NJ, Lund JN, Williams JP. Non-opioid analgesics for the prevention of chronic postsurgical pain: a systematic review and network meta-analysis. Br J Anaesth. 2023 Jun;130(6):719-728. doi: 10.1016/j.bja.2023.02.041. Epub 2023 Apr 12.

    PubMed 37059625

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Postoperative 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 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: finished, as of the sponsor's last update on 4 Aug 2026. 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?

The incidence of postoperative pain severity three months after the operation (time frame: Three months after the operation). 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 NCT07744308, which also lists 3 linked publications.

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 4 Aug 2026.

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