NCT07744308

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,754

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

4.1 years

First QC Date

July 26, 2026

Last Update Submit

July 29, 2026

Conditions

Outcome Measures

Primary Outcomes (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).

    Three months after the operation

Secondary Outcomes (5)

  • The incidence of postoperative pain interference three months after the operation

    Three months after the operation

  • Pain severity score

    Three months after the operation

  • Pain interference score

    Three months after the operation

  • EQ-5D-5L

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

  • EQ VAS

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, China

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Wei dong Mi, MD, PhD

    Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital

Study Record Dates

First Submitted

July 26, 2026

First Posted

August 4, 2026

Study Start

April 1, 2020

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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

Locations