NCT06829108

Brief Summary

Postoperative delirium can increase postoperative adverse reactions and prognosis in elderly patients undergoing gastrointestinal surgery. This study studied the effects of ultrasound-guided transversal plane block on postoperative delirium, opioid consumption and prognosis in elderly patients undergoing gastrointestinal surgery, comprehensively evaluated the effectiveness and safety of TAPB, and evaluated its clinical value.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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

January 1, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
Last Updated

February 17, 2025

Status Verified

August 1, 2024

Enrollment Period

6.2 years

First QC Date

February 11, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

Regional AnaesthesiaPostoperative Delirium (POD)Transversus abdominis plane block (TAP block)

Outcome Measures

Primary Outcomes (1)

  • POD incidence within 7 days postoperatively

    within 7 days postoperatively

Secondary Outcomes (3)

  • intraoperative sufentanil dosage

    intraoperative

  • length of hospital stay

    no more than 1 year

  • mortality

    30 day after the surgery

Study Arms (1)

TAPB group and non-TAPB group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All perioperative data required for this study were obtained from patients at the First Medical Center of the Chinese PLA General Hospital from January 2016 to March 2022.

You may qualify if:

  • age ≥65 years;
  • major gastrointestinal surgery, defined as procedures lasting more than one hour and involving partial resection of the stomach or intestines;
  • general anesthesia with endotracheal intubation.

You may not qualify if:

  • emergency surgeries;
  • transanal endoscopic microsurgery (TEM);
  • patients with a history of preoperative delirium, altered consciousness, or psychiatric conditions, such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, and anxiety or depressive disorders, as well as encephalopathies (hepatic, pulmonary, and renal) and hydrocephalus, along with those experiencing significant preoperative visual or auditory impairments;
  • patients who died within 24 h postoperatively or missing data of \>50% in their medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zhang C, Gao T, Ma HY, Wang R, Sun JJ, Ma LB, Tong L, Fu Q. Association of transversus abdominis plane block (TAPB) with postoperative delirium (POD) in elderly patients undergoing major gastrointestinal surgery: a retrospective cohort study. BMC Anesthesiol. 2025 Sep 29;25(1):464. doi: 10.1186/s12871-025-03363-w.

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Anesthesiology (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

January 1, 2016

Primary Completion

March 31, 2022

Study Completion

October 12, 2024

Last Updated

February 17, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share