- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06829108
Association of Transversus Abdominis Plane Block (TAPB) with Postoperative Delirium (POD) in Elderly Patients Undergoing Major Gastrointestinal Surgery
February 14, 2025 updated by: Weidong Mi, Chinese PLA General Hospital
Association of Transversus Abdominis Plane Block (TAPB) with Postoperative Delirium (POD) in Elderly Patients Undergoing Major Gastrointestinal Surgery: a Retrospective Cohort Study
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.
Study Overview
Status
Completed
Detailed Description
Postoperative delirium (POD) is a common neurocognitive disorder in elderly patients after surgery, which is characterized by attention deficit, memory impairment and confusion, usually occurring within one week after surgery.
It occurs in 11%-51% of elderly patients undergoing gastrointestinal surgery and is associated with long-term poor prognosis such as dementia and increased mortality.
Risk factors include advanced age, high ASA grade, hypoalbuminemia, and prolonged anesthesia.
Regional nerve block (NBs), as the core means of multimodal analgesia, has been shown to reduce the incidence of POD in orthopedic and thoracic surgery by reducing opioid use and stress response, but its effect in elderly gastrointestinal surgery still needs to be further explored.
Transverse abdominal muscle plane block (TAPB) is a commonly used technique in abdominal surgery.
It can effectively control pain and reduce inflammation and stress response by blocking sensory nerves in the abdominal wall.
This study focused on the effect of TAPB on POD in elderly patients undergoing major gastrointestinal surgery, aiming to provide evidence-based evidence for optimizing perioperative anesthesia management.
Study Type
Observational
Enrollment (Actual)
5220
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
TAPB group and non-TAPB group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
POD incidence within 7 days postoperatively
Time Frame: within 7 days postoperatively
|
within 7 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
intraoperative sufentanil dosage
Time Frame: intraoperative
|
intraoperative
|
|
length of hospital stay
Time Frame: no more than 1 year
|
no more than 1 year
|
|
mortality
Time Frame: 30 day after the surgery
|
30 day after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
October 12, 2024
Study Registration Dates
First Submitted
February 11, 2025
First Submitted That Met QC Criteria
February 14, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 14, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGH-TAPB-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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