Regional AnaesthesiaNCT06829108
Association of Transversus Abdominis Plane Block (TAPB) with Postoperative Delirium (POD) in Elderly Patients Undergoing Major Gastrointestinal Surgery
An observational study of Regional Anaesthesia and Postoperative Delirium (POD), run by Chinese PLA General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Regional Anaesthesia, Postoperative Delirium (POD), Transversus Abdominis Plane Block (TAP Block)
- How many people
- 5,220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 12 Oct 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Regional Anaesthesia, Postoperative Delirium (POD), Transversus Abdominis Plane Block (TAP Block)
- Keywords
- Regional Anaesthesia, Postoperative Delirium (POD), Transversus abdominis plane block (TAP block)
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAPB group and non-TAPB group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
POD incidence within 7 days postoperatively
Measured: within 7 days postoperatively
Secondary outcomes (3)
intraoperative sufentanil dosage
Measured: intraoperative
length of hospital stay
Measured: no more than 1 year
mortality
Measured: 30 day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Jan 2016
- Primary completion31 Mar 2022
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 5,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829108
- Sponsor's protocol ID
- PLAGH-TAPB-001
- Status last verified
- Aug 2024
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41023630
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Transversus Abdominis Plane Block (TAPB) with Postoperative Delirium (POD) in Elderly Patients Undergoing Major Gastrointestinal Surgery: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06829108
- Acronym / sponsor ID
- PLAGH-TAPB-001
- Conditions
- Regional Anaesthesia, Postoperative Delirium (POD), Transversus Abdominis Plane Block (TAP Block)
- Keywords
- Regional Anaesthesia, Postoperative Delirium (POD), Transversus abdominis plane block (TAP block)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,220 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAPB group and non-TAPB group | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
POD incidence within 7 days postoperatively
Time frame: within 7 days postoperatively
3 secondary outcomes
intraoperative sufentanil dosage
Time frame: intraoperative
length of hospital stay
Time frame: no more than 1 year
mortality
Time frame: 30 day after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 41023630Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anaesthesia and Postoperative Delirium (POD), run by Chinese PLA General Hospital.
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 3 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
POD incidence within 7 days postoperatively (time frame: within 7 days postoperatively). 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 NCT06829108, which also lists 1 linked publication.
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 17 Feb 2025.