Regional AnaesthesiaNCT07013721
Transversus Abdominis Plane Block on Postoperative Analgesic Efficacy in Elderly Patients Undergoing Minimally Invasive Gastrointestinal Tumor Surgery
A study testing Transversus Abdominis Plane Block, TAPB in people with Regional Anaesthesia and Transversus Abdominis Plane Block (TAP Block), run by Chinese PLA General Hospital.
Trial summary
Elderly patients undergoing minimally invasive gastrointestinal tumor surgery face complex postoperative pain management due to age-related physiological decline and surgical particularities, where traditional opioids are prone to adverse effects. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Regional Anaesthesia, Transversus Abdominis Plane Block (TAP Block), Pain, Postoperative
- What is being tested?
- Transversus Abdominis Plane Block, TAPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Elderly patients scheduled for elective minimally invasive gastrointestinal tumor surgery under general anesthesia
- Age ≥65 years
- American Society of Anesthesiologists (ASA) physical status classification ≤III
- Body mass index (BMI) 18-30 kg/m²
Who cannot join
- Allergy to anesthetic agents
- Preoperative chronic pain or chronic use of opioids/nonsteroidal anti-inflammatory drugs (NSAIDs)
- Contraindications to regional blockade:Local infection at puncture site
- , Coagulopathy (INR >1.5, platelet count <80×10⁹/L)
- There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold
- Preoperative neurological/psychiatric disorders:Consciousness alterations, Epilepsy, Alzheimer's disease, Parkinson's disease, Schizophrenia, Anxiety or depressive disorders, Hepatic, pulmonary, or renal encephalopathy
- Recent stroke history
- Postoperative admission to intensive care unit (ICU)
About this study
Official title: A Clinical Study on the Effect of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Analgesic Efficacy in Elderly Patients Undergoing Minimally Invasive Gastrointestinal Tumor Surgery
Elderly patients undergoing minimally invasive gastrointestinal tumor surgery face complex postoperative pain management due to age-related physiological decline and surgical particularities, where traditional opioids are prone to adverse effects. Our study investigates the clinical analgesic efficacy of ultrasound-guided transversus abdominis plane block (TAPB) in these patients, focusing on analgesic quality, delirium incidence, opioid consumption, and postoperative recovery indicators. This evaluation aims to assess its clinical value and safety while providing evidence-based insights for optimizing perioperative analgesia protocols.
Read the detailed description
Globally, approximately 30% of surgical patients experience moderate to severe acute postoperative pain annually, with 11% developing severe acute postoperative pain. Inadequate pain control and analgesic administration may precipitate adverse outcomes such as postoperative delirium, a complication particularly prevalent in elderly populations. The concept of multimodal analgesia has emerged to enhance therapeutic efficacy, mitigate adverse effects associated with monotherapy, accelerate postoperative rehabilitation, and improve patient satisfaction. The transversus abdominis plane block constitutes a critical component of multimodal analgesic strategies.
This randomized controlled trial was conducted to compare the differences in postoperative analgesic efficacy between the transversus abdominis plane block intervention group and the non-intervention control group among elderly patients undergoing minimally invasive gastrointestinal tumor surgery. Key evaluation parameters included postoperative pain intensity (assessed via validated pain scales), incidence of postoperative delirium, opioid consumption , and comprehensive postoperative recovery metrics (e.g., length of hospitalization). The study concurrently evaluated the clinical safety profile of transversus abdominis plane block through systematic monitoring of procedure-related complications and adverse events, thereby providing evidence-based data to refine perioperative analgesic protocols and optimize Enhanced Recovery After Surgery (ERAS) pathways in geriatric surgical populations.
- Being tested
- Transversus Abdominis Plane Block, TAPB
- Keywords
- Regional Anaesthesia, Transversus abdominis plane block (TAP block), Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane Block, TAPBProcedure or surgery
The procedure was performed by anesthesiologists with extensive expertise in nerve blockade techniques. For upper abdominal surgical incisions, a subcostal approach transversus abdominis plane block (TAPB) was implemented under ultrasound guidance to identify the transversus abdominis plane. A total of 20 mL of 0.33% ropivacaine hydrochloride injection (Naropin®) was incrementally administered, followed by contralateral application using identical techniques, with ultrasonographic confirmation of fusiform drug distribution within the transversus abdominis plane to achieve upper abdominal incision analgesia. For lower abdominal incisions, a lateral approach was employed, with the same dosage of local anesthetic injected at the target site and bilateral blocks performed after confirming fluid dispersion patterns under real-time ultrasound visualization.
| Study group | Role | What they receive |
|---|---|---|
| transversus abdominis plane block group | Experimental | The procedure was performed by anesthesiologists with extensive expertise in nerve blockade techniques. For upper abdominal surgical incisions, a subcostal approach transversus abdominis plane block (TAPB) was implemented under ultrasound guidance to identify the transversus abdominis plane. A total of 20 mL of 0.33% ropivacaine hydrochloride injection (Naropin®) was incrementally administered, followed by contralateral application using identical techniques, with ultrasonographic confirmation of fusiform drug distribution within the transversus abdominis plane to achieve upper abdominal incision analgesia. For lower abdominal incisions, a lateral approach was employed, with the same dosage of local anesthetic injected at the target site and bilateral blocks performed after confirming fluid dispersion patterns under real-time ultrasound visualization. Receives: Procedure: Transversus Abdominis Plane Block, TAPB |
| Non-intervention Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain scores using Numerical Rating Scale (NRS). The Numerical Rating Scale (NRS) assesses pain intensity through patient self-reporting on an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Patients independently select a single number reflecting their current pain level without clinician interpretation.
Measured: 24 hours after surgery
Secondary outcomes (8)
pain score
Resting and movement pain scores using Numerical Rating Scale (NRS). The Numerical Rating Scale (NRS) assesses pain intensity through patient self-reporting on an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Patients independently select a single number reflecting their current pain level without clinician interpretation.
Measured: 1, 6, and 48 hours after surgery
postoperative delirium during hospitalization
The 3D-CAM (3-Minute Diagnostic Interview for CAM-defined Delirium) is a standardized rapid bedside assessment for delirium screening. It evaluates four core features: (1) Acute onset/fluctuating course, (2) Inattention, (3) Disorganized thinking, and (4) Altered level of consciousness. A positive delirium diagnosis requires: Feature 1 AND Feature 2 to be present concurrently, plus at least one of Feature 3 OR Feature 4.
Measured: Postoperaitve Day 1-5
consumption of sufentanil
Measured: During the operation
Subjective sleep quality score
Using the scaleRichards-Campbell Sleep Questionnaire (RCSQ) scale. The Richards-Campbell Sleep Questionnaire (RCSQ) is a patient-reported visual analog scale assessing sleep quality in critically ill patients. It evaluates five domains: sleep depth, sleep latency (ease of falling asleep), awakenings (frequency of disruption), sleep efficiency (returning to sleep), and overall sleep quality. Patients mark each item on a 100-mm line (0 = "worst possible" to 100 = "best possible"). The total score is the mean of all domains (range: 0-100), with higher scores indicating better sleep. Administration requires ≤3 minutes and is completed by alert patients upon waking.
Measured: The first postoperative day
the use of a patient-controlled analgesia (PCA) pump
Measured: Three days after surgery
length of hospital stay
Measured: No more than 4 weeks
Patient satisfaction
Postoperative analgesia satisfaction is assessed using an 11-point Numerical Rating Scale (NRS), where 0 = "completely dissatisfied" and 10 = "completely satisfied".
Measured: From surgery to hospital discharge (up to 4 weeks).
Adverse reactions: Dizziness, nausea and vomiting
Measured: Postoperative Day 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start2 Jun 2025 (estimated)
- Primary completion13 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
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
- NCT07013721
- Sponsor's protocol ID
- PLAGH-TAPB-002
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effect of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Analgesic Efficacy in Elderly Patients Undergoing Minimally Invasive Gastrointestinal Tumor Surgery
- ClinicalTrials.gov ID
- NCT07013721
- Acronym / sponsor ID
- PLAGH-TAPB-002
- Keywords
- Regional Anaesthesia, Transversus abdominis plane block (TAP block), Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 13 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 10 Jun 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.
Elderly patients undergoing minimally invasive gastrointestinal tumor surgery face complex postoperative pain management due to age-related physiological decline and surgical particularities, where traditional opioids are prone to adverse effects. Our study investigates the clinical analgesic efficacy of ultrasound-guided transversus abdominis plane block (TAPB) in these patients, focusing on analgesic quality, delirium incidence, opioid consumption, and postoperative recovery indicators. This evaluation aims to assess its clinical value and safety while providing evidence-based insights for optimizing perioperative analgesia protocols.
Detailed description
Globally, approximately 30% of surgical patients experience moderate to severe acute postoperative pain annually, with 11% developing severe acute postoperative pain. Inadequate pain control and analgesic administration may precipitate adverse outcomes such as postoperative delirium, a complication particularly prevalent in elderly populations. The concept of multimodal analgesia has emerged to enhance therapeutic efficacy, mitigate adverse effects associated with monotherapy, accelerate postoperative rehabilitation, and improve patient satisfaction. The transversus abdominis plane block constitutes a critical component of multimodal analgesic strategies.
This randomized controlled trial was conducted to compare the differences in postoperative analgesic efficacy between the transversus abdominis plane block intervention group and the non-intervention control group among elderly patients undergoing minimally invasive gastrointestinal tumor surgery. Key evaluation parameters included postoperative pain intensity (assessed via validated pain scales), incidence of postoperative delirium, opioid consumption , and comprehensive postoperative recovery metrics (e.g., length of hospitalization). The study concurrently evaluated the clinical safety profile of transversus abdominis plane block through systematic monitoring of procedure-related complications and adverse events, thereby providing evidence-based data to refine perioperative analgesic protocols and optimize Enhanced Recovery After Surgery (ERAS) pathways in geriatric surgical populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus abdominis plane block group | Experimental | Procedure: Transversus Abdominis Plane Block, TAPBThe procedure was performed by anesthesiologists with extensive expertise in nerve blockade techniques. For upper abdominal surgical incisions, a subcostal approach transversus abdominis plane block (TAPB) was implemented under ultrasound guidance to identify the transversus abdominis plane. A total of 20 mL of 0.33% ropivacaine hydrochloride injection (Naropin®) was incrementally administered, followed by contralateral application using identical techniques, with ultrasonographic confirmation of fusiform drug distribution within the transversus abdominis plane to achieve upper abdominal incision analgesia. For lower abdominal incisions, a lateral approach was employed, with the same dosage of local anesthetic injected at the target site and bilateral blocks performed after confirming fluid dispersion patterns under real-time ultrasound visualization. |
| Non-intervention Control Group | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Elderly patients scheduled for elective minimally invasive gastrointestinal tumor surgery under general anesthesia
- Age ≥65 years
- American Society of Anesthesiologists (ASA) physical status classification ≤III
- Body mass index (BMI) 18-30 kg/m²
Key exclusion criteria (8 listed)
- Allergy to anesthetic agents
- Preoperative chronic pain or chronic use of opioids/nonsteroidal anti-inflammatory drugs (NSAIDs)
- Contraindications to regional blockade:Local infection at puncture site
- , Coagulopathy (INR >1.5, platelet count <80×10⁹/L)
- There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus Abdominis Plane Block, TAPBThe procedure was performed by anesthesiologists with extensive expertise in nerve blockade techniques. For upper abdominal surgical incisions, a subcostal approach transversus abdominis plane block (TAPB) was implemented under ultrasound guidance to identify the transversus abdominis plane. A total of 20 mL of 0.33% ropivacaine hydrochloride injection (Naropin®) was incrementally administered, followed by contralateral application using identical techniques, with ultrasonographic confirmation of fusiform drug distribution within the transversus abdominis plane to achieve upper abdominal incision analgesia. For lower abdominal incisions, a lateral approach was employed, with the same dosage of local anesthetic injected at the target site and bilateral blocks performed after confirming fluid dispersion patterns under real-time ultrasound visualization. | Procedure or surgery | transversus abdominis plane block group |
Primary outcome
Pain score
Time frame: 24 hours after surgery
Pain scores using Numerical Rating Scale (NRS). The Numerical Rating Scale (NRS) assesses pain intensity through patient self-reporting on an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Patients independently select a single number reflecting their current pain level without clinician interpretation.
8 secondary outcomes
pain score
Time frame: 1, 6, and 48 hours after surgery
postoperative delirium during hospitalization
Time frame: Postoperaitve Day 1-5
consumption of sufentanil
Time frame: During the operation
Subjective sleep quality score
Time frame: The first postoperative day
the use of a patient-controlled analgesia (PCA) pump
Time frame: Three days after surgery
length of hospital stay
Time frame: No more than 4 weeks
Patient satisfaction
Time frame: From surgery to hospital discharge (up to 4 weeks).
Adverse reactions: Dizziness, nausea and vomiting
Time frame: Postoperative Day 1-5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane Block, TAPB in people with Regional Anaesthesia and Transversus Abdominis Plane Block (TAP Block), 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 10 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain score (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.