Thoracic SurgeryNCT06392191
Comparison of Bupivacaine Liposomal vs Bupivacaine Combined With Dexamethasone for Postoperative Pain in VATS
A study testing Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml) and Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.) in people with Thoracic Surgery, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial summary
The purpose of this study, is to investigate the effectiveness of ultrasound-guided rhombic intercostal nerve block for postoperative pain control in thoracoscopic pulmonary resection with bupivacaine liposomes versus bupivacaine hydrochloride with dexamethasone to assess whether bupivacaine liposomes will produce… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml) and Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2024to 2 May 2025
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA physical status I-III, aged between 18 and 80 years, scheduled for elective thoracoscopic lung resection surgery under general anesthesia with endotracheal intubation (including wedge resection, segmentectomy, or lobectomy) with one or three incisions, expected duration of surgery less than 4 hours, and body mass index (BMI) between 18 and 30 kg/m².
Who cannot join
- trauma or emergency patients;
- patients classified as New York Heart Association (NYHA) functional class 3-4;
- unstable coronary artery disease patients;
- patients with renal system diseases (estimated glomerular filtration rate <30 mL/min/1.73 m²);
- patients with liver system diseases (alanine aminotransferase or aspartate aminotransferase levels exceeding twice the normal value);
- patients with coagulation disorders, or those who have not discontinued warfarin or novel anticoagulants (such as rivaroxaban, dabigatran) prior to surgery;
Show all 12Show fewer
- individuals with a history of alcohol abuse or substance dependence within the past two months;
- patients with uncontrolled anxiety, schizophrenia, or other psychiatric disorders;
- pregnant or planning to become pregnant women;
- individuals with a history of allergy to local anesthetics or investigational drugs. Additionally, patients who refuse to sign the informed consent form will also be excluded;
- chronic pain syndromes (defined as reflex sympathetic dystrophy or complex regional pain syndrome);
- chronic opioid use (longer than 3 months or daily morphine equivalents more than 5 mg/day for 1 month).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Liposomal Bupivacaine Combined With Bupivacaine and Dexamethasone for Rhomboid Intercostal Block on Postoperative Pain Following Video-Assisted Thoracoscopic Surgery: A Non-inferiority, Double-blind, Randomized Trial.
The purpose of this study, is to investigate the effectiveness of ultrasound-guided rhombic intercostal nerve block for postoperative pain control in thoracoscopic pulmonary resection with bupivacaine liposomes versus bupivacaine hydrochloride with dexamethasone to assess whether bupivacaine liposomes will produce analgesia superior to bupivacaine hydrochloride with dexamethasone in terms of analgesia effect and duration of analgesia. This study will also evaluate whether liposomal bupivacaine after nerve block improves the quality of postoperative recovery compared to bupivacaine hydrochloride combined with dexamethasone.
Read the detailed description
Approved by the Ethics Committee of Jiaxing No. 1 Hospital (approval number: 2024-KY-226). This study was enrolled prior to patient enrollment in the clinical trial. Written informed consent was obtained from all participants. The study is expected to be conducted from April 2024 through December 2025. This study enrolls 90 elective thoracoscopic lung resection surgery(including wedge resection, segmentectomy, or lobectomy) patients between the ages of 18-80 years, ASA Physical Status I and III, who had no allergic reaction to the study drug.
Basic monitoring such as electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. The bupivacaine liposome group was treated with bupivacaine liposome 93 mg combined with bupivacaine 25 mg, and the standard control group was treated with bupivacaine hydrochloride 105 mg combined with dexamethasone 5 mg, and both groups were perfused with saline 20 ml. ultrasound-guided rhombic intercostal muscle nerve block was performed for a total of 20 ml. postoperative analgesia was provided using patient-controlled intravenous analgesia (PCIA), and according to the patients weight and baseline condition. Upon arrival of postoperative patients to the ward, if the patient reports significant pain, defined as the numeric rating scale (NRS), score greater than 3, the first step is to administer one press of the analgesic pump. If the pain persists, the pain management protocol will be initiated. Cumulative PCIA consumption at different postoperative time intervals (including 0-24 hours, 24-48 hours, and 48-72 hours). Quality of Recovery Score (QoR-15) at 72 hours postoperatively, If NRS at 6 hours to 3 months, and patient satisfaction were recorded.Pain assessments were performed at the following time points: 0 hours postoperatively (upon tracheal extubation and patient awakening), 0.5 hours, 2 hours, 4 hours, 12 hours, 24 hours, 48 hours, and 72 hours. Pain score follow-up by telephone at the third month.
- Conditions
- Thoracic Surgery
- Being tested
- Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml), Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.)
- Keywords
- Rhombic intercostal nerve block, thoracoscopy, Bupivacaine liposomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml)Procedure or surgery
The patient was placed in lateral recumbency and placed medial to the medial border of the scapula in the oblique sagittal plane using a line array ultrasound probe to identify ultrasound landmarks, trapezius, obliques, intercostals, pleura, and lungs, The block needle was then entered in-plane at the T5 level, with the margins retracting on insertion, and the nerve block perforating needle was imaged and then inserted into the fascial gap between the trapezius and the external intercostal muscles. Receive liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20ml.
Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.)Procedure or surgery
The patient was placed in lateral recumbency and placed medial to the medial border of the scapula in the oblique sagittal plane using a line array ultrasound probe to identify ultrasound landmarks, trapezius, obliques, intercostals, pleura, and lungs, The block needle was then entered in-plane at the T5 level, with the margins retracting on insertion, and the nerve block perforating needle was imaged and then inserted into the fascial gap between the trapezius and the external intercostal muscles. A mixture of standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg was received.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine liposomes group | Other | The nerve block puncture needle was imaged and then entered into the fascial space between the rhomboid and extracostal muscles, and liposomal bupivacaine 93 mg and bupivacaine 25mg diluted to 20 ml were injected into this space. Receives: Procedure: Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml) |
| Standard bupivacaine dexamethasone group | Other | The nerve block puncture needle was imaged and then entered into the fascial space between the rhomboid and external intercostal muscles, and a mixture of: receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg was injected into this space. Receives: Procedure: Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
Area under the curve of the numeric rating scale (NRS) scores at rest
Measured: 0-48 hours after surgery
Secondary outcomes (17)
Change in functional pain using Brief Pain Inventory (BPI)
Compare functional pain using the BPI at baseline, 6 weeks and 3 months. The BPI scale defines pain as follows: Score: 1 - 4 = Mild Pain, Score: 5 - 6 = Moderate Pain, Score: 7 - 10 = Severe Pain.
Measured: Preoperative day one, 6 weeks after surgery, 3 months after surgery
Change in Quality of Recovery 15 questionnaire
15 questions assessing the quality of recovery, rated on a ten-point scale with a total score ranging from 0 (very poor recovery) to 150 (good recovery)
Measured: Preoperative day one；Day 1, 2 and 7 after surgery
Change in white blood cell count (WBC)
Compare the change in postoperative WBC from baseline only for participants that have an overnight hospital stay
Measured: Preoperative day one, day 0, day 1 and day 2 after surgery
Length of hospital stay
The patient post surgical length of stay in the hospital will be compared between treatment groups.
Measured: perioperatively
Absolute value of Interleukin 1 beta (IL-1b)
Absolute value IL-1b at postoperative day 1 only for participants that have an overnight hospital stay
Measured: day 1 after surgery
CD3、CD4、CD4/CD8 and CD16+56
Postoperative day 1 CD3, CD4, CD4/CD8 and CD16+56 only for participants who were hospitalised overnight and pathologically had lung cancer
Measured: Preoperative day one，day 1 after surgery
Absolute value of Interleukin 6 (IL-6)
Absolute value IL-6 at postoperative day 1 only for participants that have an overnight hospital stay
Measured: day 1 after surgery
C-reactive protein (CRP)
Absolute value C-reactive protein at postoperative day 1 only for participants that have an overnight hospital stay
Measured: day 1 after surgery
Postoperative chest Pain Score
Average postoperative chest pain scores for the first two postoperative days using numerical rating scale (NRS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).
Measured: Preoperative day one；Day 1 after surgery; Day 2 after surgery; Day 3 after surgery
postoperative complications
Postoperative complications include arrhythmia, bowel obstruction, atrial fibrillation, and other cardiorespiratory systems.
Measured: perioperatively
mean arterial pressure
Changes in haemodynamics during surgery
Measured: Start of surgery to end of surgery
systolic blood pressure
Changes in haemodynamics during surgery
Measured: Start of surgery to end of surgery
diastolic blood pressure
Changes in haemodynamics during surgery
Measured: Start of surgery to end of surgery
heart rate
Changes in haemodynamics during surgery
Measured: Start of surgery to end of surgery
liver function
Transaminases in biochemical indicators
Measured: perioperatively
kidney function
Creatinine in biochemical indicators
Measured: perioperatively
Incidence of remedial analgesia
Remedial analgesia was given when the patient's numerical analogue score (NRS) was greater than 3 in the postoperative period
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start10 Nov 2024
- Primary completion1 Apr 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
- Investigators
- QINGhe ZHOU, professor, Principal investigator, deputy chair of board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392191
- Sponsor's protocol ID
- 2024-KY-226
- Status last verified
- Jun 2025
- First submitted
- 8 Apr 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie Y, Yan D, Shen J. Video-assisted thoracic surgery versus thoracotomy for treatment of patients with pulmonary sequestration: A systematic review and meta-analysis. Asian J Surg. 2023 Aug;46(8):3387-3388. doi: 10.1016/j.asjsur.2023.03.097. Epub 2023 Mar 25. No abstract available.
PubMed 36973139Elsharkawy H, Ince I, Pawa A. Rhomboid intercostal and sub-serratus (RISS) plane block for analgesia after lung transplant. J Clin Anesth. 2019 Sep;56:85-87. doi: 10.1016/j.jclinane.2019.01.042. Epub 2019 Jan 28. No abstract available.
PubMed 30703673Xie L, Xi Y, He X, An M, Jia X, Li Z, Chen T, Zhou Q. Liposomal Bupivacaine vs. Plain Bupivacaine with Dexamethasone for Rhomboid Intercostal Block in the Management of Postoperative Pain After Video-Assisted Thoracoscopic Surgery: A Randomized Non-inferiority Trial. Pain Ther. 2025 Oct;14(5):1513-1530. doi: 10.1007/s40122-025-00763-1. Epub 2025 Aug 4.
PubMed 40758210
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liposomal Bupivacaine Combined With Bupivacaine and Dexamethasone for Rhomboid Intercostal Block on Postoperative Pain Following Video-Assisted Thoracoscopic Surgery: A Non-inferiority, Double-blind, Randomized Trial.
- ClinicalTrials.gov ID
- NCT06392191
- Acronym / sponsor ID
- 2024-KY-226
- Conditions
- Thoracic Surgery
- Keywords
- Rhombic intercostal nerve block, thoracoscopy, Bupivacaine liposomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 30 Apr 2024 (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.
The purpose of this study, is to investigate the effectiveness of ultrasound-guided rhombic intercostal nerve block for postoperative pain control in thoracoscopic pulmonary resection with bupivacaine liposomes versus bupivacaine hydrochloride with dexamethasone to assess whether bupivacaine liposomes will produce analgesia superior to bupivacaine hydrochloride with dexamethasone in terms of analgesia effect and duration of analgesia. This study will also evaluate whether liposomal bupivacaine after nerve block improves the quality of postoperative recovery compared to bupivacaine hydrochloride combined with dexamethasone.
Detailed description
Approved by the Ethics Committee of Jiaxing No. 1 Hospital (approval number: 2024-KY-226). This study was enrolled prior to patient enrollment in the clinical trial. Written informed consent was obtained from all participants. The study is expected to be conducted from April 2024 through December 2025. This study enrolls 90 elective thoracoscopic lung resection surgery(including wedge resection, segmentectomy, or lobectomy) patients between the ages of 18-80 years, ASA Physical Status I and III, who had no allergic reaction to the study drug.
Basic monitoring such as electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. The bupivacaine liposome group was treated with bupivacaine liposome 93 mg combined with bupivacaine 25 mg, and the standard control group was treated with bupivacaine hydrochloride 105 mg combined with dexamethasone 5 mg, and both groups were perfused with saline 20 ml. ultrasound-guided rhombic intercostal muscle nerve block was performed for a total of 20 ml. postoperative analgesia was provided using patient-controlled intravenous analgesia (PCIA), and according to the patients weight and baseline condition. Upon arrival of postoperative patients to the ward, if the patient reports significant pain, defined as the numeric rating scale (NRS), score greater than 3, the first step is to administer one press of the analgesic pump. If the pain persists, the pain management protocol will be initiated. Cumulative PCIA consumption at different postoperative time intervals (including 0-24 hours, 24-48 hours, and 48-72 hours). Quality of Recovery Score (QoR-15) at 72 hours postoperatively, If NRS at 6 hours to 3 months, and patient satisfaction were recorded.Pain assessments were performed at the following time points: 0 hours postoperatively (upon tracheal extubation and patient awakening), 0.5 hours, 2 hours, 4 hours, 12 hours, 24 hours, 48 hours, and 72 hours. Pain score follow-up by telephone at the third month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine liposomes group | Other | Procedure: Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml)The nerve block puncture needle was imaged and then entered into the fascial space between the rhomboid and extracostal muscles, and liposomal bupivacaine 93 mg and bupivacaine 25mg diluted to 20 ml were injected into this space. |
| Standard bupivacaine dexamethasone group | Other | Procedure: Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.)The nerve block puncture needle was imaged and then entered into the fascial space between the rhomboid and external intercostal muscles, and a mixture of: receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg was injected into this space. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-III, aged between 18 and 80 years, scheduled for elective thoracoscopic lung resection surgery under general anesthesia with endotracheal intubation (including wedge resection, segmentectomy, or lobectomy) with one or three incisions, expected duration of surgery less than 4 hours, and body mass index (BMI) between 18 and 30 kg/m².
Key exclusion criteria (12 listed)
- trauma or emergency patients;
- patients classified as New York Heart Association (NYHA) functional class 3-4;
- unstable coronary artery disease patients;
- patients with renal system diseases (estimated glomerular filtration rate <30 mL/min/1.73 m²);
- patients with liver system diseases (alanine aminotransferase or aspartate aminotransferase levels exceeding twice the normal value);
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 |
|---|---|---|
| Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml)The patient was placed in lateral recumbency and placed medial to the medial border of the scapula in the oblique sagittal plane using a line array ultrasound probe to identify ultrasound landmarks, trapezius, obliques, intercostals, pleura, and lungs, The block needle was then entered in-plane at the T5 level, with the margins retracting on insertion, and the nerve block perforating needle was imaged and then inserted into the fascial gap between the trapezius and the external intercostal muscles. Receive liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20ml. | Procedure or surgery | Bupivacaine liposomes group |
| Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.)The patient was placed in lateral recumbency and placed medial to the medial border of the scapula in the oblique sagittal plane using a line array ultrasound probe to identify ultrasound landmarks, trapezius, obliques, intercostals, pleura, and lungs, The block needle was then entered in-plane at the T5 level, with the margins retracting on insertion, and the nerve block perforating needle was imaged and then inserted into the fascial gap between the trapezius and the external intercostal muscles. A mixture of standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg was received. | Procedure or surgery | Standard bupivacaine dexamethasone group |
Primary outcome
Area under the curve
Time frame: 0-48 hours after surgery
Area under the curve of the numeric rating scale (NRS) scores at rest
17 secondary outcomes
Change in functional pain using Brief Pain Inventory (BPI)
Time frame: Preoperative day one, 6 weeks after surgery, 3 months after surgery
Change in Quality of Recovery 15 questionnaire
Time frame: Preoperative day one；Day 1, 2 and 7 after surgery
Change in white blood cell count (WBC)
Time frame: Preoperative day one, day 0, day 1 and day 2 after surgery
Length of hospital stay
Time frame: perioperatively
Absolute value of Interleukin 1 beta (IL-1b)
Time frame: day 1 after surgery
CD3、CD4、CD4/CD8 and CD16+56
Time frame: Preoperative day one，day 1 after surgery
Absolute value of Interleukin 6 (IL-6)
Time frame: day 1 after surgery
C-reactive protein (CRP)
Time frame: day 1 after surgery
Postoperative chest Pain Score
Time frame: Preoperative day one；Day 1 after surgery; Day 2 after surgery; Day 3 after surgery
postoperative complications
Time frame: perioperatively
mean arterial pressure
Time frame: Start of surgery to end of surgery
systolic blood pressure
Time frame: Start of surgery to end of surgery
diastolic blood pressure
Time frame: Start of surgery to end of surgery
heart rate
Time frame: Start of surgery to end of surgery
liver function
Time frame: perioperatively
kidney function
Time frame: perioperatively
Incidence of remedial analgesia
Time frame: perioperatively
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 1 Jul 2025.
- Results publication: PubMed 36973139Xie Y, Yan D, Shen J. Video-assisted thoracic surgery versus thoracotomy for treatment of patients with pulmonary sequestration: A systematic review and meta-analysis. Asian J Surg. 2023 Aug;46(8):3387-3388. doi: 10.1016/j.asjsur.2023.03.097. Epub 2023 Mar 25. No abstract available.
- Results publication: PubMed 30703673Elsharkawy H, Ince I, Pawa A. Rhomboid intercostal and sub-serratus (RISS) plane block for analgesia after lung transplant. J Clin Anesth. 2019 Sep;56:85-87. doi: 10.1016/j.jclinane.2019.01.042. Epub 2019 Jan 28. No abstract available.
- Derived from this study: PubMed 40758210Xie L, Xi Y, He X, An M, Jia X, Li Z, Chen T, Zhou Q. Liposomal Bupivacaine vs. Plain Bupivacaine with Dexamethasone for Rhomboid Intercostal Block in the Management of Postoperative Pain After Video-Assisted Thoracoscopic Surgery: A Randomized Non-inferiority Trial. Pain Ther. 2025 Oct;14(5):1513-1530. doi: 10.1007/s40122-025-00763-1. Epub 2025 Aug 4.
- 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.
QINGhe ZHOU, professor principal investigator
deputy chair of board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml) and Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.) in people with Thoracic Surgery, run by Affiliated Hospital of Jiaxing University at 1 site in China.
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 1 inclusion and 12 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Area under the curve (time frame: 0-48 hours after surgery). 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 NCT06392191, which also lists 3 linked publications.
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 1 Jul 2025.