Laparoscopic SurgeryNCT07458282
The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery
A study testing Bupivacaine hydrochloride and Liposomal bupivacaine plus bupivacaine in people with Laparoscopic Surgery and Liposomal Bupivacaine, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Laparoscopic surgery has become the preferred approach for abdominal surgical interventions due to its advantages of minimal invasiveness, rapid recovery, and reduced complication rates. Despite its minimally invasive nature, postoperative pain persists and adversely affects patient recovery. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Laparoscopic Surgery, Liposomal Bupivacaine, Transversus Abdominis Plane Block
- What is being tested?
- Bupivacaine hydrochloride and Liposomal bupivacaine plus bupivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 30 Jun 2027
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for elective laparoscopic cholecystectomy, hernia repair, and appendectomy under general anesthesia;
- Ages 18 to 64 years old；
- American Society of Anesthesiologists (ASA) physical status of I-III；
- Glasgow Coma Scale (GCS) score of 15；
- Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.
Who cannot join
- History of chronic pain syndrome of any cause.
- Patients with heart conduction block (sinus block or atrioventricular block).
- Patients with unstable coronary artery disease.
- Patients with gastric ulcer or gastric bleeding.
- Patients with diabetes and are being treated with insulin.
- Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran.
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- Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN.
- Patients with renal impairment (serum creatinine > 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.
- Patients with a history of diagnosed mental illness or currently taking psychotropic medication.
- Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery.
- Pregnancy or breastfeeding.
- Extreme body mass index (BMI) (< 15 or > 35).
- Participation in another interventional trial that interferes with the intervention or outcome of this trial.
- Patients with a history of allergy to local anaesthetics or one of the study drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Fang Luo, +86 13611326978, 13611326978@163.com
About this study
Official title: The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Transversus Abdominis Plane Block for Postoperative Pain in Patients Undergoing Laparoscopic Surgery:A Multi-Center Randomized Controlled Trial
Laparoscopic surgery has become the preferred approach for abdominal surgical interventions due to its advantages of minimal invasiveness, rapid recovery, and reduced complication rates. Despite its minimally invasive nature, postoperative pain persists and adversely affects patient recovery. In the absence of effective pain management, acute pain may progress to chronic pain. Although opioids provide reliable analgesic effects, their associated adverse reactions limit their application following minimally invasive procedures. Regional analgesia serves as the cornerstone of multimodal analgesia, and ultrasound-guided nerve block techniques have become increasingly refined. Ultrasound-guided transversus abdominis plane block(TAPB) generally fulfills intraoperative and postoperative analgesic requirements for laparoscopic surgeries by inhibiting the transmission of nociceptive stimuli in the targeted region, thereby aiding in the prevention of central sensitization. Conventional TAPB utilize local anesthetics, which demonstrate excellent efficacy in alleviating incisional pain. However, the short duration of analgesia provided by conventional local anesthetics significantly compromises their clinical utility.Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours.However, its efficacy and safety in laparoscopic surgery not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of Ultrasound-guided TAPB utilizing liposomal bupivacaine plus bupivacaine for postoperative pain management in patients undergoing laparoscopic surgery.
- Being tested
- Bupivacaine hydrochloride, Liposomal bupivacaine plus bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine hydrochlorideDrug
Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, with 20 mL of 0.25% bupivacaine administered per side. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen(containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
Liposomal bupivacaine plus bupivacaineDrug
Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, 20 mL (266 mg) of liposomal bupivacaine will be mixed with 20 mL of 0.25% bupivacaine hydrochloride (50 mg, diluted in normal saline) to prepare a 40 mL solution. A volume of 20 mL will be administered to each side.The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine hydrochloride | Active comparator | Not described Receives: Drug: Bupivacaine hydrochloride |
| Liposomal bupivacaine plus bupivacaine | Experimental | Not described Receives: Drug: Liposomal bupivacaine plus bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Measured: The postoperative period 48 hours.
Secondary outcomes (17)
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Measured: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Measured: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Measured: Postoperative day 7, month 1, and month 3.
Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Measured: Postoperative day 7, month 1, and month 3.
Time to request of first analgesia
Measured: Within 48 hours postoperatively.
Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses
Measured: Postoperative Hours 4, 8, 24, and 48.
Duration days of Oral Oxycodone and Acetaminophen Tablets Administration
Measured: Within 3 months postoperatively.
Total dosage of orally oxycodone and acetaminophen tablets
Measured: Within 3 months postoperatively.
Intraoperative Anesthetic Dosage
Measured: During the surgical anesthesia phase.
Patient Satisfaction Scale，PSS
Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied."
Measured: Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.
Ramsay Sedation Scale，RSS
The RSS utilizes a six-point scale to evaluate sedation levels. The total score ranges from 1 to 6 as follows: anxious or agitated (1 point); oriented, calm, and cooperative (2 points); responsive to commands (3 points); drowsy with brisk response to glabellar tap or loud auditory stimulus (4 points); drowsy with sluggish response to glabellar tap or loud auditory stimulus (5 points)；and drowsy with no response whatsoever（6）points. A score of 1 reflects inadequate sedation, scores of 2 to 4 indicate satisfactory sedation, while scores of 5 to 6 denote oversedation.
Measured: Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.
Quality of Recovery-40，QoR-40
The Quality of Recovery-40 (QoR-40) serves as a globally recognized metric for evaluating the quality of recovery. It encompasses five dimensions-emotional state, physical comfort, physiological independence, psychological support, and pain-comprising a total of 40 items, each rated on a 1-5 scoring scale. The overall QoR-40 score ranges from 40 (indicating extremely poor recovery quality) to 200 (representing excellent recovery quality).
Measured: Postoperative hours 24, 48, and 72.
The duration of stay in the post-anesthesia care unit（PACU）
The time from the end of surgery until the patient regains consciousness and has stable vital signs after extubating and is subsequently transferred back to the ward.
Measured: The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute.
Length of Stay (LOS)
Measured: Perioperation.
Total hospitalization expenses incurred during the patient's inpatient stay
Measured: Perioperation.
Postoperative nausea and vomiting，PONV
Measured: Postoperatively within 72 hours.
Adverse events，AEs
Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl.
Measured: Within 72 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start10 Mar 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458282
- Sponsor's protocol ID
- KY2025-289-02-5
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Publications
Suseela I, Anandan K, Aravind A, Kaniyil S. Comparison of ultrasound-guided bilateral subcostal transversus abdominis plane block and port-site infiltration with bupivacaine in laparoscopic cholecystectomy. Indian J Anaesth. 2018 Jul;62(7):497-501. doi: 10.4103/ija.IJA_55_18.
PubMed 30078851Waddimba AC, Newman P, Shelley JK, McShan EE, Cheung ZO, Gibson JN, Bennett MM, Petrey LB. Pain management after laparoscopic appendectomy: Comparative effectiveness of innovative pre-emptive analgesia using liposomal bupivacaine. Am J Surg. 2022 May;223(5):832-838. doi: 10.1016/j.amjsurg.2021.09.019. Epub 2021 Sep 24.
PubMed 34610868
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Transversus Abdominis Plane Block for Postoperative Pain in Patients Undergoing Laparoscopic Surgery:A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07458282
- Acronym / sponsor ID
- KY2025-289-02-5
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Mar 2026 (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.
Laparoscopic surgery has become the preferred approach for abdominal surgical interventions due to its advantages of minimal invasiveness, rapid recovery, and reduced complication rates. Despite its minimally invasive nature, postoperative pain persists and adversely affects patient recovery. In the absence of effective pain management, acute pain may progress to chronic pain. Although opioids provide reliable analgesic effects, their associated adverse reactions limit their application following minimally invasive procedures. Regional analgesia serves as the cornerstone of multimodal analgesia, and ultrasound-guided nerve block techniques have become increasingly refined. Ultrasound-guided transversus abdominis plane block(TAPB) generally fulfills intraoperative and postoperative analgesic requirements for laparoscopic surgeries by inhibiting the transmission of nociceptive stimuli in the targeted region, thereby aiding in the prevention of central sensitization. Conventional TAPB utilize local anesthetics, which demonstrate excellent efficacy in alleviating incisional pain. However, the short duration of analgesia provided by conventional local anesthetics significantly compromises their clinical utility.Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours.However, its efficacy and safety in laparoscopic surgery not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of Ultrasound-guided TAPB utilizing liposomal bupivacaine plus bupivacaine for postoperative pain management in patients undergoing laparoscopic surgery.
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 |
|---|---|---|
| Bupivacaine hydrochloride | Active comparator | Drug: Bupivacaine hydrochloride |
| Liposomal bupivacaine plus bupivacaine | Experimental | Drug: Liposomal bupivacaine plus bupivacaine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective laparoscopic cholecystectomy, hernia repair, and appendectomy under general anesthesia;
- Ages 18 to 64 years old；
- American Society of Anesthesiologists (ASA) physical status of I-III；
- Glasgow Coma Scale (GCS) score of 15；
- Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.
Key exclusion criteria (14 listed)
- History of chronic pain syndrome of any cause.
- Patients with heart conduction block (sinus block or atrioventricular block).
- Patients with unstable coronary artery disease.
- Patients with gastric ulcer or gastric bleeding.
- Patients with diabetes and are being treated with insulin.
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 |
|---|---|---|
| Bupivacaine hydrochloridePrior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, with 20 mL of 0.25% bupivacaine administered per side. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen(containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours. | Drug | Bupivacaine hydrochloride |
| Liposomal bupivacaine plus bupivacainePrior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, 20 mL (266 mg) of liposomal bupivacaine will be mixed with 20 mL of 0.25% bupivacaine hydrochloride (50 mg, diluted in normal saline) to prepare a 40 mL solution. A volume of 20 mL will be administered to each side.The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours. | Drug | Liposomal bupivacaine plus bupivacaine |
Primary outcome
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Time frame: The postoperative period 48 hours.
17 secondary outcomes
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
Time frame: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
Time frame: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively
Time frame: Postoperative day 7, month 1, and month 3.
Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively
Time frame: Postoperative day 7, month 1, and month 3.
Time to request of first analgesia
Time frame: Within 48 hours postoperatively.
Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses
Time frame: Postoperative Hours 4, 8, 24, and 48.
Duration days of Oral Oxycodone and Acetaminophen Tablets Administration
Time frame: Within 3 months postoperatively.
Total dosage of orally oxycodone and acetaminophen tablets
Time frame: Within 3 months postoperatively.
Intraoperative Anesthetic Dosage
Time frame: During the surgical anesthesia phase.
Patient Satisfaction Scale，PSS
Time frame: Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.
Ramsay Sedation Scale，RSS
Time frame: Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.
Quality of Recovery-40，QoR-40
Time frame: Postoperative hours 24, 48, and 72.
The duration of stay in the post-anesthesia care unit（PACU）
Time frame: The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute.
Length of Stay (LOS)
Time frame: Perioperation.
Total hospitalization expenses incurred during the patient's inpatient stay
Time frame: Perioperation.
Postoperative nausea and vomiting，PONV
Time frame: Postoperatively within 72 hours.
Adverse events，AEs
Time frame: Within 72 hours postoperatively.
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 17 Mar 2026.
- Background: PubMed 30078851Suseela I, Anandan K, Aravind A, Kaniyil S. Comparison of ultrasound-guided bilateral subcostal transversus abdominis plane block and port-site infiltration with bupivacaine in laparoscopic cholecystectomy. Indian J Anaesth. 2018 Jul;62(7):497-501. doi: 10.4103/ija.IJA_55_18.
- Background: PubMed 34610868Waddimba AC, Newman P, Shelley JK, McShan EE, Cheung ZO, Gibson JN, Bennett MM, Petrey LB. Pain management after laparoscopic appendectomy: Comparative effectiveness of innovative pre-emptive analgesia using liposomal bupivacaine. Am J Surg. 2022 May;223(5):832-838. doi: 10.1016/j.amjsurg.2021.09.019. Epub 2021 Sep 24.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine hydrochloride and Liposomal bupivacaine plus bupivacaine in people with Laparoscopic Surgery and Liposomal Bupivacaine, run by Beijing Tiantan Hospital 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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?
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?
Contact Fang Luo (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively (time frame: The postoperative period 48 hours.). 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 NCT07458282, which also lists 2 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 17 Mar 2026.