Regional Anesthesia MorbidityLB-ESPBNCT07141667
Randomized Trial of Erector Spinae Plane Block Using Liposomal Bupivacaine Versus Bupivacaine Hydrochloride on Quality of Recovery for Video-assisted Thoracic Surgery
A study testing Erector spinae plane block with liposomal bupivacaine and Erector spinae plane block with bupivacaine HCL in people with Regional Anesthesia Morbidity and Pain, Postoperative, run by RenJi Hospital.
Trial summary
Video-assisted thoracoscopic surgery (VATS) has emerged as the standard surgical modality for pulmonary tumor. Compared with open thoracotomy, VATS is associated with reduced surgical trauma, attenuated postoperative pain, and a lower incidence of postoperative pulmonary complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Regional Anesthesia Morbidity, Pain, Postoperative
- What is being tested?
- Erector spinae plane block with liposomal bupivacaine and Erector spinae plane block with bupivacaine HCL
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Mar 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 yr of age
- ASA physical status 1 to 3
- Undergoing unilateral lung VATS under general anesthesia
- Obtaining informed consent from patients or legal representative
Who cannot join
- Unexpected convention of VATS to open thoracotomy,or unexpected post-operative admission to ICU for continued ventilation
- Unable to understand the Quality of Recovery-15 (QoR-15) and Numerical Rating Scale(NRS)
- Allergy to or contraindications for amide local anesthetics,opioids,or NSAIDs
- Long-term treatment with opioids or corticosteroids (>2 weeks)
- Drug use or substance abuse within the past 2 years
- Consuming more than 3 standard drinks per day (10g of alcohol,equivalent to 50g of Chinese high-alcohol liquor)
Show all 11Show fewer
- Pre existing dementia that may interfere with perioperative assessment
- Contraindications for nerve block,including infection or tumor at the puncture site,definitively diagnosed diabetic peripheral neuropathy
- Suffering from severe hepatic insufficiency (Child-Pugh C),or severe renal insufficiency with dialysis,or severe heart failure (METS<4)
- Pregnant or lactating women
- Previous thoracic surgeries (such an thoracic surgery or breast surgery),or preoperatively pathological pain conditions (e.g.,metastatic tumors,herpes zoster,etc)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Erector Spinae Plane Block Using Liposomal Bupivacaine Versus Bupivacaine Hydrochloride for Video-assisted Thoracic Surgery:Comparing Local Anesthetics on Quality of Recovery and Pain Score:A Randomised,Single-blind,Clinical Trial
Video-assisted thoracoscopic surgery (VATS) has emerged as the standard surgical modality for pulmonary tumor. Compared with open thoracotomy, VATS is associated with reduced surgical trauma, attenuated postoperative pain, and a lower incidence of postoperative pulmonary complications. Nevertheless, 27-63% of VATS patients still develop moderate to severe postoperative pain, with the incidence of chronic postsurgical pain (CPSP) remaining at 25-44%.
Regional analgesic techniques constitute a pivotal component of enhanced recovery after surgery (ERAS) protocols in thoracic surgery. Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been regarded as the gold-standard regional analgesic modalities for open thoracotomy. Accumulating evidence indicates that erector spinae plane block (ESPB) achieves postoperative analgesic efficacy comparable to that of PVB. In contrast to TEA, both PVB and ESPB are associated with a lower risk of complications such as hypotension, urinary retention, and epidural hematoma.
Read more
A recent randomized controlled trial comparing continuous ESPB and continuous PVB demonstrated that continuous ESPB improves the quality of postoperative recovery in VATS patients. Previous studies have also confirmed that single-injection ESPB provides superior recovery quality and analgesic efficacy compared with single-injection PVB in VATS patients. However, single-dose nerve block only exert effects for 8-12 hours, while continuous nerve blocks may increase the risk of infection and compromise patient comfort. Moderate to severe postoperative pain in VATS patients predominantly occurs within the first 48 hours postoperatively, with the most intense pain typically observed on the first postoperative day. Therefore, there is an urgent need to explore analgesic techniques with prolonged duration and fewer complications for application in VATS.
Liposomal bupivacaine, a novel extended-release local anesthetic approved by the FDA for clinical use, can prolong the duration of local anesthesia to 72 hours. Its clinical efficacy in procedures such as brachial plexus block has been validated. However, the application of liposomal bupivacaine in erector spinae plane block for VATS, and its impact on the quality of postoperative recovery, remains unreported.This study will test the hypothesis that erector spinae plane block with liposomal bupivacaine for VATS can enhance patients' quality of recovery-15 score (QoR-15) at 48 h.
Read the detailed description
This is a prospective randomized controlled trial. Patients scheduled for elective video-assisted thoracoscopic pulmonary resection will be randomly assigned to two groups: the liposomal bupivacaine group, which will undergo erector spinae plane block with liposomal bupivacaine, and the bupivacaine hydrochloride group, which will receive erector spinae plane block with bupivacaine hydrochloride. Quality of recovery-15 score (QoR-15) and other outcome measures will be observed, and our hypothesis is that erector spinae plane block with liposomal bupivacaine can enhance patients' quality of recovery-15 score (QoR-15) at 48 h.
In the anesthesia induction suite, the anesthesiologist administers an ultrasound-guided erector spinae plane (ESP) block prior to the induction of general anesthesia. The procedure involves the sequential injection of 10 mL of normal saline, followed by the administration of 0.5% bupivacaine HCL 20ml or 1.33% liposomal bupivacaine 20ml.
Postoperatively, the following analgesic protocols are administered routinely:
Basic analgesia: Parecoxib sodium (a non-steroidal anti-inflammatory drug) 40 mg, every 12 hours;Patient-controlled intravenous analgesia (PCIA): A background infusion of sufentanil at 2 μg/h, with patient-controlled analgesia (PCA) boluses of sufentanil 2 μg and a lockout period of 15 minutes;Postoperative rescue analgesia: If NRS score is ≥ 4, the attending physician will administer rescue analgesia, which will be documented in the medical record.
Safety reporting: Any unexpected complications that may arise from this trial will be documented and reported to the principal investigator and the relevant hospital patient safety board.
Sample size and justification: The primary outcome will be the QoR-15 score at 48 hours post operatively.According to published studies on quality of recovery, the minimal clinically important difference (MCID) for the QoR-15 score after surgery is 8. For major surgeries, the standard deviation (SD) of postoperative QoR-15 scores typically ranges from 10 to 16, and an SD of 12 was selected for this study. Using a two-tailed test with a significance level of α=0.05 and a test power of 1-β=0.8, the sample size calculated for each group (for comparison between the two groups) was 36 participants. With an estimated dropout rate of 10%, the final sample size was determined to be 40 participants per group, resulting in a total sample size of 80 participants.
- Conditions
- Regional Anesthesia Morbidity, Pain, Postoperative
- Being tested
- Erector spinae plane block with liposomal bupivacaine, Erector spinae plane block with bupivacaine HCL
- Keywords
- quality of recovery, erector spinae plane block, liposomal bupivacaine, video-assisted thoracic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block with liposomal bupivacaineProcedure or surgery
In the anesthesia induction suite, the anesthesiologist administers an ultrasound-guided erector spinae plane (ESP) block under local anesthesia prior to the induction of general anesthesia. The procedure involves the sequential injection of 10 mL of normal saline, followed by the administration of 20 mL of 1.33% liposomal bupivacaine.
Erector spinae plane block with bupivacaine HCLProcedure or surgery
In the anesthesia induction suite, the anesthesiologist administers an ultrasound-guided erector spinae plane (ESP) block under local anesthesia prior to the induction of general anesthesia. The procedure involves the sequential injection of 10 mL of normal saline, followed by the administration of 20 mL of 0.5% bupivacaine HCL.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine HCL Group | Active comparator | Erector spinae plane block with normal saline 10ml and bupivacaine HCL 0.5% 20ml Receives: Procedure: Erector spinae plane block with bupivacaine HCL |
| Liposomal Bupivacaine Group | Experimental | Erector spinae plane block with normal saline 10ml and liposomal bupivacaine 1.33% 20ml Receives: Procedure: Erector spinae plane block with liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery-15 score (QoR-15) at 48 h
QoR-15 is a 15-parameter questionnaire which has been recommended as an optimum tool to evaluate overall patient recovery after surgery and this includes postoperative pain. Participants will complete this questionnaire at 48 hours after their surgery. It is scored between 0 and 150, where 150 indicates that the patient has had an excellent recovery.
Measured: 48 hours postoperative
Secondary outcomes (7)
Quality of recovery-15 score (QoR-15) at 24 h
QoR-15 is a 15-parameter questionnaire which has been recommended as an optimum tool to evaluate overall patient recovery after surgery and this includes postoperative pain. Participants will complete this questionnaire at 48 hours after their surgery. It is scored between 0 and 150, where 150 indicates that the patient has had an excellent recovery.
Measured: 24 hours postoperative
Numerical Rating Scale (NRS) for pain at rest when leaving the PACU, as well as at 4 hours, 24 hours, and 48 hours postoperatively
Numerical Rating Scale pain score is measured from 0 to 10 where 0 is no pain and 10 is severe pain.
Measured: Upon discharge from the recovery room(PACU),4 hours,24 hours and 48 hours postoperative
Numerical Rating Scale (NRS) for pain during coughing when leaving the PACU, as well as at 4 hours, 24 hours, and 48 hours postoperatively
Numerical Rating Scale pain score is measured from 0 to 10 where 0 is no pain and 10 is severe pain.
Measured: Upon discharge from the recovery room(PACU),4 hours,24 hours and 48 hours postoperative
Area under the curve (AUC) of NRS for pain at rest and during coughing within 48 hours
Numerical Rating Scale pain score is measured from 0 to 10 where 0 is no pain and 10 is severe pain.
Measured: 48 hours postoperative
Cumulative consumption of opioids within 48 hours postoperatively
Dose of opioids consumed (in morphine equivalents) by participants
Measured: 48 hours postoperative
Incidence of pruritus and incidence of nausea and vomiting within 48 hours postoperatively
The incidence of postoperative pruritus is the proportion of patients who experience pruritus; the incidence of postoperative nausea and vomiting is the proportion of patients who experience nausea and vomiting.Incidence of nausea and vomiting will be defined as any nausea, emetic episodes (vomiting or retching), or both.Nausea is diagnosed when the patient has gastrointestinal symptoms but does not vomit stomach contents. Vomiting is diagnosed when the patient has gastrointestinal symptoms and retching or vomits gastric contents. Retching refers to the act of vomiting, but no stomach contents are vomited out.
Measured: 48 hours postoperative
Overall Benefit of Analgesia Score (OBAS) at 48 hours postoperatively
The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy.
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind, prospective, randomized controlled trial. Eligible patients scheduled for elective unilateral thoracic pulmonary resection will be randomly allocated to either the liposomal bupivacaine group or the bupivacaine HCL group. Patients in the liposomal bupivacaine group will undergo ultrasound-guided erector spinae plane block with liposomal bupivacaine, whereas those in the bupivacaine HCL group will receive ultrasound-guided erector spinae plane nerve block with bupivacaine hydrochloride.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141667
- Sponsor's protocol ID
- LY2025-199-A
- Acronym
- LB-ESPB
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Using Liposomal Bupivacaine Versus Bupivacaine Hydrochloride for Video-assisted Thoracic Surgery:Comparing Local Anesthetics on Quality of Recovery and Pain Score:A Randomised,Single-blind,Clinical Trial
- ClinicalTrials.gov ID
- NCT07141667
- Acronym / sponsor ID
- LB-ESPB / LY2025-199-A
- Conditions
- Regional Anesthesia Morbidity, Pain, Postoperative
- Keywords
- quality of recovery, erector spinae plane block, liposomal bupivacaine, video-assisted thoracic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Aug 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.
Video-assisted thoracoscopic surgery (VATS) has emerged as the standard surgical modality for pulmonary tumor. Compared with open thoracotomy, VATS is associated with reduced surgical trauma, attenuated postoperative pain, and a lower incidence of postoperative pulmonary complications. Nevertheless, 27-63% of VATS patients still develop moderate to severe postoperative pain, with the incidence of chronic postsurgical pain (CPSP) remaining at 25-44%.
Regional analgesic techniques constitute a pivotal component of enhanced recovery after surgery (ERAS) protocols in thoracic surgery. Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been regarded as the gold-standard regional analgesic modalities for open thoracotomy. Accumulating evidence indicates that erector spinae plane block (ESPB) achieves postoperative analgesic efficacy comparable to that of PVB. In contrast to TEA, both PVB and ESPB are associated with a lower risk of complications such as hypotension, urinary retention, and epidural hematoma.
A recent randomized controlled trial comparing continuous ESPB and continuous PVB demonstrated that continuous ESPB improves the quality of postoperative recovery in VATS patients. Previous studies have also confirmed that single-injection ESPB provides superior recovery quality and analgesic efficacy compared with single-injection PVB in VATS patients. However, single-dose nerve block only exert effects for 8-12 hours, while continuous nerve blocks may increase the risk of infection and compromise patient comfort. Moderate to severe postoperative pain in VATS patients predominantly occurs within the first 48 hours postoperatively, with the most intense pain typically observed on the first postoperative day. Therefore, there is an urgent need to explore analgesic techniques with prolonged duration and fewer complications for application in VATS.
Liposomal bupivacaine, a novel extended-release local anesthetic approved by the FDA for clinical use, can prolong the duration of local anesthesia to 72 hours. Its clinical efficacy in procedures such as brachial plexus block has been validated. However, the application of liposomal bupivacaine in erector spinae plane block for VATS, and its impact on the quality of postoperative recovery, remains unreported.This study will test the hypothesis that erector spinae plane block with liposomal bupivacaine for VATS can enhance patients' quality of recovery-15 score (QoR-15) at 48 h.
Detailed description
This is a prospective randomized controlled trial. Patients scheduled for elective video-assisted thoracoscopic pulmonary resection will be randomly assigned to two groups: the liposomal bupivacaine group, which will undergo erector spinae plane block with liposomal bupivacaine, and the bupivacaine hydrochloride group, which will receive erector spinae plane block with bupivacaine hydrochloride. Quality of recovery-15 score (QoR-15) and other outcome measures will be observed, and our hypothesis is that erector spinae plane block with liposomal bupivacaine can enhance patients' quality of recovery-15 score (QoR-15) at 48 h.
In the anesthesia induction suite, the anesthesiologist administers an ultrasound-guided erector spinae plane (ESP) block prior to the induction of general anesthesia. The procedure involves the sequential injection of 10 mL of normal saline, followed by the administration of 0.5% bupivacaine HCL 20ml or 1.33% liposomal bupivacaine 20ml.
Postoperatively, the following analgesic protocols are administered routinely:
Basic analgesia: Parecoxib sodium (a non-steroidal anti-inflammatory drug) 40 mg, every 12 hours;Patient-controlled intravenous analgesia (PCIA): A background infusion of sufentanil at 2 μg/h, with patient-controlled analgesia (PCA) boluses of sufentanil 2 μg and a lockout period of 15 minutes;Postoperative rescue analgesia: If NRS score is ≥ 4, the attending physician will administer rescue analgesia, which will be documented in the medical record.
Safety reporting: Any unexpected complications that may arise from this trial will be documented and reported to the principal investigator and the relevant hospital patient safety board.
Sample size and justification: The primary outcome will be the QoR-15 score at 48 hours post operatively.According to published studies on quality of recovery, the minimal clinically important difference (MCID) for the QoR-15 score after surgery is 8. For major surgeries, the standard deviation (SD) of postoperative QoR-15 scores typically ranges from 10 to 16, and an SD of 12 was selected for this study. Using a two-tailed test with a significance level of α=0.05 and a test power of 1-β=0.8, the sample size calculated for each group (for comparison between the two groups) was 36 participants. With an estimated dropout rate of 10%, the final sample size was determined to be 40 participants per group, resulting in a total sample size of 80 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blind, prospective, randomized controlled trial. Eligible patients scheduled for elective unilateral thoracic pulmonary resection will be randomly allocated to either the liposomal bupivacaine group or the bupivacaine HCL group. Patients in the liposomal bupivacaine group will undergo ultrasound-guided erector spinae plane block with liposomal bupivacaine, whereas those in the bupivacaine HCL group will receive ultrasound-guided erector spinae plane nerve block with bupivacaine hydrochloride.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine HCL Group | Active comparator | Procedure: Erector spinae plane block with bupivacaine HCLErector spinae plane block with normal saline 10ml and bupivacaine HCL 0.5% 20ml |
| Liposomal Bupivacaine Group | Experimental | Procedure: Erector spinae plane block with liposomal bupivacaineErector spinae plane block with normal saline 10ml and liposomal bupivacaine 1.33% 20ml |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 yr of age
- ASA physical status 1 to 3
- Undergoing unilateral lung VATS under general anesthesia
- Obtaining informed consent from patients or legal representative
Key exclusion criteria (11 listed)
- Unexpected convention of VATS to open thoracotomy,or unexpected post-operative admission to ICU for continued ventilation
- Unable to understand the Quality of Recovery-15 (QoR-15) and Numerical Rating Scale(NRS)
- Allergy to or contraindications for amide local anesthetics,opioids,or NSAIDs
- Long-term treatment with opioids or corticosteroids (>2 weeks)
- Drug use or substance abuse within the past 2 years
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 |
|---|---|---|
| Erector spinae plane block with liposomal bupivacaineIn the anesthesia induction suite, the anesthesiologist administers an ultrasound-guided erector spinae plane (ESP) block under local anesthesia prior to the induction of general anesthesia. The procedure involves the sequential injection of 10 mL of normal saline, followed by the administration of 20 mL of 1.33% liposomal bupivacaine. | Procedure or surgery | Liposomal Bupivacaine Group |
| Erector spinae plane block with bupivacaine HCLIn the anesthesia induction suite, the anesthesiologist administers an ultrasound-guided erector spinae plane (ESP) block under local anesthesia prior to the induction of general anesthesia. The procedure involves the sequential injection of 10 mL of normal saline, followed by the administration of 20 mL of 0.5% bupivacaine HCL. | Procedure or surgery | Bupivacaine HCL Group |
Primary outcome
Quality of recovery-15 score (QoR-15) at 48 h
Time frame: 48 hours postoperative
QoR-15 is a 15-parameter questionnaire which has been recommended as an optimum tool to evaluate overall patient recovery after surgery and this includes postoperative pain. Participants will complete this questionnaire at 48 hours after their surgery. It is scored between 0 and 150, where 150 indicates that the patient has had an excellent recovery.
7 secondary outcomes
Quality of recovery-15 score (QoR-15) at 24 h
Time frame: 24 hours postoperative
Numerical Rating Scale (NRS) for pain at rest when leaving the PACU, as well as at 4 hours, 24 hours, and 48 hours postoperatively
Time frame: Upon discharge from the recovery room(PACU),4 hours,24 hours and 48 hours postoperative
Numerical Rating Scale (NRS) for pain during coughing when leaving the PACU, as well as at 4 hours, 24 hours, and 48 hours postoperatively
Time frame: Upon discharge from the recovery room(PACU),4 hours,24 hours and 48 hours postoperative
Area under the curve (AUC) of NRS for pain at rest and during coughing within 48 hours
Time frame: 48 hours postoperative
Cumulative consumption of opioids within 48 hours postoperatively
Time frame: 48 hours postoperative
Incidence of pruritus and incidence of nausea and vomiting within 48 hours postoperatively
Time frame: 48 hours postoperative
Overall Benefit of Analgesia Score (OBAS) at 48 hours postoperatively
Time frame: 48 hours postoperative
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 26 Aug 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block with liposomal bupivacaine and Erector spinae plane block with bupivacaine HCL in people with Regional Anesthesia Morbidity and Pain, Postoperative, run by RenJi 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 11 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 26 Aug 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?
Contact zhisheng Lu (+8618916951095, luzhisheng@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery-15 score (QoR-15) at 48 h (time frame: 48 hours postoperative). 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 26 Aug 2025.