Femoral Neck FracturesPhase 4PENGNCT06565910
Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)
A Phase 4 study testing Liposomal bupivacaine plus bupivacaine and Ropivacaine in people with Femoral Neck Fractures and Femur Head Necrosis, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoral Neck Fractures, Femur Head Necrosis, Hip Fractures
- What is being tested?
- Liposomal bupivacaine plus bupivacaine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2024to 1 Jul 2026
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists(ASA) I~II
- Normal coagulation
- Clinical diagnosis of hip fracture
Who cannot join
- Presence of severe systemic diseases or ASA grade III or higher
- Allergy to amide local anesthetics
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
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST
Wuhan, Hubei, 430030
Xijian Ke, MD, 13429826148, kexijian@hust.edu.cn
Xijian KE, MD
About this study
Official title: Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for PENG Block on Post Operative Pain Management in Patients Undergoing Hip Arthroplasty: a Prospective, Randomized, Single Blind, Active Controlled Study
The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are:
- Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction?
- What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery?
Read more
Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery.
Participants will:
- Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance.
- Undergo hip replacement surgery under spinal anesthesia.
- Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.
- Conditions
- Femoral Neck Fractures, Femur Head Necrosis, Hip Fractures
- Being tested
- Liposomal bupivacaine plus bupivacaine, Ropivacaine
- Keywords
- Bupivacaine Liposome, PENG block, Hip Arthroplasty, Randomized Controlled Trial
- Medical subject headings
- Femoral Neck Fractures, Femur Head Necrosis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaine plus bupivacaineDrug
Also called LB+B
Liposomal bupivacaine is a prolonged-release formulation of the local anesthetic bupivacaine. This intervention involves the administration of liposomal bupivacaine plus bupivacaine as a local anesthetic for the pericapsular nerve group (PENG) block under ultrasound guidance. Liposomal bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This formulation is designed to provide extended pain relief as compared to conventional bupivacaine formulations.
RopivacaineDrug
Also called R
Ropivacaine is a commonly used local anesthetic in clinical practice, and it serves as the active comparator intervention in this study. Participants in the comparator arm will receive ropivacaine as a local anesthetic for the PENG block under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine plus Bupivacaine Intervention | Experimental | Participants in this arm will receive liposomal bupivacaine(LB) plus bupivacaine(B) as a local anesthetic for PENG block under ultrasound guidance. Liposomal bupivacaine plus bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of liposomal bupivacaine plus bupivacaine compared to the standard local anesthetic, ropivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery. Receives: Drug: Liposomal bupivacaine plus bupivacaine |
| Ropivacaine Intervention | Active comparator | Participants in this arm will receive ropivacaine (R) as a local anesthetic for the PENG block under ultrasound guidance. Ropivacaine, a routinely used local anesthetic in clinical practice, is being compared to liposomal bupivacaine plus bupivacaine to assess its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of ropivacaine in comparison to the investigational intervention, liposomal bupivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Opioid Consumption
This primary outcome entails tracking and assessing the total opioid consumption by participants following hip replacement surgery. The evaluation includes quantifying the amount of opioids prescribed and consumed by participants for pain management post-surgery. Opioid medications administered will be converted to morphine equivalents based on established conversion ratios. By analyzing overall opioid consumption, the study aims to evaluate the efficacy of the interventions in managing postoperative pain.
Measured: this outcome will be monitored and recorded within 72 hours postoperatively
Secondary outcomes (4)
Pain intensity
Pain intensity will be assessed using the Numerical Rating Scale (NRS), a 0-10 scale where 0 represents no pain and 10 represents the worst imaginable pain. Pain intensity will be measured at 10 time points: at baseline, 30min after PENG block, at Post Anesthesia Care Unit(PACU), 6 hours, 12 hours, and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery.
Measured: at multiple time points within 72 hours post-surgery.
Time to First Rescue Analgesic
Time to first rescue analgesic will be recorded as the interval from the end of the surgery to the administration of the first dose of rescue analgesic medication postoperatively.
Measured: 72 hours after surgery.
Incidence of Complications or Adverse Events
This outcome focuses on monitoring and documenting any adverse events or complications that may arise as a result of the interventions, including liposomal bupivacaine and ropivacaine, during postoperative care following hip replacement surgery. The assessment involves the systematic identification, recording, and analysis of any untoward effects, adverse reactions, or complications experienced by participants attributable to the administered interventions. The aim is to evaluate the safety profile of both interventions and compare the incidence of complications between the treatment groups to ensure patient safety and well-being throughout the study period.
Measured: 90 days after the surgical procedure
Duration of Hospital Stay
The duration of hospital stay is a significant secondary outcome that involves recording and comparing the length of time each participant remains hospitalized following hip replacement surgery. This outcome provides insight into the postoperative recovery process and the potential impact of the administered interventions, including liposomal bupivacaine and ropivacaine, on the participants' recovery trajectory. Assessing the duration of hospitalization allows for the evaluation of factors such as pain management, mobility, and postoperative care that may influence the participants' readiness for discharge.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start4 Dec 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a parallel interventional design, where participants undergoing hip arthroplasty surgery will be allocated into two separate groups. One group will receive liposomal bupivacaine plus bupivacaine as a regional anesthetic for Pericapsular Nerve Group (PENG) block, while the other group will receive ropivacaine for the same purpose. Both interventions will be administered under ultrasound guidance. The study aims to compare the analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction between the two groups, with assessments conducted at multiple time points within 72 hours post-surgery. The parallel design allows for the direct comparison of the two interventions and their respective outcomes in managing postoperative pain following hip arthroplasty.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, MD, Study director, Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565910
- Sponsor's protocol ID
- TJ-IRB202407066
- Acronym
- PENG
- Status last verified
- Mar 2026
- First submitted
- 9 Aug 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data sets to be shared will include all collected individual participant data that underlie the results reported in any publications resulting from the trial. This would typically include data related to pain relief, opioid analgesic consumption, incidence of complications, and any other relevant outcomes assessed at multiple time points within 72 hours after surgery.
Publications
Carmichael JC, Keller DS, Baldini G, Bordeianou L, Weiss E, Lee L, Boutros M, McClane J, Feldman LS, Steele SR. Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017 Aug;60(8):761-784. doi: 10.1097/DCR.0000000000000883. No abstract available.
PubMed 28682962Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, Blondeel P, Hamming J, Dayan J, Ljungqvist O; ERAS Society. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017 May;139(5):1056e-1071e. doi: 10.1097/PRS.0000000000003242.
PubMed 28445352Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
PubMed 30877144Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
PubMed 30304509Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657McCann ME. Liposomal Bupivacaine. Anesthesiology. 2021 Feb 1;134(2):139-142. doi: 10.1097/ALN.0000000000003658. No abstract available.
PubMed 33433621
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for PENG Block on Post Operative Pain Management in Patients Undergoing Hip Arthroplasty: a Prospective, Randomized, Single Blind, Active Controlled Study
- ClinicalTrials.gov ID
- NCT06565910
- Acronym / sponsor ID
- PENG / TJ-IRB202407066
- Conditions
- Femoral Neck Fractures, Femur Head Necrosis, Hip Fractures
- Keywords
- Bupivacaine Liposome, PENG block, Hip Arthroplasty, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 22 Aug 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 goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are:
- Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction?
- What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery?
Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery.
Participants will:
- Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance.
- Undergo hip replacement surgery under spinal anesthesia.
- Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study utilizes a parallel interventional design, where participants undergoing hip arthroplasty surgery will be allocated into two separate groups. One group will receive liposomal bupivacaine plus bupivacaine as a regional anesthetic for Pericapsular Nerve Group (PENG) block, while the other group will receive ropivacaine for the same purpose. Both interventions will be administered under ultrasound guidance. The study aims to compare the analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction between the two groups, with assessments conducted at multiple time points within 72 hours post-surgery. The parallel design allows for the direct comparison of the two interventions and their respective outcomes in managing postoperative pain following hip arthroplasty.
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine plus Bupivacaine Intervention | Experimental | Drug: Liposomal bupivacaine plus bupivacaineParticipants in this arm will receive liposomal bupivacaine(LB) plus bupivacaine(B) as a local anesthetic for PENG block under ultrasound guidance. Liposomal bupivacaine plus bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of liposomal bupivacaine plus bupivacaine compared to the standard local anesthetic, ropivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery. |
| Ropivacaine Intervention | Active comparator | Drug: RopivacaineParticipants in this arm will receive ropivacaine (R) as a local anesthetic for the PENG block under ultrasound guidance. Ropivacaine, a routinely used local anesthetic in clinical practice, is being compared to liposomal bupivacaine plus bupivacaine to assess its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of ropivacaine in comparison to the investigational intervention, liposomal bupivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists(ASA) I~II
- Normal coagulation
- Clinical diagnosis of hip fracture
Key exclusion criteria (2 listed)
- Presence of severe systemic diseases or ASA grade III or higher
- Allergy to amide local anesthetics
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 |
|---|---|---|
| Liposomal bupivacaine plus bupivacaineAlso: LB+BLiposomal bupivacaine is a prolonged-release formulation of the local anesthetic bupivacaine. This intervention involves the administration of liposomal bupivacaine plus bupivacaine as a local anesthetic for the pericapsular nerve group (PENG) block under ultrasound guidance. Liposomal bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This formulation is designed to provide extended pain relief as compared to conventional bupivacaine formulations. | Drug | Liposomal Bupivacaine plus Bupivacaine Intervention |
| RopivacaineAlso: RRopivacaine is a commonly used local anesthetic in clinical practice, and it serves as the active comparator intervention in this study. Participants in the comparator arm will receive ropivacaine as a local anesthetic for the PENG block under ultrasound guidance. | Drug | Ropivacaine Intervention |
Primary outcome
Overall Opioid Consumption
Time frame: this outcome will be monitored and recorded within 72 hours postoperatively
This primary outcome entails tracking and assessing the total opioid consumption by participants following hip replacement surgery. The evaluation includes quantifying the amount of opioids prescribed and consumed by participants for pain management post-surgery. Opioid medications administered will be converted to morphine equivalents based on established conversion ratios. By analyzing overall opioid consumption, the study aims to evaluate the efficacy of the interventions in managing postoperative pain.
4 secondary outcomes
Pain intensity
Time frame: at multiple time points within 72 hours post-surgery.
Time to First Rescue Analgesic
Time frame: 72 hours after surgery.
Incidence of Complications or Adverse Events
Time frame: 90 days after the surgical procedure
Duration of Hospital Stay
Time frame: through study completion, an average of 1 year
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 13 Mar 2026.
- Background: PubMed 28682962Carmichael JC, Keller DS, Baldini G, Bordeianou L, Weiss E, Lee L, Boutros M, McClane J, Feldman LS, Steele SR. Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017 Aug;60(8):761-784. doi: 10.1097/DCR.0000000000000883. No abstract available.
- Background: PubMed 28445352Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, Blondeel P, Hamming J, Dayan J, Ljungqvist O; ERAS Society. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017 May;139(5):1056e-1071e. doi: 10.1097/PRS.0000000000003242.
- Background: PubMed 30877144Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
- Background: PubMed 30304509Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 33433621McCann ME. Liposomal Bupivacaine. Anesthesiology. 2021 Feb 1;134(2):139-142. doi: 10.1097/ALN.0000000000003658. No abstract available.
- a description of liposomal bupivacaine: EXPARELLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. individual participant data sets to be shared will include all collected individual participant data that underlie the results reported in any publications resulting from the trial. This would typically include data related to pain relief, opioid analgesic consumption, incidence of complications, and any other relevant outcomes assessed at multiple time points within 72 hours after surgery.
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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.
Wei Mei, MD study director
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine plus bupivacaine and Ropivacaine in people with Femoral Neck Fractures and Femur Head Necrosis, run by Huazhong University of Science and Technology 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 3 inclusion and 2 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 13 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xijian KE, MD (13429826148, kexijian@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Opioid Consumption (time frame: this outcome will be monitored and recorded within 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06565910, which also lists 6 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 13 Mar 2026.