Lung CancerNCT06135545
Bupivacaine Liposome Serrate Anterior Plane Block vs Traditional Thoracic Paravertebral Block
A study testing Bupivacaine Liposome SAPB and Traditional TPVB in people with Lung Cancer, run by Shiyou Wei at 1 site in China.
Trial summary
In this study, patients will receive bupivacaine liposome serratus anterior plane block or ropivacaine paraspinal block to manage postoperative pain. Follow-up visits will be conducted to investigate the patient's postoperative pain and recovery quality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bupivacaine Liposome SAPB and Traditional TPVB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 3 Oct 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective unilateral thoracoscopic lung surgery.
- Age between 18 and 75 years old.
- American Society of Anesthesiologists (ASA) classification I to III.
Who cannot join
- Contraindications to nerve block: puncture site infection, local anesthetic allergy, coagulation disorders or risk of bleeding.
- Hepatic or renal dysfunction.
- Pregnant, breastfeeding, possibility of pregnancy or planned pregnancy.
- Use of analgesic drugs before surgery or history of chronic pain or opioid abuse.
- Patients who refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Postoperative Analgesic Effects of Bupivacaine Liposome Serrate Anterior Plane Block (SAPB) Versus Traditional Thoracic Paravertebral Block (TPVB): A Randomized, Double-blinded Non-inferiority Clinical Trial
In this study, patients will receive bupivacaine liposome serratus anterior plane block or ropivacaine paraspinal block to manage postoperative pain. Follow-up visits will be conducted to investigate the patient's postoperative pain and recovery quality. The investigators hypothesize that the simple and safe serratus anterior plane block with a novel long-acting local anesthetic (bupivacaine liposome) has analgesic efficacy and recovery quality that is not inferior to the currently commonly used bupivacaine paraspinal block.
Read the detailed description
Extensive research suggests that paravertebral block can replace thoracic epidural anesthesia as the "gold standard" for thoracic surgery pain relief. However, this technique is more challenging than the fascial plane block and carries the risk of damaging the pleura or spinal nerve roots. The serratus anterior plane block (SAPB) was refined by Blanco et al. in 2013 and is a new, safe regional anesthesia technique that can block the lateral cutaneous branches of the intercostal nerves from T2 to T9, as well as the long thoracic nerve, providing intraoperative and postoperative pain relief for surgeries in this area. A meta-analysis has reported that it can be an alternative regional anesthesia method to paravertebral and intercostal nerve blocks, and is technically safer, more effective, easier to perform, and may have fewer adverse reactions, making it more favored by clinicians. However, a recent network meta-analysis of regional block techniques in thoracic surgery suggested that, in terms of postoperative pain scores at 24 hours, SAPB can relieve pain but is slightly inferior to paravertebral block.
The duration of action of currently used local anesthetics is short. Although various adjuvants have been proposed, such as dexamethasone and dexmedetomidine, there are currently no drugs approved by the FDA that reliably extend the duration of local anesthetics beyond 24 hours (PMID: 27749354). Liposomal encapsulation of bupivacaine can extend the release time of local anesthetics to 72-96 hours (PMID: 23229686, 28120158), with the potential to reduce pain scores at 72 hours postoperatively (PMID: 22067185). Liposomal bupivacaine (Hengrui, Jiangsu) is also the first long-acting local anesthetic currently on the market in China, sparking new hope for anesthesiologists to better manage postoperative pain.
This study hypothesizes, from a clinical perspective, that the use of long-acting local anesthetic liposomal bupivacaine in a simplified and safe serratus anterior plane block technique for regional pain relief postoperatively is not inferior to the widely accepted gold standard for thoracic pain relief-paravertebral block with ropivacaine.
- Conditions
- Lung Cancer
- Being tested
- Bupivacaine Liposome SAPB, Traditional TPVB
- Keywords
- Serratus anterior plane block, Thoracic paravertebral block, Liposomal bupivacaine, Video-assisted thoracoscopic surgery, Postoperative pain
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Liposome SAPBCombination product
Also called Bupivacaine Liposome Serrate Anterior Plane Block(SAPB)
Dilute 266mg of bupivacaine liposome with saline solution to 30ml.The patients are placed in the lateral position and the probe is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The investigators count the ribs inferiorly and laterally, until The investigators identify the fifth rib in the midaxillary line. The latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior) are then easily identifiable by ultrasound overlying the fifth rib.
Traditional TPVBCombination product
Also called Traditional Thoracic Paravertebral Block(TPVB)
The TPVB was recommended by the American Society of Anesthesiologists.The transducer is placed sagitally over a transverse process(TP), placing it at the center of the ultrasound image. Alternatively, the space in-between two adjacent transverse processes may be positioned at the center. The needle is inserted using an out-of-plane technique and advanced until the central TP is contacted, or else the cranial of the two, with no or minimal angulation in the sagittal plane or the transversal plane. Subsequently, the needle is walked off the TP into the TPV space and advanced 1 to 1.5 cm beyond the TP without further visualizing the needle tip on ultrasound. Entering of the needle tip into the TPV space can result in a loss of resistance to normal saline and by visualizing anterior displacement of the pleura upon injection. Select the fifth TP as the insertion point, and inject 20ml of 0.5% ropivacaine (Hengrui, Jiangsu) into the TPV space.
| Study group | Role | What they receive |
|---|---|---|
| T Group | Experimental | The T group used liposomal bupivacaine for ultrasound-guided serratus anterior plane block. Receives: Combination Product: Bupivacaine Liposome SAPB |
| C Group | Active comparator | The C group used traditional ropivacaine for ultrasound-guided paravertebral nerve block. Receives: Combination Product: Traditional TPVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative NRS pain score at 24 hours
Postoperative numeric rating scales pain score at 24 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.
Measured: 24 hours after the surgery
Secondary outcomes (4)
Postoperative QoR-15
The 15-item quality of recovery(QoR-15) after the surgery. The QoR-15 scale is a global measurement of postoperative recovery, consisting of 15 items with 10 points each, with a total score ranging from 0 (QoR very poor) to 150 (QoR very good).
Measured: 24 to 72 hours after the surgery
Cumulative opioid consumption after surgery
Cumulative opioid consumption after surgery
Measured: 72 hours after the surgery
AUC of postoperative pain score
Area under the curve(AUC) of pain score 72 hours after surgery
Measured: 72 hours after the surgery
Postoperative NRS pain score
Pain scores at other time points except for the primary outcome. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.
Measured: 1h, 6h, 48h, 72h after the surgery, separately.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Oct 2023 (estimated)
- Primary completion2 Oct 2023 (estimated)
- Study completion3 Oct 2023 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- Model description
- A randomized, double-blinded non-inferiority clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Jiong Song, MD., Study director, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135545
- Sponsor's protocol ID
- 2023LY0519
- Status last verified
- Oct 2023
- First submitted
- 11 Nov 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PubMed 26897642Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PubMed 23923989Chong M, Berbenetz N, Kumar K, Lin C. The serratus plane block for postoperative analgesia in breast and thoracic surgery: a systematic review and meta-analysis. Reg Anesth Pain Med. 2019 Oct 23:rapm-2019-100982. doi: 10.1136/rapm-2019-100982. Online ahead of print.
PubMed 31649029Sandeep B, Huang X, Li Y, Xiong D, Zhu B, Xiao Z. A comparison of regional anesthesia techniques in patients undergoing video-assisted thoracic surgery: A network meta-analysis. Int J Surg. 2022 Sep;105:106840. doi: 10.1016/j.ijsu.2022.106840. Epub 2022 Aug 24.
PubMed 36030040Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581.
PubMed 27749354Hu D, Onel E, Singla N, Kramer WG, Hadzic A. Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. Clin Drug Investig. 2013 Feb;33(2):109-15. doi: 10.1007/s40261-012-0043-z.
PubMed 23229686Rice D, Heil JW, Biernat L. Pharmacokinetic Profile and Tolerability of Liposomal Bupivacaine Following a Repeated Dose via Local Subcutaneous Infiltration in Healthy Volunteers. Clin Drug Investig. 2017 Mar;37(3):249-257. doi: 10.1007/s40261-017-0495-2.
PubMed 28120158Krediet AC, Moayeri N, van Geffen GJ, Bruhn J, Renes S, Bigeleisen PE, Groen GJ. Different Approaches to Ultrasound-guided Thoracic Paravertebral Block: An Illustrated Review. Anesthesiology. 2015 Aug;123(2):459-74. doi: 10.1097/ALN.0000000000000747.
PubMed 26083767Ding W, Chen Y, Li D, Wang L, Liu H, Wang H, Zeng X. Investigation of single-dose thoracic paravertebral analgesia for postoperative pain control after thoracoscopic lobectomy - A randomized controlled trial. Int J Surg. 2018 Sep;57:8-14. doi: 10.1016/j.ijsu.2018.07.006. Epub 2018 Jul 26.
PubMed 30056127
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Postoperative Analgesic Effects of Bupivacaine Liposome Serrate Anterior Plane Block (SAPB) Versus Traditional Thoracic Paravertebral Block (TPVB): A Randomized, Double-blinded Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06135545
- Acronym / sponsor ID
- 2023LY0519
- Conditions
- Lung Cancer
- Keywords
- Serratus anterior plane block, Thoracic paravertebral block, Liposomal bupivacaine, Video-assisted thoracoscopic surgery, Postoperative pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 2 Oct 2023 (estimated)
- Study completion
- 3 Oct 2023 (estimated)
- First posted
- 18 Nov 2023 (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.
In this study, patients will receive bupivacaine liposome serratus anterior plane block or ropivacaine paraspinal block to manage postoperative pain. Follow-up visits will be conducted to investigate the patient's postoperative pain and recovery quality. The investigators hypothesize that the simple and safe serratus anterior plane block with a novel long-acting local anesthetic (bupivacaine liposome) has analgesic efficacy and recovery quality that is not inferior to the currently commonly used bupivacaine paraspinal block.
Detailed description
Extensive research suggests that paravertebral block can replace thoracic epidural anesthesia as the "gold standard" for thoracic surgery pain relief. However, this technique is more challenging than the fascial plane block and carries the risk of damaging the pleura or spinal nerve roots. The serratus anterior plane block (SAPB) was refined by Blanco et al. in 2013 and is a new, safe regional anesthesia technique that can block the lateral cutaneous branches of the intercostal nerves from T2 to T9, as well as the long thoracic nerve, providing intraoperative and postoperative pain relief for surgeries in this area. A meta-analysis has reported that it can be an alternative regional anesthesia method to paravertebral and intercostal nerve blocks, and is technically safer, more effective, easier to perform, and may have fewer adverse reactions, making it more favored by clinicians. However, a recent network meta-analysis of regional block techniques in thoracic surgery suggested that, in terms of postoperative pain scores at 24 hours, SAPB can relieve pain but is slightly inferior to paravertebral block.
The duration of action of currently used local anesthetics is short. Although various adjuvants have been proposed, such as dexamethasone and dexmedetomidine, there are currently no drugs approved by the FDA that reliably extend the duration of local anesthetics beyond 24 hours (PMID: 27749354). Liposomal encapsulation of bupivacaine can extend the release time of local anesthetics to 72-96 hours (PMID: 23229686, 28120158), with the potential to reduce pain scores at 72 hours postoperatively (PMID: 22067185). Liposomal bupivacaine (Hengrui, Jiangsu) is also the first long-acting local anesthetic currently on the market in China, sparking new hope for anesthesiologists to better manage postoperative pain.
This study hypothesizes, from a clinical perspective, that the use of long-acting local anesthetic liposomal bupivacaine in a simplified and safe serratus anterior plane block technique for regional pain relief postoperatively is not inferior to the widely accepted gold standard for thoracic pain relief-paravertebral block with ropivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blinded non-inferiority clinical trial.
| Arm | Type | Receives |
|---|---|---|
| T Group | Experimental | Combination Product: Bupivacaine Liposome SAPBThe T group used liposomal bupivacaine for ultrasound-guided serratus anterior plane block. |
| C Group | Active comparator | Combination Product: Traditional TPVBThe C group used traditional ropivacaine for ultrasound-guided paravertebral nerve block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective unilateral thoracoscopic lung surgery.
- Age between 18 and 75 years old.
- American Society of Anesthesiologists (ASA) classification I to III.
Key exclusion criteria (5 listed)
- Contraindications to nerve block: puncture site infection, local anesthetic allergy, coagulation disorders or risk of bleeding.
- Hepatic or renal dysfunction.
- Pregnant, breastfeeding, possibility of pregnancy or planned pregnancy.
- Use of analgesic drugs before surgery or history of chronic pain or opioid abuse.
- Patients who refuse to participate.
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 Liposome SAPBAlso: Bupivacaine Liposome Serrate Anterior Plane Block(SAPB)Dilute 266mg of bupivacaine liposome with saline solution to 30ml.The patients are placed in the lateral position and the probe is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The investigators count the ribs inferiorly and laterally, until The investigators identify the fifth rib in the midaxillary line. The latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior) are then easily identifiable by ultrasound overlying the fifth rib. | Combination product | T Group |
| Traditional TPVBAlso: Traditional Thoracic Paravertebral Block(TPVB)The TPVB was recommended by the American Society of Anesthesiologists.The transducer is placed sagitally over a transverse process(TP), placing it at the center of the ultrasound image. Alternatively, the space in-between two adjacent transverse processes may be positioned at the center. The needle is inserted using an out-of-plane technique and advanced until the central TP is contacted, or else the cranial of the two, with no or minimal angulation in the sagittal plane or the transversal plane. Subsequently, the needle is walked off the TP into the TPV space and advanced 1 to 1.5 cm beyond the TP without further visualizing the needle tip on ultrasound. Entering of the needle tip into the TPV space can result in a loss of resistance to normal saline and by visualizing anterior displacement of the pleura upon injection. Select the fifth TP as the insertion point, and inject 20ml of 0.5% ropivacaine (Hengrui, Jiangsu) into the TPV space. | Combination product | C Group |
Primary outcome
Postoperative NRS pain score at 24 hours
Time frame: 24 hours after the surgery
Postoperative numeric rating scales pain score at 24 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.
4 secondary outcomes
Postoperative QoR-15
Time frame: 24 to 72 hours after the surgery
Cumulative opioid consumption after surgery
Time frame: 72 hours after the surgery
AUC of postoperative pain score
Time frame: 72 hours after the surgery
Postoperative NRS pain score
Time frame: 1h, 6h, 48h, 72h after the surgery, separately.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 26897642Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
- Background: PubMed 23923989Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
- Background: PubMed 31649029Chong M, Berbenetz N, Kumar K, Lin C. The serratus plane block for postoperative analgesia in breast and thoracic surgery: a systematic review and meta-analysis. Reg Anesth Pain Med. 2019 Oct 23:rapm-2019-100982. doi: 10.1136/rapm-2019-100982. Online ahead of print.
- Background: PubMed 36030040Sandeep B, Huang X, Li Y, Xiong D, Zhu B, Xiao Z. A comparison of regional anesthesia techniques in patients undergoing video-assisted thoracic surgery: A network meta-analysis. Int J Surg. 2022 Sep;105:106840. doi: 10.1016/j.ijsu.2022.106840. Epub 2022 Aug 24.
- Background: PubMed 27749354Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581.
- Background: PubMed 23229686Hu D, Onel E, Singla N, Kramer WG, Hadzic A. Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. Clin Drug Investig. 2013 Feb;33(2):109-15. doi: 10.1007/s40261-012-0043-z.
- Background: PubMed 28120158Rice D, Heil JW, Biernat L. Pharmacokinetic Profile and Tolerability of Liposomal Bupivacaine Following a Repeated Dose via Local Subcutaneous Infiltration in Healthy Volunteers. Clin Drug Investig. 2017 Mar;37(3):249-257. doi: 10.1007/s40261-017-0495-2.
- Background: PubMed 26083767Krediet AC, Moayeri N, van Geffen GJ, Bruhn J, Renes S, Bigeleisen PE, Groen GJ. Different Approaches to Ultrasound-guided Thoracic Paravertebral Block: An Illustrated Review. Anesthesiology. 2015 Aug;123(2):459-74. doi: 10.1097/ALN.0000000000000747.
- Results publication: PubMed 30056127Ding W, Chen Y, Li D, Wang L, Liu H, Wang H, Zeng X. Investigation of single-dose thoracic paravertebral analgesia for postoperative pain control after thoracoscopic lobectomy - A randomized controlled trial. Int J Surg. 2018 Sep;57:8-14. doi: 10.1016/j.ijsu.2018.07.006. Epub 2018 Jul 26.
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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.
Jiong Song, MD. study director
Shanghai Pulmonary Hospital, Shanghai, China
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 Liposome SAPB and Traditional TPVB in people with Lung Cancer, run by Shiyou Wei 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 5 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: withdrawn, as of the sponsor's last update on 9 Jan 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 was withdrawn before enrolling participants, so there are no results.
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?
Postoperative NRS pain score at 24 hours (time frame: 24 hours after the 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 NCT06135545, which also lists 9 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 9 Jan 2025.