LidocaineNCT05901389
Continuous Lidocaine Infusion Via Closed Chest Drainage Tube for Pain Control After Thoracoscopic Partial Lung Resection
A study testing Lidocaine and Sufentanil in people with Lidocaine and Analgesia, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lidocaine, Analgesia, Pain, Postoperative
- What is being tested?
- Lidocaine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2023to 30 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants ages 18-70 years.
- participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery.
- American Society of Anesthesiologists classification (ASA)I-III.
Who cannot join
- severe heart failure, cardiac arrhythmias,the New York Heart Association(NYHA) classification≥III.
- hypersensitivity to lidocaine,History of local anesthetic poisoning.
- severe renal or hepatic dysfunction.
- body mass index (BMI)>35 kg m-2.
- severe pleural adhesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Continuous Lidocaine Infusion Via Closed Chest Drainage Tube on Postoperative Analgesia for Patients Undergoing Thoracoscopic Partial Lung Resection: a Single-center Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. The main questions it aims to answer are:
- To explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy.
- Whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery.
For participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). The comparison group only accept the intravenous analgesia after surgery.
Read the detailed description
At present, multimodal analgesia has been the most commonly used approaches for the treatment of postoperative pain of thoracic surgery, including steroidal anti-inflammatory drugs, administration of opioid, and local anesthesia.
The investigators found that continuous lidocaine analgesia with local anesthesia through thoracic closed drainage tube could improve postoperative pain caused by drainage tube retention, reduce postoperative pain score, and improve postoperative recovery of respiratory function in patients. In the protocol, lidocaine was continuously pumped with a superficial anesthetic effect on the pleura, while mucosal absorption was almost equivalent to intravenous infusion, so its systemic anti-inflammatory effect is also explored.
In the protocol，participants will be randomized in a 1:1 ratio to the control or experimental groups. The experimental group received a continuous infusion of lidocaineThe experimental group used 2% lidocaine 100ml, and the control group was the conventional treatment group. The control group received only standard intravenous analgesia。In addition to receiving simple intravenous analgesia, the experimental group also received continuous infusion of lidocaine in the pleural cavity.
- Conditions
- Lidocaine, Analgesia, Pain, Postoperative, Thoracic Surgery
- Being tested
- Lidocaine, Sufentanil
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Continuous intrapleural infusion via epidural tube fixed in the closed chest drainage tube, connected to an electronic analgesic pump (pulse 1 mL/30 min + continuous 2 mL/h).
SufentanilDrug
Patient-controlled intravenous analgesia (PCIA): reduced dose 1.0-1.5 µg/kg in the lidocaine arm, standard dose 2.0-2.5 µg/kg in the control arm, both for 48 h.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA | Experimental | Patients receive continuous intrapleural lidocaine infusion via the closed chest drainage tube (pulse 1 mL/30 min + continuous 2 mL/h) combined with reduced-dose sufentanil patient-controlled intravenous analgesia (PCIA, 1.0-1.5 µg/kg for 48 h). Receives: Drug: Lidocaine; Drug: Sufentanil |
| Standard-dose sufentanil PCIA | Active comparator | Patients receive standard-dose sufentanil PCIA (2.0-2.5 µg/kg for 48 h) alone. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score（NRS）
The primary outcome is the incidence of a numeric rating scale (NRS) pain score > 3 on coughing/movement at 24 hours postoperatively (movement-evoked pain only).
Measured: Day 1
Secondary outcomes (15)
Changes in postoperative pain
Changes in postoperative pain score (NRS) at 12h and 48h until extubation. The full name of NRS score is Numerical Rating Scale. The minimum value of NRS score is 0 and the maximum value is 10. Patients can score themselves according to the pain level corresponding to the number, A score of 0 represents painless, 1-3 represents mild pain, 4-6 represents moderate pain and should be intervened, 7-10 represents severe pain and requires urgent treatment.
Measured: Day 2
the use of flurbiprofen axetil
the amount of rescue analgesic drugs flurbiprofen axetil used
Measured: Day 3
the use of dolantin
the amount of rescue analgesic drugs dolantin used
Measured: Day 3
the use of opioids
total amount of opioid use within 48h after surgery
Measured: Day 2
postoperative adverse events
the incidence of nausea, vomiting, and vertigo after surgery
Measured: Day 3
the amount of postoperative wound drainage
total amount of fluid drained after surgery
Measured: Day 3
C-reactive protein
The inflammatory marker of participants will be test after surgery
Measured: Day 1
interleukin-6
The inflammatory marker of participants will be test after surgery
Measured: Day 1
postoperative delusion
The incidence of postoperative delusion.
Measured: Day 3
drainage extraction
The time taken for the patient to remove the drain after surgery
Measured: up to 24 hours (before extubation)
ICU stay time
The length of time the patient remains in the ICU.
Measured: From date of ICU admission until the date of leaving ICU, assessed up to 5 days.
postoperative pulmonary complications
The probability of patients acquiring pulmonary complications after surgery.
Measured: Day 3
hospital length of stay
The time between hospital admission and discharge
Measured: From date of hospital admission until the date of discharge,assessed up to 15 days.
healing rate of drainage wound
The healing rate of drainage wound at 21 days after surgery.
Measured: Day 21
readmission rate
The readmission rate of patients in one month after surgery.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start7 Jun 2023
- Primary completion22 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for LidocaineStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- lidocaine will be injection by electronic analgesic pump, and the pulse infusion speed is 1ml / 30min, and 2ml / h for continuous infusion
- Masking
- None (open label)
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinying Zhang, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901389
- Sponsor's protocol ID
- KYLL-202210-071-1
- Status last verified
- Jul 2023
- First submitted
- 3 May 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdallah FW, Brull R. Is sciatic nerve block advantageous when combined with femoral nerve block for postoperative analgesia following total knee arthroplasty? A systematic review. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):493-8. doi: 10.1097/AAP.0b013e318228d5d4.
PubMed 21857266Barletta M, Reed R. Local Anesthetics: Pharmacology and Special Preparations. Vet Clin North Am Small Anim Pract. 2019 Nov;49(6):1109-1125. doi: 10.1016/j.cvsm.2019.07.004. Epub 2019 Aug 30.
PubMed 31474415Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012 Summer;59(2):90-101; quiz 102-3. doi: 10.2344/0003-3006-59.2.90.
PubMed 22822998Camorcia M, Capogna G, Columb MO. Effect of sex and pregnancy on the potency of intrathecal bupivacaine: determination of ED(5)(0) for motor block with the up-down sequential allocation method. Eur J Anaesthesiol. 2011 Apr;28(4):240-4.
PubMed 21513074Capdevila X, Pirat P, Bringuier S, Gaertner E, Singelyn F, Bernard N, Choquet O, Bouaziz H, Bonnet F; French Study Group on Continuous Peripheral Nerve Blocks. Continuous peripheral nerve blocks in hospital wards after orthopedic surgery: a multicenter prospective analysis of the quality of postoperative analgesia and complications in 1,416 patients. Anesthesiology. 2005 Nov;103(5):1035-45. doi: 10.1097/00000542-200511000-00018.
PubMed 16249678Choquet O, Noble GB, Abbal B, Morau D, Bringuier S, Capdevila X. Subparaneural versus circumferential extraneural injection at the bifurcation level in ultrasound-guided popliteal sciatic nerve blocks: a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):306-11. doi: 10.1097/AAP.0000000000000095.
PubMed 24918330Dalkilic N, Tuncer S, Burat I. Dexmedetomidine augments the effect of lidocaine: power spectrum and nerve conduction velocity distribution study. BMC Anesthesiol. 2015 Mar 6;15:24. doi: 10.1186/s12871-015-0009-9. eCollection 2015.
PubMed 25762864De Buck F, Devroe S, Missant C, Van de Velde M. Regional anesthesia outside the operating room: indications and techniques. Curr Opin Anaesthesiol. 2012 Aug;25(4):501-7. doi: 10.1097/ACO.0b013e3283556f58.
PubMed 22673788Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.
PubMed 23587875Drachman D, Strichartz G. Potassium channel blockers potentiate impulse inhibition by local anesthetics. Anesthesiology. 1991 Dec;75(6):1051-61. doi: 10.1097/00000542-199112000-00018.
PubMed 1741497Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60.
PubMed 9192462Elmas C, Atanassoff PG. Combined inguinal paravascular (3-in-1) and sciatic nerve blocks for lower limb surgery. Reg Anesth. 1993 Mar-Apr;18(2):88-92.
PubMed 8489988Grape S, Kirkham KR, Baeriswyl M, Albrecht E. The analgesic efficacy of sciatic nerve block in addition to femoral nerve block in patients undergoing total knee arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2016 Oct;71(10):1198-209. doi: 10.1111/anae.13568. Epub 2016 Jul 29.
PubMed 27469381Green SB. How Many Subjects Does It Take To Do A Regression Analysis. Multivariate Behav Res. 1991 Jul 1;26(3):499-510. doi: 10.1207/s15327906mbr2603_7.
PubMed 26776715Gupta PK, Pace NL, Hopkins PM. Effect of body mass index on the ED50 volume of bupivacaine 0.5% for supraclavicular brachial plexus block. Br J Anaesth. 2010 Apr;104(4):490-5. doi: 10.1093/bja/aeq017. Epub 2010 Feb 18.
PubMed 20167584
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Lidocaine Infusion Via Closed Chest Drainage Tube on Postoperative Analgesia for Patients Undergoing Thoracoscopic Partial Lung Resection: a Single-center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05901389
- Acronym / sponsor ID
- KYLL-202210-071-1
- Conditions
- Lidocaine, Analgesia, Pain, Postoperative, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Jun 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.
The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. The main questions it aims to answer are:
- To explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy.
- Whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery.
For participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). The comparison group only accept the intravenous analgesia after surgery.
Detailed description
At present, multimodal analgesia has been the most commonly used approaches for the treatment of postoperative pain of thoracic surgery, including steroidal anti-inflammatory drugs, administration of opioid, and local anesthesia.
The investigators found that continuous lidocaine analgesia with local anesthesia through thoracic closed drainage tube could improve postoperative pain caused by drainage tube retention, reduce postoperative pain score, and improve postoperative recovery of respiratory function in patients. In the protocol, lidocaine was continuously pumped with a superficial anesthetic effect on the pleura, while mucosal absorption was almost equivalent to intravenous infusion, so its systemic anti-inflammatory effect is also explored.
In the protocol，participants will be randomized in a 1:1 ratio to the control or experimental groups. The experimental group received a continuous infusion of lidocaineThe experimental group used 2% lidocaine 100ml, and the control group was the conventional treatment group. The control group received only standard intravenous analgesia。In addition to receiving simple intravenous analgesia, the experimental group also received continuous infusion of lidocaine in the pleural cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- lidocaine will be injection by electronic analgesic pump, and the pulse infusion speed is 1ml / 30min, and 2ml / h for continuous infusion
| Arm | Type | Receives |
|---|---|---|
| Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA | Experimental | Drug: Lidocaine, Drug: SufentanilPatients receive continuous intrapleural lidocaine infusion via the closed chest drainage tube (pulse 1 mL/30 min + continuous 2 mL/h) combined with reduced-dose sufentanil patient-controlled intravenous analgesia (PCIA, 1.0-1.5 µg/kg for 48 h). |
| Standard-dose sufentanil PCIA | Active comparator | Drug: SufentanilPatients receive standard-dose sufentanil PCIA (2.0-2.5 µg/kg for 48 h) alone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants ages 18-70 years.
- participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery.
- American Society of Anesthesiologists classification (ASA)I-III.
Key exclusion criteria (5 listed)
- severe heart failure, cardiac arrhythmias,the New York Heart Association(NYHA) classification≥III.
- hypersensitivity to lidocaine,History of local anesthetic poisoning.
- severe renal or hepatic dysfunction.
- body mass index (BMI)>35 kg m-2.
- severe pleural adhesions.
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 |
|---|---|---|
| LidocaineContinuous intrapleural infusion via epidural tube fixed in the closed chest drainage tube, connected to an electronic analgesic pump (pulse 1 mL/30 min + continuous 2 mL/h). | Drug | Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA |
| SufentanilPatient-controlled intravenous analgesia (PCIA): reduced dose 1.0-1.5 µg/kg in the lidocaine arm, standard dose 2.0-2.5 µg/kg in the control arm, both for 48 h. | Drug | Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA, Standard-dose sufentanil PCIA |
Primary outcome
postoperative pain score（NRS）
Time frame: Day 1
The primary outcome is the incidence of a numeric rating scale (NRS) pain score > 3 on coughing/movement at 24 hours postoperatively (movement-evoked pain only).
15 secondary outcomes
Changes in postoperative pain
Time frame: Day 2
the use of flurbiprofen axetil
Time frame: Day 3
the use of dolantin
Time frame: Day 3
the use of opioids
Time frame: Day 2
postoperative adverse events
Time frame: Day 3
the amount of postoperative wound drainage
Time frame: Day 3
C-reactive protein
Time frame: Day 1
interleukin-6
Time frame: Day 1
postoperative delusion
Time frame: Day 3
drainage extraction
Time frame: up to 24 hours (before extubation)
ICU stay time
Time frame: From date of ICU admission until the date of leaving ICU, assessed up to 5 days.
postoperative pulmonary complications
Time frame: Day 3
hospital length of stay
Time frame: From date of hospital admission until the date of discharge,assessed up to 15 days.
healing rate of drainage wound
Time frame: Day 21
readmission rate
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 21857266Abdallah FW, Brull R. Is sciatic nerve block advantageous when combined with femoral nerve block for postoperative analgesia following total knee arthroplasty? A systematic review. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):493-8. doi: 10.1097/AAP.0b013e318228d5d4.
- Background: PubMed 31474415Barletta M, Reed R. Local Anesthetics: Pharmacology and Special Preparations. Vet Clin North Am Small Anim Pract. 2019 Nov;49(6):1109-1125. doi: 10.1016/j.cvsm.2019.07.004. Epub 2019 Aug 30.
- Background: PubMed 22822998Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012 Summer;59(2):90-101; quiz 102-3. doi: 10.2344/0003-3006-59.2.90.
- Background: PubMed 21513074Camorcia M, Capogna G, Columb MO. Effect of sex and pregnancy on the potency of intrathecal bupivacaine: determination of ED(5)(0) for motor block with the up-down sequential allocation method. Eur J Anaesthesiol. 2011 Apr;28(4):240-4.
- Background: PubMed 16249678Capdevila X, Pirat P, Bringuier S, Gaertner E, Singelyn F, Bernard N, Choquet O, Bouaziz H, Bonnet F; French Study Group on Continuous Peripheral Nerve Blocks. Continuous peripheral nerve blocks in hospital wards after orthopedic surgery: a multicenter prospective analysis of the quality of postoperative analgesia and complications in 1,416 patients. Anesthesiology. 2005 Nov;103(5):1035-45. doi: 10.1097/00000542-200511000-00018.
- Background: PubMed 24918330Choquet O, Noble GB, Abbal B, Morau D, Bringuier S, Capdevila X. Subparaneural versus circumferential extraneural injection at the bifurcation level in ultrasound-guided popliteal sciatic nerve blocks: a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):306-11. doi: 10.1097/AAP.0000000000000095.
- Background: PubMed 25762864Dalkilic N, Tuncer S, Burat I. Dexmedetomidine augments the effect of lidocaine: power spectrum and nerve conduction velocity distribution study. BMC Anesthesiol. 2015 Mar 6;15:24. doi: 10.1186/s12871-015-0009-9. eCollection 2015.
- Background: PubMed 22673788De Buck F, Devroe S, Missant C, Van de Velde M. Regional anesthesia outside the operating room: indications and techniques. Curr Opin Anaesthesiol. 2012 Aug;25(4):501-7. doi: 10.1097/ACO.0b013e3283556f58.
- Background: PubMed 23587875Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.
- Background: PubMed 1741497Drachman D, Strichartz G. Potassium channel blockers potentiate impulse inhibition by local anesthetics. Anesthesiology. 1991 Dec;75(6):1051-61. doi: 10.1097/00000542-199112000-00018.
- Background: PubMed 9192462Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60.
- Background: PubMed 8489988Elmas C, Atanassoff PG. Combined inguinal paravascular (3-in-1) and sciatic nerve blocks for lower limb surgery. Reg Anesth. 1993 Mar-Apr;18(2):88-92.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Sufentanil in people with Lidocaine and Analgesia, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 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: finished, as of the sponsor's last update on 24 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score（NRS） (time frame: Day 1). 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 NCT05901389, which also lists 26 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 24 Sep 2026.