Pain, AcuteNCT05476575
The Effect of Perioperative Hydrogen Inhalation on Post-operative Pain and Inflammation Cytokines
A study testing hydrogen inhalation, 4% concentration, given via nasal cannula in people with Pain, Acute, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial summary
To understand the impact of perioperative hydrogen inhalation on post-operative pain control and serum inflammation markers Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- hydrogen inhalation, 4% concentration, given via nasal cannula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Oct 2021to 7 Aug 2022
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with herniated disc leading to severe neuropathic pain refractory to conservative treatment, receiving endoscopic discectomy.
Who cannot join
- American Society of Anesthesiologists class IV or above
- Sever impairment of heart, lung, kidney and liver and autoimmune disease
- Less than 20 years old or older than 75 years old
- Patient refusal
- Severe complication occurring perioperatively
- Current pregnancy
- Hemoglobin less than 10g/dL.
Trial locations and contacts
1 site in 1 country.
About this study
To understand the impact of perioperative hydrogen inhalation on post-operative pain control and serum inflammation markers
Read the detailed description
Hydrogen is odorless, colorless gas existing in natural environment. It was traditionally thought as biologically inert gas, which means it does not participate in biological process. However, recent studies have demonstrated that ingestion of hydrogen have exerted therapeutic effect on skin squamous cell carcinoma and parasitic hepatitis. Ingestion of hydrogen could also attenuate ischemic-reperfusion injury after stroke by removing reactive oxygen species (ROS). Multiple studies also demonstrated that ingestion of hydrogen exhibit anti-inflammatory effect, leading to less post-operative cognitive impairment, lung graft injury in brain-dead mice and acute lung injury.
Means of hydrogen ingestion include oral, inhalation or intravenous injection. Inhalation through simple mask, nasal cannula or ventilator is most convenient way. It has been proved that low concentration of hydrogen inhalation (1%-4%) is effective and safe without causing adverse effects on hemodynamic, respiration or even data of arterial blood gas analysis. High concentration of hydrogen inhalation is proven to be harmless and is often used in diving, treating decompression sickness and preventing arterio-venous thromboembolism.
Current data suggests that microglial cells in dorsal root ganglion are activated by danger-associated molecular pattern (DAMP) through toll-like receptor response (TLR) after external insults. Lipopolysaccharides (LPS) are recognized as TLR-4 receptor agonist and data revealed that LPS is associated with significant neuroinflammation and chronic pain process. Peripheral blood monocyte cells(PBSC) could have pro- (e.g. Tumor necrosis factor-α(TNF-α)、Interleukin-6(IL-6)、Interferon-γ(INF-γ) ) and anti- inflammation (e.g. IL-4、IL-5、IL-9、IL-10) cytokines release after LPS stimulation.
Current data suggests that hydrogen-rich water ingestion could reduce inflammation and pain score in animal model. Hydrogen inhalation is associated with decrease of pro-inflammation cytokines, such as IL-1β, IL-6, TNF-α and INF-γ. Besides, hydrogen inhalation could lead to reduction of pain in rats with high level spinal cord injury.
In addition to observing the difference of pain score between groups, we could also observe the differences between pro- and anti- inflammation cytokines in PBSC after LPS stimulation in patients receiving or not receiving hydrogen inhalation. This could tell us whether the inflammation process is inhibited in cellular level by hydrogen inhalation. To our knowledge, there is no human clinical trials discussing the effect of hydrogen inhalation on chronic pain. We hope to understand the actual impact of hydrogen inhalation on post-operative pain score and inflammation. Further larger scale randomized clinical trials could be carried on based on this result.
- Conditions
- Pain, Acute
- Being tested
- hydrogen inhalation, 4% concentration, given via nasal cannula
- Keywords
- pain, hydrogen inhalation, discectomy
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrogen inhalation, 4% concentration, given via nasal cannulaOther
4% hydrogen inhalation via nasal cannula perioperatively
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen inhalation group | Experimental | Patients allocating to this group received hydrogen inhalation (4% hydrogen given via nasal cannula) with other normal intraoperative care throughout the whole procedure. Receives: Other: hydrogen inhalation, 4% concentration, given via nasal cannula |
| Traditional care group | No intervention | Patients allocating to this group received traditional intraoperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-operative pain, measured in Numeric Rating Scale (NRS)
Measured: 12 hours after operation compared to pre-operative pain score measured in NRS
Post-operative pain
Post-operative pain, measured in Numeric Rating Scale (NRS)
Measured: 24 hours after operation compared to pre-operative pain score measured in NRS
Post-operative pain
Post-operative pain, measured in Numeric Rating Scale (NRS)
Measured: 1 month after operation compared to pre-operative pain score measured in NRS
Postoperative Pain
1 hour after operation compared to pre-operative pain score measured in NRS
Measured: 1 hour after operation compared to pre-operative pain score measured in NRS
Postoperative Pain
Postoperative pain, measured in Numeric Rating Scale (NRS)
Measured: At Postoperative Care Unit (PACU) immediately after surgery was completed, compared to preoperative pain, measured in NRS
Postoperative Pain
Post-operative pain, measured in Numeric Rating Scale (NRS)
Measured: 6 hours after operation compared to pre-operative pain score measured in NRS
Secondary outcomes (4)
Inflammation marker, Interferon-gamma
Interferon-gamma
Measured: immediate post-operation compared to pre-operation
Inflammation marker, Interleukin-10
Interleukin-10
Measured: immediate post-operation compared to pre-operation
Inflammation marker, Tumor necrotic factor-alpha
Tumor necrotic factor-alpha
Measured: immediate post-operation compared to pre-operation
Inflammation marker, Interleukin-1 beta
Interleukin-1 beta
Measured: immediate post-operation compared to pre-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start28 Oct 2021
- Primary completion7 Jul 2022
- Study completion7 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective case control study
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476575
- Sponsor's protocol ID
- FJUH110133
- Status last verified
- Feb 2025
- First submitted
- 27 Oct 2021
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ge L, Yang M, Yang NN, Yin XX, Song WG. Molecular hydrogen: a preventive and therapeutic medical gas for various diseases. Oncotarget. 2017 Sep 21;8(60):102653-102673. doi: 10.18632/oncotarget.21130. eCollection 2017 Nov 24.
PubMed 29254278Dole M, Wilson FR, Fife WP. Hyperbaric hydrogen therapy: a possible treatment for cancer. Science. 1975 Oct 10;190(4210):152-4. doi: 10.1126/science.1166304.
PubMed 1166304Gharib B, Hanna S, Abdallahi OM, Lepidi H, Gardette B, De Reggi M. Anti-inflammatory properties of molecular hydrogen: investigation on parasite-induced liver inflammation. C R Acad Sci III. 2001 Aug;324(8):719-24. doi: 10.1016/s0764-4469(01)01350-6.
PubMed 11510417Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. doi: 10.1038/nm1577. Epub 2007 May 7.
PubMed 17486089Zhang DQ, Feng H, Chen WC. Effects of hydrogen-rich saline on taurocholate-induced acute pancreatitis in rat. Evid Based Complement Alternat Med. 2013;2013:731932. doi: 10.1155/2013/731932. Epub 2013 Jul 28.
PubMed 23983797Hou Z, Luo W, Sun X, Hao S, Zhang Y, Xu F, Wang Z, Liu B. Hydrogen-rich saline protects against oxidative damage and cognitive deficits after mild traumatic brain injury. Brain Res Bull. 2012 Sep 1;88(6):560-5. doi: 10.1016/j.brainresbull.2012.06.006. Epub 2012 Jun 26.
PubMed 22742936Xie K, Yu Y, Huang Y, Zheng L, Li J, Chen H, Han H, Hou L, Gong G, Wang G. Molecular hydrogen ameliorates lipopolysaccharide-induced acute lung injury in mice through reducing inflammation and apoptosis. Shock. 2012 May;37(5):548-55. doi: 10.1097/SHK.0b013e31824ddc81.
PubMed 22508291Xin Y, Liu H, Zhang P, Chang L, Xie K. Molecular hydrogen inhalation attenuates postoperative cognitive impairment in rats. Neuroreport. 2017 Aug 2;28(11):694-700. doi: 10.1097/WNR.0000000000000824.
PubMed 28614179Zhou H, Fu Z, Wei Y, Liu J, Cui X, Yang W, Ding W, Pan P, Li W. Hydrogen inhalation decreases lung graft injury in brain-dead donor rats. J Heart Lung Transplant. 2013 Feb;32(2):251-8. doi: 10.1016/j.healun.2012.11.007. Epub 2012 Dec 28.
PubMed 23273744Ono H, Nishijima Y, Ohta S, Sakamoto M, Kinone K, Horikosi T, Tamaki M, Takeshita H, Futatuki T, Ohishi W, Ishiguro T, Okamoto S, Ishii S, Takanami H. Hydrogen Gas Inhalation Treatment in Acute Cerebral Infarction: A Randomized Controlled Clinical Study on Safety and Neuroprotection. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2587-2594. doi: 10.1016/j.jstrokecerebrovasdis.2017.06.012. Epub 2017 Jun 29.
PubMed 28669654Fontanari P, Badier M, Guillot C, Tomei C, Burnet H, Gardette B, Jammes Y. Changes in maximal performance of inspiratory and skeletal muscles during and after the 7.1-MPa Hydra 10 record human dive. Eur J Appl Physiol. 2000 Mar;81(4):325-8. doi: 10.1007/s004210050050.
PubMed 10664092Lillo RS, Parker EC, Porter WR. Decompression comparison of helium and hydrogen in rats. J Appl Physiol (1985). 1997 Mar;82(3):892-901. doi: 10.1152/jappl.1997.82.3.892.
PubMed 9074979Abraini JH, Gardette-Chauffour MC, Martinez E, Rostain JC, Lemaire C. Psychophysiological reactions in humans during an open sea dive to 500 m with a hydrogen-helium-oxygen mixture. J Appl Physiol (1985). 1994 Mar;76(3):1113-8. doi: 10.1152/jappl.1994.76.3.1113.
PubMed 8005852Kwok YH, Hutchinson MR, Gentgall MG, Rolan PE. Increased responsiveness of peripheral blood mononuclear cells to in vitro TLR 2, 4 and 7 ligand stimulation in chronic pain patients. PLoS One. 2012;7(8):e44232. doi: 10.1371/journal.pone.0044232. Epub 2012 Aug 28.
PubMed 22937165Zhao J, Bi W, Xiao S, Lan X, Cheng X, Zhang J, Lu D, Wei W, Wang Y, Li H, Fu Y, Zhu L. Neuroinflammation induced by lipopolysaccharide causes cognitive impairment in mice. Sci Rep. 2019 Apr 8;9(1):5790. doi: 10.1038/s41598-019-42286-8.
PubMed 30962497
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Hydrogen Inhalation on Post-operative Pain and Inflammation Cytokines
- ClinicalTrials.gov ID
- NCT05476575
- Acronym / sponsor ID
- FJUH110133
- Conditions
- Pain, Acute
- Keywords
- pain, hydrogen inhalation, discectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Aug 2022 (actual)
- First posted
- 27 Jul 2022 (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.
To understand the impact of perioperative hydrogen inhalation on post-operative pain control and serum inflammation markers
Detailed description
Hydrogen is odorless, colorless gas existing in natural environment. It was traditionally thought as biologically inert gas, which means it does not participate in biological process. However, recent studies have demonstrated that ingestion of hydrogen have exerted therapeutic effect on skin squamous cell carcinoma and parasitic hepatitis. Ingestion of hydrogen could also attenuate ischemic-reperfusion injury after stroke by removing reactive oxygen species (ROS). Multiple studies also demonstrated that ingestion of hydrogen exhibit anti-inflammatory effect, leading to less post-operative cognitive impairment, lung graft injury in brain-dead mice and acute lung injury.
Means of hydrogen ingestion include oral, inhalation or intravenous injection. Inhalation through simple mask, nasal cannula or ventilator is most convenient way. It has been proved that low concentration of hydrogen inhalation (1%-4%) is effective and safe without causing adverse effects on hemodynamic, respiration or even data of arterial blood gas analysis. High concentration of hydrogen inhalation is proven to be harmless and is often used in diving, treating decompression sickness and preventing arterio-venous thromboembolism.
Current data suggests that microglial cells in dorsal root ganglion are activated by danger-associated molecular pattern (DAMP) through toll-like receptor response (TLR) after external insults. Lipopolysaccharides (LPS) are recognized as TLR-4 receptor agonist and data revealed that LPS is associated with significant neuroinflammation and chronic pain process. Peripheral blood monocyte cells(PBSC) could have pro- (e.g. Tumor necrosis factor-α(TNF-α)、Interleukin-6(IL-6)、Interferon-γ(INF-γ) ) and anti- inflammation (e.g. IL-4、IL-5、IL-9、IL-10) cytokines release after LPS stimulation.
Current data suggests that hydrogen-rich water ingestion could reduce inflammation and pain score in animal model. Hydrogen inhalation is associated with decrease of pro-inflammation cytokines, such as IL-1β, IL-6, TNF-α and INF-γ. Besides, hydrogen inhalation could lead to reduction of pain in rats with high level spinal cord injury.
In addition to observing the difference of pain score between groups, we could also observe the differences between pro- and anti- inflammation cytokines in PBSC after LPS stimulation in patients receiving or not receiving hydrogen inhalation. This could tell us whether the inflammation process is inhibited in cellular level by hydrogen inhalation. To our knowledge, there is no human clinical trials discussing the effect of hydrogen inhalation on chronic pain. We hope to understand the actual impact of hydrogen inhalation on post-operative pain score and inflammation. Further larger scale randomized clinical trials could be carried on based on this result.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective case control study
| Arm | Type | Receives |
|---|---|---|
| Hydrogen inhalation group | Experimental | Other: hydrogen inhalation, 4% concentration, given via nasal cannulaPatients allocating to this group received hydrogen inhalation (4% hydrogen given via nasal cannula) with other normal intraoperative care throughout the whole procedure. |
| Traditional care group | No intervention | –Patients allocating to this group received traditional intraoperative care. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with herniated disc leading to severe neuropathic pain refractory to conservative treatment, receiving endoscopic discectomy.
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists class IV or above
- Sever impairment of heart, lung, kidney and liver and autoimmune disease
- Less than 20 years old or older than 75 years old
- Patient refusal
- Severe complication occurring perioperatively
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 |
|---|---|---|
| hydrogen inhalation, 4% concentration, given via nasal cannula4% hydrogen inhalation via nasal cannula perioperatively | Other | Hydrogen inhalation group |
Primary outcome
Post-operative pain
Time frame: 12 hours after operation compared to pre-operative pain score measured in NRS
Post-operative pain, measured in Numeric Rating Scale (NRS)
Post-operative pain
Time frame: 24 hours after operation compared to pre-operative pain score measured in NRS
Post-operative pain, measured in Numeric Rating Scale (NRS)
Post-operative pain
Time frame: 1 month after operation compared to pre-operative pain score measured in NRS
Post-operative pain, measured in Numeric Rating Scale (NRS)
Postoperative Pain
Time frame: 1 hour after operation compared to pre-operative pain score measured in NRS
1 hour after operation compared to pre-operative pain score measured in NRS
Postoperative Pain
Time frame: At Postoperative Care Unit (PACU) immediately after surgery was completed, compared to preoperative pain, measured in NRS
Postoperative pain, measured in Numeric Rating Scale (NRS)
Postoperative Pain
Time frame: 6 hours after operation compared to pre-operative pain score measured in NRS
Post-operative pain, measured in Numeric Rating Scale (NRS)
4 secondary outcomes
Inflammation marker, Interferon-gamma
Time frame: immediate post-operation compared to pre-operation
Inflammation marker, Interleukin-10
Time frame: immediate post-operation compared to pre-operation
Inflammation marker, Tumor necrotic factor-alpha
Time frame: immediate post-operation compared to pre-operation
Inflammation marker, Interleukin-1 beta
Time frame: immediate post-operation compared to pre-operation
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 Aug 2026.
- Background: PubMed 29254278Ge L, Yang M, Yang NN, Yin XX, Song WG. Molecular hydrogen: a preventive and therapeutic medical gas for various diseases. Oncotarget. 2017 Sep 21;8(60):102653-102673. doi: 10.18632/oncotarget.21130. eCollection 2017 Nov 24.
- Background: PubMed 1166304Dole M, Wilson FR, Fife WP. Hyperbaric hydrogen therapy: a possible treatment for cancer. Science. 1975 Oct 10;190(4210):152-4. doi: 10.1126/science.1166304.
- Background: PubMed 11510417Gharib B, Hanna S, Abdallahi OM, Lepidi H, Gardette B, De Reggi M. Anti-inflammatory properties of molecular hydrogen: investigation on parasite-induced liver inflammation. C R Acad Sci III. 2001 Aug;324(8):719-24. doi: 10.1016/s0764-4469(01)01350-6.
- Background: PubMed 17486089Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. doi: 10.1038/nm1577. Epub 2007 May 7.
- Background: PubMed 23983797Zhang DQ, Feng H, Chen WC. Effects of hydrogen-rich saline on taurocholate-induced acute pancreatitis in rat. Evid Based Complement Alternat Med. 2013;2013:731932. doi: 10.1155/2013/731932. Epub 2013 Jul 28.
- Background: PubMed 22742936Hou Z, Luo W, Sun X, Hao S, Zhang Y, Xu F, Wang Z, Liu B. Hydrogen-rich saline protects against oxidative damage and cognitive deficits after mild traumatic brain injury. Brain Res Bull. 2012 Sep 1;88(6):560-5. doi: 10.1016/j.brainresbull.2012.06.006. Epub 2012 Jun 26.
- Background: PubMed 22508291Xie K, Yu Y, Huang Y, Zheng L, Li J, Chen H, Han H, Hou L, Gong G, Wang G. Molecular hydrogen ameliorates lipopolysaccharide-induced acute lung injury in mice through reducing inflammation and apoptosis. Shock. 2012 May;37(5):548-55. doi: 10.1097/SHK.0b013e31824ddc81.
- Background: PubMed 28614179Xin Y, Liu H, Zhang P, Chang L, Xie K. Molecular hydrogen inhalation attenuates postoperative cognitive impairment in rats. Neuroreport. 2017 Aug 2;28(11):694-700. doi: 10.1097/WNR.0000000000000824.
- Background: PubMed 23273744Zhou H, Fu Z, Wei Y, Liu J, Cui X, Yang W, Ding W, Pan P, Li W. Hydrogen inhalation decreases lung graft injury in brain-dead donor rats. J Heart Lung Transplant. 2013 Feb;32(2):251-8. doi: 10.1016/j.healun.2012.11.007. Epub 2012 Dec 28.
- Background: PubMed 28669654Ono H, Nishijima Y, Ohta S, Sakamoto M, Kinone K, Horikosi T, Tamaki M, Takeshita H, Futatuki T, Ohishi W, Ishiguro T, Okamoto S, Ishii S, Takanami H. Hydrogen Gas Inhalation Treatment in Acute Cerebral Infarction: A Randomized Controlled Clinical Study on Safety and Neuroprotection. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2587-2594. doi: 10.1016/j.jstrokecerebrovasdis.2017.06.012. Epub 2017 Jun 29.
- Background: PubMed 10664092Fontanari P, Badier M, Guillot C, Tomei C, Burnet H, Gardette B, Jammes Y. Changes in maximal performance of inspiratory and skeletal muscles during and after the 7.1-MPa Hydra 10 record human dive. Eur J Appl Physiol. 2000 Mar;81(4):325-8. doi: 10.1007/s004210050050.
- Background: PubMed 9074979Lillo RS, Parker EC, Porter WR. Decompression comparison of helium and hydrogen in rats. J Appl Physiol (1985). 1997 Mar;82(3):892-901. doi: 10.1152/jappl.1997.82.3.892.
- Individual participant dataSharing planned: Undecided
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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 hydrogen inhalation, 4% concentration, given via nasal cannula in people with Pain, Acute, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
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 1 inclusion and 7 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 Aug 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 Taiwan. 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?
Post-operative pain (time frame: 12 hours after operation compared to pre-operative pain score measured in NRS). The study lists 6 primary outcomes in all. 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 NCT05476575, which also lists 22 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 Aug 2026.