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The Effect of Perioperative Hydrogen Inhalation on Post-operative Pain and Inflammation Cytokines

The Effect of Perioperative Hydrogen Inhalation on Post-operative Pain and Inflammation Cytokines

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05476575
Enrollment
37
Registered
2022-07-27
Start date
2021-10-28
Completion date
2022-08-07
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute

Keywords

pain, hydrogen inhalation, discectomy

Brief summary

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.

Interventions

OTHERhydrogen inhalation, 4% concentration, given via nasal cannula

4% hydrogen inhalation via nasal cannula perioperatively

Sponsors

Fu Jen Catholic University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective case control study

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patient with herniated disc leading to severe neuropathic pain refractory to conservative treatment, receiving endoscopic discectomy.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain12 hours after operation compared to pre-operative pain score measured in NRSPost-operative pain, measured in Numeric Rating Scale (NRS)
Postoperative Pain1 hour after operation compared to pre-operative pain score measured in NRS1 hour after operation compared to pre-operative pain score measured in NRS

Secondary

MeasureTime frameDescription
Inflammation marker, Interferon-gammaimmediate post-operation compared to pre-operationInterferon-gamma
Inflammation marker, Interleukin-10immediate post-operation compared to pre-operationInterleukin-10
Inflammation marker, Tumor necrotic factor-alphaimmediate post-operation compared to pre-operationTumor necrotic factor-alpha
Inflammation marker, Interleukin-1 betaimmediate post-operation compared to pre-operationInterleukin-1 beta

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026