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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476575
• Other study ID #: FJUH110133
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: October 2021
• Source: Fu Jen Catholic University Hospital
• Contact: Chao Hsien Sung, MD
• Phone: +886-912072103
• Email: joe411002[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To understand the impact of perioperative hydrogen inhalation on post-operative pain control and serum inflammation markers

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Inflammation
• Pain, Acute
• Pain, Postoperative
• Respiratory Aspiration

Intervention

Other:
• hydrogen inhalation, 4% concentration, given via nasal cannula
4% hydrogen inhalation via nasal cannula perioperatively

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Post-operative pain, measured in visual analogue scale (VAS)	immediately post-operative compared to pre-operative pain score measured in VAS
Primary	Post-operative pain	Post-operative pain, measured in visual analogue scale (VAS)	12 hours after operation compared to pre-operative pain score measured in VAS
Primary	Post-operative pain	Post-operative pain, measured in visual analogue scale (VAS)	24 hours after operation compared to pre-operative pain score measured in VAS
Primary	Post-operative pain	Post-operative pain, measured in visual analogue scale (VAS)	1 week after operation compared to pre-operative pain score measured in VAS
Primary	Post-operative pain	Post-operative pain, measured in visual analogue scale (VAS)	1 month after operation compared to pre-operative pain score measured in VAS
Secondary	Inflammation marker	Inflammation marker, IL-6, IL-10, TNF-alpha	immediate post-operation compared to pre-operation