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

Sponsor
Fu Jen Catholic University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05476575
Collaborator
(none)
32
1
2
12
2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: hydrogen inhalation, 4% concentration, given via nasal cannula
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective case control studyProspective case control study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Perioperative Hydrogen Inhalation on Post-operative Pain and Inflammation Cytokines
Actual Study Start Date :
Oct 28, 2021
Anticipated Primary Completion Date :
Oct 28, 2022
Anticipated Study Completion Date :
Oct 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hydrogen inhalation group

Patients allocating to this group received hydrogen inhalation (4% hydrogen given via nasal cannula) with other normal intraoperative care throughout the whole procedure.

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

No Intervention: Traditional care group

Patients allocating to this group received traditional intraoperative care.

Outcome Measures

Primary Outcome Measures

  1. Post-operative pain [immediately post-operative compared to pre-operative pain score measured in VAS]

    Post-operative pain, measured in visual analogue scale (VAS)

  2. Post-operative pain [12 hours after operation compared to pre-operative pain score measured in VAS]

    Post-operative pain, measured in visual analogue scale (VAS)

  3. Post-operative pain [24 hours after operation compared to pre-operative pain score measured in VAS]

    Post-operative pain, measured in visual analogue scale (VAS)

  4. Post-operative pain [1 week after operation compared to pre-operative pain score measured in VAS]

    Post-operative pain, measured in visual analogue scale (VAS)

  5. Post-operative pain [1 month after operation compared to pre-operative pain score measured in VAS]

    Post-operative pain, measured in visual analogue scale (VAS)

Secondary Outcome Measures

  1. Inflammation marker [immediate post-operation compared to pre-operation]

    Inflammation marker, IL-6, IL-10, TNF-alpha

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fu Jen Catholic University Hospital New Taipei City Taiwan 24300

Sponsors and Collaborators

  • Fu Jen Catholic University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fu Jen Catholic University Hospital
ClinicalTrials.gov Identifier:
NCT05476575
Other Study ID Numbers:
  • FJUH110133
First Posted:
Jul 27, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fu Jen Catholic University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022