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

July 25, 2022 updated by: Fu Jen Catholic University Hospital
To understand the impact of perioperative hydrogen inhalation on post-operative pain control and serum inflammation markers

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24300
        • Recruiting
        • Fu Jen Catholic University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: immediately post-operative compared to pre-operative pain score measured in VAS
Post-operative pain, measured in visual analogue scale (VAS)
immediately post-operative compared to pre-operative pain score measured in VAS
Post-operative pain
Time Frame: 12 hours after operation compared to pre-operative pain score measured in VAS
Post-operative pain, measured in visual analogue scale (VAS)
12 hours after operation compared to pre-operative pain score measured in VAS
Post-operative pain
Time Frame: 24 hours after operation compared to pre-operative pain score measured in VAS
Post-operative pain, measured in visual analogue scale (VAS)
24 hours after operation compared to pre-operative pain score measured in VAS
Post-operative pain
Time Frame: 1 week after operation compared to pre-operative pain score measured in VAS
Post-operative pain, measured in visual analogue scale (VAS)
1 week after operation compared to pre-operative pain score measured in VAS
Post-operative pain
Time Frame: 1 month after operation compared to pre-operative pain score measured in VAS
Post-operative pain, measured in visual analogue scale (VAS)
1 month after operation compared to pre-operative pain score measured in VAS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation marker
Time Frame: immediate post-operation compared to pre-operation
Inflammation marker, IL-6, IL-10, TNF-alpha
immediate post-operation compared to pre-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2021

Primary Completion (Anticipated)

October 28, 2022

Study Completion (Anticipated)

October 28, 2022

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJUH110133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Acute

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe