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

NCT05476575 | Completed

• 1 other identifier: FJUH110133
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Acute

Keywords

pain; hydrogen inhalation; discectomy

Outcome Measures

Primary Outcomes (5)

• Post-operative pain

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

  immediately post-operative compared to pre-operative pain score measured in VAS

• 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

• 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

• 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

• 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 Outcomes (4)

• Inflammation marker, Interleukin-6

  immediate post-operation compared to pre-operation

• Inflammation marker, Interleukin-10

  immediate post-operation compared to pre-operation

• Inflammation marker, Tumor necrotic factor-alpha

  immediate post-operation compared to pre-operation

• Inflammation marker, Interleukin-1 beta

  immediate post-operation compared to pre-operation

Study Arms (2)

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.

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

Traditional care group

NO INTERVENTION

Patients allocating to this group received traditional intraoperative care.

Interventions

hydrogen inhalation, 4% concentration, given via nasal cannula OTHER

4% hydrogen inhalation via nasal cannula perioperatively

Hydrogen inhalation group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, 24300, Taiwan

Location

Related Publications (21)

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MeSH Terms

Conditions

Acute Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective case control study

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: July 27, 2022
• Study Start: October 28, 2021
• Primary Completion: December 30, 2024
• Study Completion: February 28, 2025
• Last Updated: February 17, 2026

Record last verified: 2025-02

Locations

TW (1)