Clinical Trial: Efficacy of Intraoperative Nitrous Oxide for Chronic Postoperative Pain and the Role of Genetic Polymorphisms in Patients With Cervical Spinal Cord Injury: An Exploratory Single-Arm Prospective Interventional Study (Japan)

Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063106) titled 'Efficacy of Intraoperative Nitrous Oxide for Chronic Postoperative Pain and the Role of Genetic Polymorphisms in Patients With Cervical Spinal Cord Injury: An Exploratory Single-Arm Prospective Interventional Study' on Sept. 29.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Saitama Medical School

Condition: Condition - Traumatic cervical spinal cord injury Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To clarify the association between genetic polymorphisms and chronic-phase neuropathic pain in patients receiving intraoperative Nitrous oxides. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intraoperative nitrous oxide inhalation

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 20 or older with cervical spinal cord injury (classified as ASIA C or D) who were transported to Saitama Medical Center and determined to require surgery. Individuals who received a full explanation regarding participation in this study, demonstrated sufficient understanding, and provided written informed consent based on their own free will. Key exclusion criteria - 1) Pneumothorax or head trauma 2) Trauma to the limbs (fractures or nerve injuries) 3) Non-Japanese speakers 4) Impaired consciousness (making assessment difficult) 5) Patients already enrolled in another clinical trial 6) Comorbid psychiatric disorders (e.g., suicidal ideation) 7) Comorbid limb trauma 8) History of blood disorders 9) Patients taking NMDA receptor antagonists 10) Individuals who did not provide written informed consent 11) Individuals who withdrew consent 12) Any other individuals deemed unsuitable by the principal investigator Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 17 Day Anticipated trial start date - 2026 Year 12 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072200

Disclaimer: Curated by HT Syndication.