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Effectiveness of Intraoperative Nitrous Oxide for Postoperative Pain in Lumbar Spinal Fusion Surgery: A Randomized Controlled Trial.

Effectiveness of Intraoperative Nitrous Oxide for Postoperative Pain in Lumbar Spinal Fusion Surgery: A Randomized Controlled Trial. - Efficacy of N2O in PLIF for postoperative pain.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048817
Enrollment
80
Registered
2022-09-02
Start date
2022-09-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain

Interventions

Intervention is performed during general anesthesia
in the N2O group, general anesthesia is maintained with 60% N2O and 40% FIO2 after tracheal intubation. N2O administration will be terminated immediately after the end of surgery. Intervention is perf

Sponsors

Keiyu Orthopedic Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 20 years or older with ASA (American Society of Anesthesiologist) classification I-II who will undergo lumbar spinal fusion between September 2022 and April 2024 at Keiyu Orthopaedic Hospital will be included.

Exclusion criteria

Exclusion criteria: Due to trauma (fracture, nerve damage), not speaking Japanese, impaired consciousness (if difficult to assess). Complications of psychiatric disorders, history of blood disorders.

Design outcomes

Primary

MeasureTime frame
low back pain and lower limb pain intensity (Numerical Rating Scale (NRS): 0-10) up to 48 hours postoperatively.

Secondary

MeasureTime frame
(1) Postoperative numbness in the lower limb (numbness score: 0-3) (2) Dose of fentanyl by iv-PCA (3) Number of times of administration of adjuvant analgesics (4) Number of points of nausea and vomiting (5) Relationship between time to surgery and pain

Countries

Japan

Contacts

Public ContactNao Fujita

Keiyu Orthopedic Hospital Director of a hospital

nao.fjt@gmail.com0276-49-9000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026