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Efficacy of intraoperative Nitrous Oxide use on postoperative pain in patients with cervical spinal cord injury: a randomized controlled trial

Efficacy of intraoperative Nitrous Oxide use on postoperative pain in patients with cervical spinal cord injury

80

The mean (SD) age was 70.34 (12.07) years, and approximately two-thirds of the participants were male. No significant differences in body composition or primary disease distribution were detected between groups. The leading cause of SCI was a fall, consistent with findings from a national survey of traumatic SCI in Japan.14 Intraoperative use of opioids and time from onset to surgery did not differ significantly between the groups. Postoperative analgesic use did not differ significantly between the groups.

A total of 92 patients were invited to participate; 12 were excluded based on the inclusion and exclusion criteria (seven did not meet the inclusion criteria and five declined to participate). The remaining 80 patients were randomly assigned to the air or N2O groups, with 40 patients in each group. A total of 21 patients were excluded before the 6M postoperative period: eight patients were lost to follow-up (Air/N2O: 4/4), four could not be assessed due to cognitive decline (Air/N2O:1/3), one patient in each group required reoperation, one patient in the N2O group died and one patient in each group received intraoperative use of another NMDA receptor antagonist. In total, 59 patients completed the 6M assessment and were included in the mITT analysis.

Primary: No significant difference was found in the incidence of PONV, sore throat, or hoarseness between the groups. The incidence of PONV was 29.9% in the Air group and 23.4% in the N2O group. Secondary: The mean (SD) change in resting NRS-P at 1D was -2.69 (4.43) in the Air group and -1.07 (3.89) in the N2O group, with no significant difference between the groups. Furthermore, resting NRS-P levels were not significantly different between the groups at 2W, 3M, or 6M. Neuropathic Pain Assessment: The scores for the two groups at 1D did not differ significantly for either the NRS-N or NPSI. In the N2O group, the NRS-N score was reduced only at 6M [Air: 4.72 (2.79), N2O: 2.90 (2.50), P = .01]. Anxiety, Depression, Quality of Life, and PGIC: No significant differences in EQ-5D-5L scores were detected between groups at any time point. At 2W, the Air group had higher HADS-Anxiety (P = .0470) and HADS-Depression (P = .0402). Although PGIC showed no differences between the groups at 2W and 3M, PGIC improvement was higher in the N2O group at 6M (P = .032). Relationship Between Time to Surgery and Pain Intensity: No strong correlation was found between the time to surgery and resting NRS-P at 1D (r = 0.12), 2W (r = 0.31), 3M (r = 0.35), and 6M (r = 0.47).

The mean (SD) preoperative resting NRS-P was 6.24 (3.28) in the Air group and 6.17 (3.71) in the N2O group, with no significant difference between groups. The mean resting NRS-P was higher in the N2O group at 1D (P = .021), whereas it was higher in the air group at 6M (P = .030).

Intraoperative N2O inhalation did not suppress early postoperative pain in patients with cervical spinal cord injury, but it may suppress the chronic neuropathic pain.

June. 06, 2025

No

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https://jrct.mhlw.go.jp/latest-detail/jRCT1031210580

Sugimoto Mayu

Saitama Medical Center, Saitama Medical University

1981 Kamoda, Kawagoe, Saitama

mayu_h@saitama-med.ac.jp

Sugimoto Mayu

Saitama Medical Center, Saitama Medical University

1981 Kamoda, Kawagoe, Saitama

+81-492283654

mayu_h@saitama-med.ac.jp

Complete

Jan. 25, 2022

Interventional

randomized controlled trial

double blind

no treatment control/standard of care control

parallel assignment

prevention purpose

Patients aged 20 years or older with ASIA classification C or D cervical spinal cord injury who underwent urgent spinal surgery

Pneumothorax , head injury, limb injury : fracture/nerve injury, non-speaking Japanese, impaired consciousness ,Complications of psychiatric disorders :such as suicidal ideation, complications of other trauma, history of blood disorders

Both

Spinal cord injury

After the introduction of anesthesia, assigned to receive 60% nitrous oxide in 40% oxygen or Air-oxygen-sevoflurane during anaesthesia.

Neuropathic pain,Spinal cord injury

nitrous oxide

D013119

D009609

Pain intensity:NRS for the past 24 hours before and after surgery

1.Changes in the range of postoperative neuropathic pain:The range of pain/numbness along the upper limbs dermatome
2. Properties and intensity of neuropathic pain in the past 24 hours :NPSI
3. Psychological state:HADS
4. ADL:EQ5D
5. Degree of improvement:PGIC
6. Relationship between time to surgery and pain

1,2 are assessed at 1D, 2W, 3M, 6M, and 4 to 6 at 2W, 3M, 6M.

+81-49-228-3654

Mar. 03, 2022

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