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The analgesic effect of oxalidine for acute pain after spinal correction surgery in adults: a single-center, prospective, randomized controlled, non-inferiority study

The analgesic effect of oxalidine for acute pain after spinal correction surgery in adults: a single-center, prospective, randomized controlled, non-inferiority study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093399
Enrollment
Unknown
Registered
2024-12-04
Start date
2024-12-09
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Spinal Correction

Interventions

The Oxalidine group:Oxalidine fumarate, 1.5mg/1.5ml, was drawn into a 5-ml syringe by the study coordinator and diluted to 5ml with 0.9% sodium chloride injection, which was delivered to the PACU anes
Fentanyl group:Fentanyl citrate injection 0.05mg was diluted to 5ml with 0.9% sodium chloride injection, drawn into a 5ml syringe by the study coordinator, and handed to the PACU anesthesiologist for

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, =4 in POstanesthesia care unit; Postoperative patient-controlled intravenous analgesia (PCIA) was used; 6. Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in the study; 2. Patients with sick sinus syndrome, severe sinus bradycardia (heart rate =III; Abnormal electrocardiography (QTcF interval >450 msec for men and >470 msec for women at screening); 3. Patients with preoperative diagnosis of sleep apnea, or STOP-Bang score (Appendix 1) >=3 and HCO3->=28mmol/L; 4. History of hyperthyroidism and pheochromocytoma before surgery; 5. Preoperative schizophrenia, epilepsy, myasthenia gravis and delirium; 6. Severe liver dysfunction (Child-Pugh class C, Annex 2); Severe renal dysfunction (dialysis before operation); ASA grade >=IV; 7. Cannot understand the visual analogue scale or has language communication difficulties; 8. History of opioid allergy; 9. Long-term opioid use (defined as >15 morphine equivalent units/day, > 3 days/week for >1 month within 1 year after surgery); 10. Long-term treatment with non-steroidal anti-inflammatory drugs (NSAID used for >2 weeks daily within 6 months before surgery); 11. Body weight 35kg/m2; 12. Other circumstances deemed inappropriate by the investigator or physician in charge.

Design outcomes

Primary

MeasureTime frame
The difference in pain scores was changed half an hour after the experimental drug was given;

Secondary

MeasureTime frame
Pain score and opioid consumption (PIOC) score at 72 hours;Incidence of POGD 3 days after surgery;The incidence of moderate to severe pain within 72 hours after surgery;NRS was used to evaluate pain at rest and during activity within 3 days after surgery;Total opioid consumption within 3 postoperative days;Quality of postoperative recovery;Cumulative analgesic consumption and rescue analgesic administration within 3 days after surgery;RASS score at each time point within 5 days after surgery;Incidence of delirium within 5 days after surgery;NRS score during the first 5 postoperative nights;Postoperative gastrointestinal function recovery indicators included time to first exhaust, time to first bowel sounds and time to first defecation;Length of postoperative hospital stay;Total duration of analgesia within 30 days after surgery;The incidence of complications (including all-cause death) within 30 days after surgery was analyzed;Pain, quality of life, and orthopedic condition were evaluated 90 days after surgery;

Countries

China

Contacts

Public ContactJinhua Bo

Nanjing Drum Tower Hospital

bojinhua@njglyy.com+86 159 5198 7578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026