Using low-dose S-ketamine to reduce pain after spine fusion surgery
Analgesic Effects of Low-dose S-ketamine in Patients Undergoing Major Spine Fusion Surgery: A Double-blinded, Randomized Controlled Trial
PHASE4 · Peking University First Hospital · NCT04964219
This study is testing if a low dose of S-ketamine can help reduce pain after spine fusion surgery and lower the need for opioids.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University First Hospital (other) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04964219 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the analgesic effects of perioperative S-ketamine infusion in patients undergoing major multi-segment spine fusion surgery. It aims to determine if S-ketamine can effectively decrease postoperative pain intensity, which is often moderate-to-severe despite current opioid-based pain management strategies. The study will compare the outcomes of patients receiving S-ketamine to those receiving a placebo, focusing on pain scores and opioid consumption in the postoperative period. The trial is designed to enhance recovery and prevent chronic pain by improving pain control while minimizing opioid use.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 scheduled for multi-segment spine fusion surgery who agree to postoperative patient-controlled analgesia.
Not a fit: Patients with severe cardiovascular, hepatic, or renal conditions, or those with a history of certain neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and recovery for patients undergoing spine fusion surgery.
How similar studies have performed: Previous studies have shown promising results with ketamine for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged between 18 and 80 years. * Scheduled to undergo multi-segment (≥2) spine fusion surgery. * Agreed to receive postoperative patient-controlled analgesia. Exclusion Criteria: * Refused to participant in this trial. * Poor blood pressure control in those with hypertension (BP \>160/100 mmHg in the ward). * Previous history of hyperthyroidism or pheochromocytoma. * Previous history of schizophrenia, epilepsy or Parkinson disease. * History of sick sinus syndrome, bradycardia (HR \<50 beat per min), or atrioventricular block of grade II or higher without pacemaker. * Severe heart dysfunction (New York Heart Association functional classification 4), hepatic insufficiency (Child-Pugh grade C), renal insufficiency (serum creatinine of 442 μmol/L or above, or requirement of renal replacement therapy), or ASA classification IV or above. * Unable to complete preoperative assessment due to severe dementia or language barrier. * Any other conditions that were considered unsuitable for the study participation.
Where this trial is running
Beijing, Beijing
- Beijing University First Hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Dong-Xin Wang, MD, PhD
- Email: wangdongxin@hotmail.com
- Phone: +8610-83572784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: S-ketamine, Postoperative Analgesia, Spine Fusion