Analgesic Effects of Low-dose S-ketamine in Major Spine Fusion Surgery (NCT04964219) | Clinical Trial Compass
CompletedPhase 4
Analgesic Effects of Low-dose S-ketamine in Major Spine Fusion Surgery
China164 participantsStarted 2022-02-08
Plain-language summary
Despite opioid-based multimodal analgesia, moderate-to-severe pain remains a big problem in patients following multi-segment spinal fusion. As a N-methyl-D-aspartate receptor antagonist, S-ketamine has prominent analgesic effects through activating receptors both in the brain and in the spinal cord, inhibiting the excitatory postsynaptic potential, and thus blunting nociception transmission.
This randomized controlled trial is designed to investigate whether perioperative S-ketamine infusion can decrease pain intensity after major spine fusion surgery.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage of patients with moderate-to-severe pain in the first 48 hours after surgery.