Spine surgery pain breakthrough? drug cocktail aims to stop chronic ache
NCT ID NCT07525999
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a combination of two drugs (dexmedetomidine and esketamine) before and after spine surgery can lower the risk of long-term pain. About 274 adults aged 40-79 having spine surgery will take part. The goal is to see if this approach reduces pain that lasts 3 months or more after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 274 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged \>= 40 years and \< 80 years; 2. Scheduled to undergo elective posterior cervical, thoracic or lumbar spine surgery under general anesthesia, with an expected operative duration \>= 2 hours; 3. Requirement for patient-controlled intravenous analgesia (PCIA) postoperatively. Exclusion Criteria: 1. Severe uncontrolled hypertension preoperatively (baseline ward blood pressure: SBP \> 180 mmHg or DBP \> 110 mmHg); 2. Severe bradycardia (heart rate \<= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, or a history of myocardial infarction within one year, severe heart failure (NYHA class \>= III), or rapid ventricular arrhythmia; 3. Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension; 4. Preoperative history of hyperthyroidism or pheochromocytoma; 5. Inability to communicate preoperatively due to coma, severe dementia, or language impairment; 6. Severe cardiac insufficiency (preoperative LVEF \< 30% or NYHA class IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (preoperative dialysis), or ASA physical status \>= grade IV; 7. Other conditions deemed inappropriate for study participation by the investigator or attending physician.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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Other studies related to the condition(s) this trial covers.
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- Can a Mini-Dose drug combo rescue Post-Surgery sleep for sleep apnea patients?
- Predicting pain: a new model may tailor Post-Surgery relief