Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures.
Hans J Gerbershagen, Sanjay Aduckathil, Albert J M van Wijck...
https://pubmed.ncbi.nlm.nih.gov/23392233Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06087510
Impact of Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia on Long-term Outcomes After Scoliosis Correction Surgery: Follow-up of a Randomized Trial
Led by Peking University First Hospital · Updated on 2025-07-30
312
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic postsurgical pain (CPSP) is pain that begins or worsens after surgery and lasts longer than three months, affecting up to 75% of patients after spinal correction surgery. This trial evaluates different doses of esketamine combined with dexmedetomidine as supplements to opioids for pain relief after scoliosis correction surgery. The study aims to see if higher esketamine doses can improve pain control and reduce chronic pain over time. Participants receive patient-controlled intravenous analgesia with varying doses of esketamine (50 mg, 100 mg, or 150 mg) combined with a fixed dose of dexmedetomidine and sufentanil. The analgesia is delivered through programmed boluses and background infusion after surgery. This trial compares three groups receiving low, medium, or high esketamine doses to assess long-term outcomes after surgery. During the study, participants are monitored for chronic postsurgical pain at 3, 6, and 12 months after surgery. Researchers assess pain severity, sleep quality, depression levels, quality of life, and use of pain medications. This follow-up monitors the effectiveness of the treatments and overall recovery over one year, with safety and event-free survival also tracked.
CONDITIONS
Brief Title
Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older and weighing at least 40 kg
- Scheduled for scoliosis correction surgery with pedicle screw fixation
- Require patient-controlled intravenous analgesia after surgery
You will not qualify if you...
- Preoperative sick sinus syndrome or severe slow heart rate below 50 beats per minute
- Atrioventricular block grade II or higher without pacemaker
- Congenital heart disease or serious arrhythmia with New York Heart Association class III or above
- Moderate or severe obstructive sleep apnea diagnosed before surgery or high STOP-Bang score
- History of hyperthyroidism or pheochromocytoma
- History of schizophrenia, epilepsy, or myasthenia gravis
- Severe liver dysfunction (Child-Pugh grade C) or severe kidney dysfunction requiring dialysis
- American Society of Anaesthesiologists grade IV or higher
- Communication barriers
- Other conditions considered unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Postoperative period as per patient-controlled analgesia regimen
Participants receive different doses of esketamine combined with dexmedetomidine and sufentanil through patient-controlled intravenous analgesia after scoliosis correction surgery for supplemental pain relief.
1 baseline visit and multiple visits during hospital stay for analgesia management
Long-term Monitoring
Duration - Up to 12 months after surgery
Participants are followed for up to 12 months after surgery to assess chronic postsurgical pain, sleep quality, depression severity, quality of life, and event-free survival.
Visits at 3, 6, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
Beijing University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
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Research Team
D
Dong-Xin Wang, MD, PhD
F
Fan Cui, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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V Wylde, J Dennis, A D Beswick...
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https://pubmed.ncbi.nlm.nih.gov/21348566Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists.
Eric S Schwenk, Eugene R Viscusi, Asokumar Buvanendran...
https://pubmed.ncbi.nlm.nih.gov/29870457Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists.
Steven P Cohen, Anuj Bhatia, Asokumar Buvanendran...
https://pubmed.ncbi.nlm.nih.gov/29870458Antidepressant Efficacy and Tolerability of Ketamine and Esketamine: A Critical Review.
P Molero, J A Ramos-Quiroga, R Martin-Santos...
https://pubmed.ncbi.nlm.nih.gov/29736744Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study.
Carla M Canuso, Jaskaran B Singh, Maggie Fedgchin...
https://pubmed.ncbi.nlm.nih.gov/29656663Repeated S-ketamine infusions in therapy resistant depression: a case series.
Felix Segmiller, Tobias Rüther, Andrea Linhardt...
https://pubmed.ncbi.nlm.nih.gov/23893490