Interventional pain management for failed back surgery syndrome.
Arif Hussain, Michael Erdek
https://pubmed.ncbi.nlm.nih.gov/23374545/Actively Recruiting
Led by Peking University First Hospital · Updated on 2025-07-30
312
Participants Needed
1
Research Sites
39 weeks
Total Duration
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
Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes
D
Dong-Xin Wang, MD, PhD
F
Fan Cui, MD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Peking University First Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Have more questions? Get in touch with our team for quick support
Arif Hussain, Michael Erdek
https://pubmed.ncbi.nlm.nih.gov/23374545/Rikke Vibeke Nielsen, Jonna Storm Fomsgaard, Lone Nikolajsen...
https://pubmed.ncbi.nlm.nih.gov/30246357/L S Stone, L B MacMillan, K F Kitto...
https://pubmed.ncbi.nlm.nih.gov/9278550/Rikke Vibeke Nielsen, Jonna Storm Fomsgaard, Hanna Siegel...
https://pubmed.ncbi.nlm.nih.gov/28067693/Ming Li, Chuan-Feng Wang, Su-Xi Gu...
https://pubmed.ncbi.nlm.nih.gov/19455008/Z C Hu, G Xu, X W Zhang...
https://pubmed.ncbi.nlm.nih.gov/32594705/Kenneth M C Cheung, Alpaslan Senkoylu, Ahmet Alanay...
https://pubmed.ncbi.nlm.nih.gov/17471100/Pierre A Clavien, Jeffrey Barkun, Michelle L de Oliveira...
https://pubmed.ncbi.nlm.nih.gov/19638912/Ki Hwa Lee, Soo Jee Lee, Jae Hong Park...
https://pubmed.ncbi.nlm.nih.gov/32443302/Steven P Cohen, Anuj Bhatia, Asokumar Buvanendran...
https://pubmed.ncbi.nlm.nih.gov/29870458/Peking University First Hospital
Lead Sponsor