Actively Recruiting
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial
Led by Beijing Tiantan Hospital · Updated on 2024-08-01
264
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of oxycodone combined with pregabalin on chronic postoperative pain in patients undergoing spinal surgery. Chronic postoperative pain is a common complication after surgery that seriously impacts patient recovery. The study aims to determine if the combination of these two drugs can better prevent and treat chronic pain after spinal surgery compared to each drug alone or placebo. This is a randomized, double-blinded, factorial design trial sponsored by Beijing Tiantan Hospital. The trial includes four study groups: one receiving both oxycodone and pregabalin, one receiving oxycodone and placebo capsules, one receiving pregabalin and normal saline (NS), and one receiving placebo capsules and NS. Oxycodone is given at 150mg via patient-controlled intravenous analgesia (PCIA) for 3 days after surgery. Pregabalin is given as 150mg before surgery, then 75mg twice daily from postoperative day 1 to 7, and 75mg once daily from day 8 to 14. Placebo capsules and NS are used to match the study drugs in the other groups. Participants will be monitored for the incidence of chronic postoperative pain at 3 months after surgery, which is the primary outcome. The study uses randomization and triple blinding to ensure reliable results. Patients will be followed up to assess safety and effectiveness of the drug combinations. The total participation time covers surgery, postoperative treatment, and follow-up assessments, providing a comprehensive evaluation of pain management strategies after spinal surgery.
CONDITIONS
Brief Title
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient undergoing elective spinal surgery
- Ages equal to or more than 18 years old
- ASA physical status classification I to III
- Signed informed consent
You will not qualify if you...
- Previous allergic history to gabapentinoids or oxycodone
- Patients with aphasia or inability to cooperate with scale assessments
- Patients with a diagnosed history of psychiatric disorder
- Known severe insufficiency of vital organs such as heart failure, renal dysfunction, or hepatic failure
- Patients treated with gabapentin or pregabalin in the last three months
- History of drug abuse
- Body Mass Index more than 35 kg/m²
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive assigned study drugs including oxycodone and/or pregabalin starting preoperatively and continuing postoperatively for up to 14 days.
Daily visits during the first 14 days post surgery
Duration - 3 months after surgery
Participants are monitored for the incidence of chronic postsurgical pain at 3 months after surgery.
1 visit approximately 3 months after surgery
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China, 100070
Actively Recruiting
Research Team
R
Ruquan Han, M.D., Ph D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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