Combining Oxycodone and Pregabalin for Chronic Pain After Spinal Surgery
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial
This study is testing if combining oxycodone and pregabalin can help people with chronic pain after spinal surgery feel better compared to other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05795478 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oxycodone combined with pregabalin on chronic postoperative pain in patients undergoing spinal surgery. It aims to determine the efficacy and safety of this combination compared to other treatment regimens, including placebo. The study employs a randomized-controlled, factorial design to assess how well these medications can manage pain that persists after surgery. The trial seeks to fill a gap in current pain management strategies for patients experiencing chronic pain following spinal procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective spinal surgery and meet specific health criteria.
Not a fit: Patients with a history of drug abuse, severe health conditions, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for patients recovering from spinal surgery.
How similar studies have performed: While oxycodone is commonly used for acute pain, the combination with pregabalin for chronic postoperative pain is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient undergoing elective spinal surgery * Ages equal to or more than 18 years old * ASA I-III * Signed informed consent Exclusion Criteria: * Previous allergic history to gabapentinoids or oxycodone; * Patients with aphasia or inability to cooperate with scales assessments; * Patients with a diagnosed history of psychiatric disorder; * Known severe insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure); * Patients treated with gabapentin/pregabalin in the last three months; * History of drug abuse; * Body Mass Index more than 35 kg/㎡; * Pregnant or breastfeeding woman.
Where this trial is running
Beijing
- Beijing Tiantan Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Ruquan Han, M.D., Ph D.
- Email: ruquan.han@ccmu.edu.cn
- Phone: 8610-59976660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.