NCT05795478 Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery
| NCT ID | NCT05795478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Chronic Post Operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 264 participants in total. It began in 2023-10-24 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic postoperative pain is one of the common perioperative complications, which seriously affects the prognosis of patients. Currently, no specific perioperative pain management strategy has been found to be effective in preventing and treating chronic postoperative pain in patients undergoing spinal surgery. At present, oxycodone has been widely recognized in different surgical populations for the control of acute postoperative pain, but its contribution to chronic postoperative pain remains unknown. Meanwhile, whether pregabalin can reduce the occurrence of chronic postoperative pain remains controversial, and whether the combination of the two drugs can control the occurrence of chronic postoperative pain in a more comprehensive way remains unknown. Therefore, we intend to conduct this randomized-controlled, factorial design study to determine the efficacy and safety of oxycodone combined with pregabalin in the treatment of chronic postoperative pain in patients undergoing spinal surgery.
Eligibility 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.
Contact & Investigator
Ruquan Han, M.D., Ph D.
STUDY CHAIR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT05795478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05795478 currently recruiting?
Yes, NCT05795478 is actively recruiting participants. Contact the research team at ruquan.han@ccmu.edu.cn for enrollment information.
Where is the NCT05795478 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05795478 clinical trial?
NCT05795478 is sponsored by Beijing Tiantan Hospital. The principal investigator is Ruquan Han, M.D., Ph D. at Beijing Tiantan Hospital. The trial plans to enroll 264 participants.