NCT05795478

Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery

Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Post Operative Pain
• Oxycodone
• Pregabalin
• Postoperative Complications

Interventions

Type	Name	Description
DRUG	Oxycodone and Pregabalin	Oxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1\~7,75mg QD for POD8\~14
DRUG	Oxycodone and placebo capsules	Oxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point
DRUG	Pregabalin and NS	Pregabalin: 150mg preoperatively, 75mg BID for POD1\~7,75mg QD for POD8\~14 NS: Equal volume NS for 3 days postoperatively
DRUG	placebo capsules and NS	placebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively

Timeline

• Start date: 2023-10-24
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-04-03
• Last updated: 2024-08-01

Locations

1 site across 1 country: China