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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05795478
• Other study ID #: sunQKT6660
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, M.D., Ph D.
• Phone: 8610-59976660
• Email: ruquan.han[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: December 31, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oxycodone
• Pain, Postoperative
• Postoperative Complications
• Pregabalin

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of CPSP	The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score >3 (0~10).	3 months after surgery