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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Post Operative Pain, Oxycodone, Pregabalin, Postoperative Complications

Intervention / Treatment
-----------------
* Drug: Oxycodone and Pregabalin
* Drug: Oxycodone and placebo capsules
* Drug: Pregabalin and NS
* Drug: placebo capsules and NS


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined group<br>Oxycodone+Pregabalin | Drug: Oxycodone and Pregabalin<br>* Oxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1 7,75mg QD for POD8 14<br>|
| Other: Oxycodone group<br>Oxycodone+placebo capsules | Drug: Oxycodone and placebo capsules<br>* Oxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point<br>|
| Other: Pregabalin group<br>NS+Pregabalin | Drug: Pregabalin and NS<br>* Pregabalin: 150mg preoperatively, 75mg BID for POD1 7,75mg QD for POD8 14 NS: Equal volume NS for 3 days postoperatively<br>|
| Placebo Comparator: Control group<br>NS+placebo capsules | Drug: placebo capsules and NS<br>* placebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |