Esketamine Combined With Pregabalin on CPSP in Spinal Patients.

Study Overview
=================
Brief Summary
-----------------
Chronic postsurgical pain has become one of the most common complications of surgery. The quality of life will be impacted once the postsurgical patients are combined with persistent pain. What's more, the postsurgical pain may increase other adverse outcomes. It's important to find a better way to keep the postsurgical patients away from postoperative pain. Esketamine and pregabalin have become potentially effective drugs on CPSP.

Official Title
-----------------
Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients Undergoing Primary Spinal Tumor Surgery.

Conditions
-----------------
Esketamine, Pregabaline, Chronic Post Operative Pain

Intervention / Treatment
-----------------
* Drug: S-ketamine and pregabalin
* Drug: Normal saline and placebo capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing elective primary spinal tumor surgery; Ages between 18 and 65 years old; American Society of Anaesthesiology (ASA) status I-III; Signed informed consent. Exclusion Criteria: Previous adverse reaction to ketamine, s-ketamine or pregabalin; Patients with a diagnosed history of severe chronic pain; Patients with long-term analgesic treatment(gabapentin/opioids/ketamine); Patients with aphasia or inability to cooperate with the pain assessments; Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure); Patients with a diagnosed history of psychiatric disorder; Patients treated with gabapentin/pregabalin in the last three months; Drug abuse; Body mass index (BMI) > 35 kg/m2 ; Pregnancy or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-ketamine and pregabalin<br> | Drug: S-ketamine and pregabalin<br>* Drug: Pregabalin 150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7 days(POD1-7), followed by dose reduction to 75mg once daily for 7 days(POD8-14) Drug: S-ketamine infusion 0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous infusion for 48 h<br>|
| Placebo Comparator: Normal saline and placebo capsule<br> | Drug: Normal saline and placebo capsule<br>* Drug: Placebo capsules Two placebo capsules (2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days Drug: Normal saline 0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients with chronic postsurgical pain during 3 months after operation | The primary outcome was the proportion of patients with CPSP during the 3-month postoperative period (defined as a NRS score ≥ 3). | 3 months postoperatively |