Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.

Study Overview
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Brief Summary
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Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.

Official Title
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Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.

Conditions
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Esketamine, Pregabalin, Acute Postoperative Pain, Neurosurgical Procedures, Perioperative Complication, Spinal Cord Neoplasms

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing elective spinal cord neoplasms resection; 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
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation | The primary outcome was the proportion of patients with acute moderate-to-severe postsurgical pain during the 48-h postoperative period (defined as a VAS score ≥ 40 mm). | 48 hours after operation |