Pregabalin is an Effective Treatment for Acute Postoperative Pain Following Spinal Surgery Without Major Side Effects

Study Overview
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Brief Summary
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The objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.

Detailed Description
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Patients experience considerable postoperative pain after spine surgery. Because the spine is located at the center of the body and supports body weight, severe postoperative pain hinders upper body elevation and gait which can lead to various complications such as pulmonary deterioration or pressure sores. It is important to effectively control postoperative pain to prevent such complications. Gabanoids are widely used as preemptive multimodal analgesia while their effects and side effects are known to be dose dependent. The objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.

Official Title
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Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery

Conditions
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Postoperative Pain, Pregabalin, Spine Surgery, Adverse Reaction to Pregabalin

Intervention / Treatment
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* Drug: Pregabalin 25 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient undergoing spine surgery at out institution for degenerative lumbar disorder. Exclusion Criteria: ASA classification over 2 Patients with dizziness or frequent headache Active alcohol or drug usage Intake of any analgesics daily or 48 hours before surgery Impaired renal and/or hepatic function Diagnosed and being treated for anxiety or depression disorders Coverage from worker's compensation insurance or car insurance.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours | Drug: Placebo<br>* Patients are given 0 to 3 capsules per administration according to their allocated group.<br>|
| Experimental: Pregabalin 25mg<br>1 capsule of Kabalin 25mg Cap and 2 pills of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours | Drug: Pregabalin 25 MG<br>* Patients are given 0 to 3 capsules per administration according to their allocated group.<br>Drug: Placebo<br>* Patients are given 0 to 3 capsules per administration according to their allocated group.<br>|
| Experimental: Pregabalin 50mg<br>2 capsules of Kabalin 25mg Cap and 1 pill of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours | Drug: Pregabalin 25 MG<br>* Patients are given 0 to 3 capsules per administration according to their allocated group.<br>Drug: Placebo<br>* Patients are given 0 to 3 capsules per administration according to their allocated group.<br>|
| Experimental: Pregabalin 75mg<br>3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours | Drug: Pregabalin 25 MG<br>* Patients are given 0 to 3 capsules per administration according to their allocated group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Change of Visual analogue scale (VAS) pain score | Arrival at the general ward | 
| Pain intensity | Change of Visual analogue scale (VAS) pain score | 6hours after surgery | 
| Pain intensity | Change of Visual analogue scale (VAS) pain score | 24hours after surgery | 
| Pain intensity | Change of Visual analogue scale (VAS) pain score | 48hours after surgery | 
| Pain intensity | Change of Visual analogue scale (VAS) pain score | 72hours after surgery | 
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | Arrival at the general ward | 
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 6hours after surgery | 
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 24hours after surgery | 
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 48hours after surgery | 
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 72hours after surgery | 
| Rescue analgesic usage | Frequency of rescue analgesic administered | Arrival at the general ward | 
| Rescue analgesic usage | Frequency of rescue analgesic administered | 6hours after surgery | 
| Rescue analgesic usage | Frequency of rescue analgesic administered | 24hours after surgery | 
| Rescue analgesic usage | Frequency of rescue analgesic administered | 48hours after surgery | 
| Rescue analgesic usage | Frequency of rescue analgesic administered | 72hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting due to IV PCA usage | Incidence and frequency of nausea and vomiting event due to IV PCA usage | From arrival at general ward after sugery for 72 hours, subdivided into 4 periods (1-6hours, 6-24hours, 24-48hours, 48-72hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Pain, pregabalin, Spine surgery, adverse reaction to pregabalin