Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?

Study Overview
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Brief Summary
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The investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same points.

Official Title
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Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?

Conditions
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Anterior Cruciate Ligament (ACL) Reconstruction

Intervention / Treatment
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* Drug: pregabalin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 20-65 years physical condition type I or II in ASA (American Society of Anesthesiology) Exclusion Criteria: patients of ASA classification 3 or more with a history of cardiovascular or respiratory disease 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

Ages Eligible for Study
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Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Candidate for arthroscopic ACL reconstruction are divided into two groups of pregabalin and placebo with 48 patients in each group. The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose and a placebo is administered in control group.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Drug: pregabalin<br>* The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.<br>|
| Placebo Comparator: placebo group<br> | Drug: placebo<br>* The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores | Visual analog scale (VAS) score = 0-100 mm | 12 hours after surgery | 
| Postoperative pain scores | Visual analog scale (VAS) score = 0-100 mm | 24 hours after surgery | 
| Postoperative pain scores | Visual analog scale (VAS) score = 0-100 mm | 36 hours after surgery | 
| Postoperative pain scores | Visual analog scale (VAS) score = 0-100 mm | 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption |  | the first 48 hours after surgery |