The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty

Study Overview
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Brief Summary
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the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.

Official Title
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the Effect of Adding Pregabalin on the Onset and the Duration of Spinal Anesthesia and on the Postoperative Analgesia

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Pregabalin 150mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the ages of 40 and 70 years height 155-170 cm American Society of Anesthesiologists grade I or II . patients underwent total knee arthroplasty under spinal anesthesia Exclusion Criteria: patients known to be allergic to any medicines. patients had a history of drug or alcohol abuse. patients were taking opioids or sedative medications, patients Inability to communicate with investigators to evaluate the postoperative pain patients were in need for postoperative ICU hospitalization . patients had a history of psychiatric conditions. Patients with a history of taking pregabalin or gabapentin .

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: pregabalin group<br>Two hours before surgery, the pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery. | Drug: Pregabalin 150mg<br>* pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery<br>|
| Active Comparator: placebo group<br>The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery . | Drug: Placebo<br>* The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of spinal anaesthesia | seventy participants undergoing elective total knee arthroplasty under spinal anesthesia half of them took placebo and the other half took 150 mg pregabalin two hours before the procedure and calculate the time from the base line to the onset of anesthesia. Our primary outcome is to assess the onset of spinal anesthesia. to detect the onset of spinal anaesthesia | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time | Recovery time from the sensory blockade (2-dermatome regression of anesthesia from the maximum level). | three months | 
| motor block duration | the time for return to Bromag 2 (the patient is able to move knees and ankles). | three months | 
| postoperative analgesia | • Postoperative pain will be assessed by the patient using the visual analog scale in the first 24 hour(VAS, 0=no pain; 10=worst possible pain) every 2 hours up to 24 hours after the operation. | three months. |