Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

Study Overview
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Brief Summary
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Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia

Detailed Description
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One hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group C (n = 31, placebo), group P (n = 33, pregabalin), group PD (n = 29, pregabalin and dexmedetomidine) or group D (n = 31, dexmedetomidine). One hour before spinal anesthesia, patients received pregabalin 150 mg or placebo orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same calculated volume of normal saline till completion of the surgery. Clinically relevant pain for 24 h after surgery including time to first analgesic request visual analog scale (VAS), ketorolac dose, and patient controlled analgesics (PCA) volume consumed were recorded.

Official Title
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The Effect of the Combination of Pregabalin and Dexmedetomidine on the Management of Postoperative Pain in Patients Undergoing Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) Under Spinal Anesthesia

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Dexmedetomidine
* Other: Placebo
* Drug: Pregabalin and dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II Aged 18-75 years One hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia Exclusion Criteria: Pregnant Allergic and/or contraindicated to the study drugs American Society of Anesthesiologists (ASA) score III and above Having drug Alcohol addiction Renal failure Diabetes mellitus Epilepsy currently using opioids for chronic pain and/or any of the drugs studied.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Group PD<br>combination of pregabalin and dexmedetomidine | Drug: Pregabalin and dexmedetomidine<br>* One hour before spinal anesthesia, patients received pregabalin 150 mg orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery.<br>* Other names: study drugs;|
| Active Comparator: Group P<br>pregabalin +placebo | Drug: Pregabalin<br>* One hour before spinal anesthesia, patients received pregabalin 150 mg capsule orally and the same calculated volume of normal saline till completion of the surgery<br>* Other names: Lyrica;|
| Active Comparator: Group D<br>placebo + dexmedetomidine | Drug: Dexmedetomidine<br>* One hour before spinal anesthesia, patients received placebo and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery<br>* Other names: precedex;|
| Placebo Comparator: Group C<br>placebo + placebo | Other: Placebo<br>* One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient controlled analgesics (PCA) volume | Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery | For 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first analgesic request | time to first analgesic request for 24 hours after surgery | for 24 hours | 
| visual analog scale (VAS) | The VAS consisted of a straight line with the left end of the line representing no pain and the right end of the line representing the worst pain. Patients were asked to mark the position on the line corresponding to their perception of pain. The VAS scores for pain at rest and on movement were measured at intervals of 24, and 48 hours after surgery | for 24 hours | 
| ketorolac dose | ketorolac dose for 24 hours after surgery | for 24 hours | 
| adverse effects | Perioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively | within the first 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregabalin, dexmedetomidine, postoperative pain