Perioperative Administration of Pregabalin for Pain After Septoplasty

Study Overview
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Brief Summary
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Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Persons who scheduled for elective septoplasty under general anesthesia were randomly assigned to groups that received either pregabalin (150 mg twice) or placebo, one hour before surgery and 12 hours after the initial dose. Assessments of pain (verbal numerical rating scale) and side effects were performed at one, six, 12, and 24 hours postoperatively.

Detailed Description
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Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate the efficacy and safety of pregabalin for reducing postoperative pain in patients after septoplasty. Patients will be randomly assigned to one of two groups to receive either pregabalin (Lyrica®, Pfizer, Inc.) or placebo (vitamin complex). According to their assigned study group, patients received either pregabalin (75 mg) or placebo twice, one hour before surgery and 12 hours after the initial dose. The assessment of pain and side effects, such as nausea and vomiting, headache, dizziness, sedation, and blurred vision, were made at one, six, 12, and 24 hours postoperatively.

Official Title
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Perioperative Administration of Pregabalin for Pain After Septoplasty

Conditions
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Deviated Nasal Septum

Intervention / Treatment
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* Drug: Pregabalin (Lyrica)
* Drug: Vitamin complex (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 ≥ and ≤ 65 years Patients with nasal packing after septoplasty Exclusion Criteria: previous septal surgery history postoperative complications including septal hematoma, bleeding ets. Current therapy with pregabalin, gabapentin, or any opioid Renal insufficiency History of seizure disorder

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br>Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later | Drug: Pregabalin (Lyrica)<br>* Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later<br>* Other names: pregabalin;|
| Placebo Comparator: Placebo<br>Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later | Drug: Vitamin complex (placebo)<br>* Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later<br>* Other names: placebo, vitamin complex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) |  | postoperative 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness |  | postoperative 1, 6, 12, 24 hours | 
| The number of patients who required additional analgesics during admission |  | postoperative 1,6,12,24 hour | 
| Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) |  | postoperative 1, 6, 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, nasal septum surgery, pregabalin