Perioperative Administration of Pregabalin for Pain After Septoplasty

Samsung Medical Center100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

100

Conditions

Deviated Nasal Septum

Interventions

Pregabalin (Lyrica)DRUG

Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later

Vitamin complex (placebo)DRUG

Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)

Time frame: postoperative 24 hrs

Secondary Outcomes

The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness

Time frame: postoperative 1, 6, 12, 24 hours

The number of patients who required additional analgesics during admission

Time frame: postoperative 1,6,12,24 hour

Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)

Time frame: postoperative 1, 6, 12 hours

Data from ClinicalTrials.gov

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