Deviated Nasal Septum
Conditions
Keywords
postoperative pain, nasal septum surgery, pregabalin
Brief summary
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
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.
Interventions
Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later
Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) | postoperative 24 hrs |
Secondary
| Measure | Time frame |
|---|---|
| Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) | postoperative 1, 6, 12 hours |
| The number of patients who required additional analgesics during admission | postoperative 1,6,12,24 hour |
| The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness | postoperative 1, 6, 12, 24 hours |
Countries
South Korea
Outcome results
None listed