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Deviated Nasal Septum | Perioperative Administration of Pregabalin for Pain After Septoplasty

Deviated Nasal Septum research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Deviated Nasal Septum

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Pregabalin (Lyrica)Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PregabalinPatients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later

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

Study Status

Unknown status

Start Date: September 2010

Completed Date: December 2011

Phase: N/A

Type: Interventional

Design:

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

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

Study sponsors, principal investigator, and references

Principal Investigator: Hun Jong Dhong, MD, PhD

Lead Sponsor: Samsung Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01370915

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