NCT01370915

Perioperative Administration of Pregabalin for Pain After Septoplasty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deviated Nasal Septum

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2011-06-10
• Last updated: 2011-06-10

Locations

1 site across 1 country: South Korea