Perioperative Administration of Pregabalin for Pain After Septoplasty

Not Applicable

• Conditions: Deviated Nasal Septum
• Interventions: Drug: Pregabalin (Lyrica); Drug: Vitamin complex (placebo)

• Registration Number: NCT01370915
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-04-20
• Status Verified: 2011-06
• Study First Submitted QC: 2011-06-09
• Last Update Submitted: 2011-06-09
• Study First Posted: 2011-06-10
• Last Update Posted: 2011-06-10
• Primary Completion: 2011-11
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin	Pregabalin (Lyrica)	Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later
Placebo	Vitamin complex (placebo)	Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later

Primary Outcome Measures

Name	Time	Method
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)	postoperative 24 hrs

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of