Perioperative Administration of Pregabalin for Pain After Septoplasty

Deviated Nasal Septum Clinical Trial

Official title:

Perioperative Administration of Pregabalin for Pain After Septoplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01370915
• Other study ID #: 2010-06-012
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2011
• Last updated: June 9, 2011
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Deviated Nasal Septum

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)		postoperative 24 hrs	No
Secondary	The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness		postoperative 1, 6, 12, 24 hours	No
Secondary	The number of patients who required additional analgesics during admission		postoperative 1,6,12,24 hour	No
Secondary	Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)		postoperative 1, 6, 12 hours	No