Perioperative Administration of Pregabalin for Pain After Septoplasty

June 9, 2011 updated by: Samsung Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin
Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later
Drug: Pregabalin (Lyrica)
Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later
Other Names:
  • pregabalin
Placebo Comparator: Placebo
Patients receive oral Placebo(Vitamin complex) 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
Other Names:
  • placebo, vitamin complex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
Time Frame: postoperative 24 hrs
postoperative 24 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness
Time Frame: postoperative 1, 6, 12, 24 hours
postoperative 1, 6, 12, 24 hours
The number of patients who required additional analgesics during admission
Time Frame: postoperative 1,6,12,24 hour
postoperative 1,6,12,24 hour
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
Time Frame: postoperative 1, 6, 12 hours
postoperative 1, 6, 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Hun Jong Dhong, MD, PhD, Samsung Medical Center, Department of Otorhinolaryngoloty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-06-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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