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Perioperative Administration of Pregabalin for Pain After Septoplasty

Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01370915
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
15
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pregabalin (Lyrica)
  • Drug: Vitamin complex (placebo)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Perioperative Administration of Pregabalin for Pain After Septoplasty
Study Start Date :
Sep 1, 2010
Anticipated Primary Completion Date :
Nov 1, 2011
Anticipated Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) [postoperative 24 hrs]

    Secondary Outcome Measures

    1. The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness [postoperative 1, 6, 12, 24 hours]

    2. The number of patients who required additional analgesics during admission [postoperative 1,6,12,24 hour]

    3. Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) [postoperative 1, 6, 12 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01370915
    Other Study ID Numbers:
    • 2010-06-012
    First Posted:
    Jun 10, 2011
    Last Update Posted:
    Jun 10, 2011
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    postoperative pain, nasal septum surgery, pregabalin
    Additional relevant MeSH terms:
    Vitamins
    Pregabalin

    Study Results

    No Results Posted as of Jun 10, 2011