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Perioperative Administration of Pregabalin for Pain After Septoplasty

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ClinicalTrials.gov Identifier: NCT01370915
Recruitment Status : Unknown
Verified June 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : June 10, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Deviated Nasal Septum Drug: Pregabalin (Lyrica) Drug: Vitamin complex (placebo) Not Applicable

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  (Clinical Trial)
Estimated 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 : September 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

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 Name: 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 Name: placebo, vitamin complex



Primary Outcome Measures :
  1. Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) [ Time Frame: postoperative 24 hrs ]

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


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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370915


Locations
Korea, Republic of
Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital Recruiting
Seoul, Korea, Republic of, 135-710
Contact: JOON HO KIM    82-2-3410-3579    juno0077.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Hun Jong Dhong, MD, PhD Samsung Medical Center, Department of Otorhinolaryngoloty

Responsible Party: Hun Jong Dhong, Professor, Department of Otorhinolaryngology-H&N surgery, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01370915     History of Changes
Other Study ID Numbers: 2010-06-012
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Samsung Medical Center:
postoperative pain, nasal septum surgery, pregabalin

Additional relevant MeSH terms:
Vitamins
Pregabalin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs