Perioperative Administration of Pregabalin for Pain After Septoplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01370915
First received: April 20, 2011
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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 Intervention
Deviated Nasal Septum
Drug: Pregabalin (Lyrica)
Drug: Vitamin complex (placebo)

Study Type: Interventional
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
Official Title: Perioperative Administration of Pregabalin for Pain After Septoplasty

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) [ Time Frame: postoperative 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness [ Time Frame: postoperative 1, 6, 12, 24 hours ] [ Designated as safety issue: No ]
  • The number of patients who required additional analgesics during admission [ Time Frame: postoperative 1,6,12,24 hour ] [ Designated as safety issue: No ]
  • Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) [ Time Frame: postoperative 1, 6, 12 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 20, 2011
Last Updated: June 9, 2011
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Nose Deformities, Acquired
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Gamma-Aminobutyric Acid
Pregabalin
Vitamins
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014