Perioperative Administration of Pregabalin for Pain After Septoplasty

NCT01370915 | Unknown

• 1 other identifier: 2010-06-012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Deviated Nasal Septum

Keywords

postoperative pain, nasal septum surgery, pregabalin

Outcome Measures

Primary Outcomes (1)

• Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)

  postoperative 24 hrs

Secondary Outcomes (3)

• The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness

  postoperative 1, 6, 12, 24 hours

• The number of patients who required additional analgesics during admission

  postoperative 1,6,12,24 hour

• Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)

  postoperative 1, 6, 12 hours

Study Arms (2)

Pregabalin

EXPERIMENTAL

Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later

Drug: Pregabalin (Lyrica)

Placebo

PLACEBO COMPARATOR

Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later

Drug: Vitamin complex (placebo)

Interventions

Pregabalin (Lyrica) DRUG

Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later

Also known as: pregabalin

Pregabalin

Vitamin complex (placebo) DRUG

Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later

Also known as: placebo, vitamin complex

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 ≥ and ≤ 65 years
• Patients with nasal packing after septoplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Hun Jong Dhong, MD, PhD

  Samsung Medical Center, Department of Otorhinolaryngoloty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: June 10, 2011
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

KR (1)