Perioperative Administration of Pregabalin for Pain After Septoplasty

Samsung Medical Center

Status: Unknown

Conditions: Deviated Nasal Septum

Treatments: Drug: Pregabalin (Lyrica); Drug: Vitamin complex (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT01370915

2010-06-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Pregabalin

Experimental group

Description:

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

Treatment:

Drug: Pregabalin (Lyrica)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Vitamin complex (placebo)