Clinical trial NCT01370915: Perioperative Administration of Pregabalin for Pain After Septoplasty
Official title: Perioperative Administration of Pregabalin for Pain After Septoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deviated Nasal Septum
Keywords: postoperative pain, nasal septum surgery, pregabalin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
timeFrame: postoperative 24 hrs
Secondary outcomes:
measure: The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness
timeFrame: postoperative 1, 6, 12, 24 hours
measure: The number of patients who required additional analgesics during admission
timeFrame: postoperative 1,6,12,24 hour
measure: Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
timeFrame: postoperative 1, 6, 12 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital
Study officials:
affiliation: Samsung Medical Center, Department of Otorhinolaryngoloty
name: Hun Jong Dhong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: