Deviated Nasal SeptumNCT01370915
Perioperative Administration of Pregabalin for Pain After Septoplasty
A study testing Pregabalin (Lyrica) in people with Deviated Nasal Septum, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Deviated Nasal Septum
- What is being tested?
- Pregabalin (Lyrica)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 ≥ and ≤ 65 years
- Patients with nasal packing after septoplasty
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital
Seoul, 135-710
JOON HO KIM, 82-2-3410-3579, juno0077.kim@samsung.com
About this study
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.
Read the 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.
- Conditions
- Deviated Nasal Septum
- Being tested
- Pregabalin (Lyrica), Vitamin complex (placebo)
- Keywords
- postoperative pain, nasal septum surgery, pregabalin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin (Lyrica)Drug
Also called pregabalin
Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later
Vitamin complex (placebo)Drug
Also called placebo, vitamin complex
Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later Receives: Drug: Pregabalin (Lyrica) |
| Placebo | Placebo comparator | Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later Receives: Drug: Vitamin complex (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
Measured: postoperative 24 hrs
Secondary outcomes (3)
The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness
Measured: postoperative 1, 6, 12, 24 hours
The number of patients who required additional analgesics during admission
Measured: postoperative 1,6,12,24 hour
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
Measured: postoperative 1, 6, 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionNov 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deviated Nasal SeptumStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hun Jong Dhong, MD, PhD, Principal investigator, Samsung Medical Center, Department of Otorhinolaryngoloty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370915
- Sponsor's protocol ID
- 2010-06-012
- Status last verified
- Jun 2011
- First submitted
- 20 Apr 2011
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Administration of Pregabalin for Pain After Septoplasty
- ClinicalTrials.gov ID
- NCT01370915
- Acronym / sponsor ID
- 2010-06-012
- Conditions
- Deviated Nasal Septum
- Keywords
- postoperative pain, nasal septum surgery, pregabalin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin (Lyrica)Patients receive oral placebo 150 mg 1hour prior to septal surgery, and 12 hours later |
| Placebo | Placebo comparator | Drug: Vitamin complex (placebo)Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20 ≥ and ≤ 65 years
- Patients with nasal packing after septoplasty
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin (Lyrica)Also: pregabalinPatients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later | Drug | Pregabalin |
| Vitamin complex (placebo)Also: placebo, vitamin complexPatients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later | Drug | Placebo |
Primary outcome
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
Time frame: postoperative 24 hrs
3 secondary outcomes
The number of patients with side effects including Nausea and vomiting, sedation, headache, dizziness
Time frame: postoperative 1, 6, 12, 24 hours
The number of patients who required additional analgesics during admission
Time frame: postoperative 1,6,12,24 hour
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS)
Time frame: postoperative 1, 6, 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Otorhinolaryngology H&N surgery, Sungkyunkwan University College of Medicine, Samsung Seoul Hospital
Seoul, South Korea
Hun Jong Dhong, MD, PhD principal investigator
Samsung Medical Center, Department of Otorhinolaryngoloty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin (Lyrica) in people with Deviated Nasal Septum, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (Verbal numerical rating scale, VNRS and Visual Analogue Scale, VAS) (time frame: postoperative 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.