The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy A Prospective, Randomized, Double Blinded, Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Average pain for the previous 24 hour period,
研究概览
简要总结
The primary aims of this study are to determine if treatment with Gabapentin taken systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical treatments reduces post surgical neuropathic pain and discomfort. The investigators main Hypothesis is that gabapentin given prior to and after refractive surgery prevents central sensitization and local allodynia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be at least 18 years of age
- •Subjects must not have any corneal disease or degeneration
- •Subjects must be candidates for LASIK or PRK refractive surgery
排除标准
- •History of topical ocular medications within 4 weeks prior to enrollment
- •History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment
- •History of a previous refractive surgery
- •History of previous diagnosis of corneal disease, degeneration, or glaucoma
- •History of autoimmune disease
- •History of oral anti-histamines currently or within 1 week of study enrollment
- •History of systemic anti-inflammatory or pain medication currently or within 4 weeks of study enrollment
- •Use of oral diuretics or betablocker currently or within 1 week of study enrollment
- •Current diagnosis of dry eye
- •Patients whose Best corrected vision is less than 20/20
- •Patients whose target post operative refraction is not plano
- •Pregnant and lactating
研究组 & 干预措施
GABAPENTIN
Group of patients treated with oral gabapentin
干预措施: Gabapentin (Drug)
PLACEBO
Group given the placebo capsules
干预措施: Sugar pill (Drug)
结局指标
主要结局
Average pain for the previous 24 hour period,
时间窗: assesed at 24 hours
Numerical visual scale questionnaire, a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded
Maximum pain intensity for the previous 24 hour period
时间窗: Assesed at 72 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Pain at moment of examination
时间窗: postoperative day 7
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain since last examination
时间窗: Assesed on postopertive day 7
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Maximum pain intensity for the last 24 hour period
时间窗: Assesed at 96 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
pain on examination
时间窗: 96 hours ostoiperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain for the previous 24 hour period
时间窗: Assesed at 48 hours
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain during the previous 24 hour period
时间窗: Assesed at 72 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Average pain for the last 24 hours period
时间窗: Assesed at 96 hours postoperatively
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
Maximum pain intensity since the last examination
时间窗: Assesed on the 7th postoperative day
Numerical Visual scale questionnaire. a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded Every patient will be examined every 24 hours until complete healling which usualy takes place between 3 and 4 days; after complete healing the next and last examination is performed at the 7th postoperative day
次要结局
- Time required for complete healing(Evaluated each day until complete healing)
- Eye discomfort(Every 24 hours until complete healing and at the 7th day postop)
- Dizziness(Every 24 hours until complete healling and at the 7th day postop)
- Headache(Every 24 hours until complete healing and at the 7th day postop)
- Visual acuity(every day until complete healing and at the 7th day postop)
- Foreign body sensation(Every 24 hours until complete healing and at the 7th day postop)
- Light sensitivity(Every 24 hours until complete healing and at the 7th day postop)
- Tearing and watery eyes(Every 24 hours until complete healing and at the 7th day postop)
- lethargy(Every 24 hours until complete healing and at the 7th day postop)
- Gastro-intestinal symptoms(Every 24 hours until complete healing and at the 7th day postop)
研究者
ALEJANDRO LICHTINGER
MD
Codet Vision Institute