The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
- Conditions
- Pain After Photorefractive Keratectomy
- Interventions
- Drug: Sugar pill
- Registration Number
- NCT01177514
- Lead Sponsor
- Codet Vision Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PLACEBO Sugar pill Group given the placebo capsules GABAPENTIN Gabapentin Group of patients treated with oral gabapentin
- Primary Outcome Measures
Name Time Method Average pain for the previous 24 hour period, 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 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 dayPain at moment of examination 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 dayAverage pain since last examination 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 dayMaximum pain intensity for the last 24 hour period 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 daypain on examination 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 dayAverage pain for the previous 24 hour period 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 dayAverage pain during the previous 24 hour period 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 dayAverage pain for the last 24 hours period 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 dayMaximum pain intensity since the last examination 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
- Secondary Outcome Measures
Name Time Method Time required for complete healing Evaluated each day until complete healing Slit lamp observation of the epithelial defect and time until removal of contact lens.
Eye discomfort Every 24 hours until complete healing and at the 7th day postop Numerical visual scale questionnaire, In a scale from 0-10 where 0 is the least amount of discomfort and 10 being the most.
Dizziness Every 24 hours until complete healling and at the 7th day postop Numerical visual scale, scale from 0-10 where 0 is the least dizzy and 10 being the most.
Headache Every 24 hours until complete healing and at the 7th day postop Numerical visual scale, In a scale from 0-10 where 0 is the least amount of headache and 10 being the most severe headache felt.
Visual acuity every day until complete healing and at the 7th day postop Snellen Chart
Foreign body sensation Every 24 hours until complete healing and at the 7th day postop Numerical visual scale, In a scale from 0-10 where 0 is the least amount of foreign body sensation and 10 being the most.
Light sensitivity Every 24 hours until complete healing and at the 7th day postop Numerical visual scale, in a scale from 0-10 where 0 is the least amount of light sensitibity and 10 being the most.
Tearing and watery eyes Every 24 hours until complete healing and at the 7th day postop Numerical visual scale questionaire, In a scale from 0-10 where 0 is the least amount of tearing and 10 being the most.
lethargy Every 24 hours until complete healing and at the 7th day postop Numerical visual scale, In a scale from 0-10 where 0 is the least lethargic and 10 is the most.
Gastro-intestinal symptoms Every 24 hours until complete healing and at the 7th day postop Numerical visual scale, In a scale from 0-10 where 0 is the least amount of symptoms and 10 being the most symptoms.
Trial Locations
- Locations (1)
Codet Vision Institute
🇲🇽Tijuana, Baja California, Mexico