The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Pain After Photorefractive Keratectomy |
Intervention | Drug: Gabapentin Drug: Sugar pill |
Phase | Phase 4 |
Sponsor | Codet Vision Institute |
Responsible Party | Codet Vision Institute |
ClinicalTrials.gov Identifier | NCT01177514 |
First Received | April 23, 2010 |
Last Updated | August 10, 2010 |
Last verified | August 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | April 23, 2010 |
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Last Updated Date | August 10, 2010 |
Start Date | April 2010 |
Estimated Primary Completion Date | August 2010 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy |
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Official Title | The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy A Prospective, Randomized, Double Blinded, Placebo Controlled Study |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care |
Condition | Pain After Photorefractive Keratectomy |
Intervention | Drug: Gabapentin Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days. Drug: Sugar pill Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 40 |
Estimated Completion Date | August 2010 |
Estimated Primary Completion Date | July 2010 |
Eligibility Criteria | Inclusion Criteria: 1. Subjects must be at least 18 years of age 2. Subjects must not have any corneal disease or degeneration 3. Subjects must be candidates for LASIK or PRK refractive surgery Exclusion Criteria: 1. History of topical ocular medications within 4 weeks prior to enrollment 2. History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment 3. History of a previous refractive surgery 4. History of previous diagnosis of corneal disease, degeneration, or glaucoma 5. History of autoimmune disease 6. History of oral anti-histamines currently or within 1 week of study enrollment 7. History of systemic anti-inflammatory or pain medication currently or within 4 weeks of study enrollment 8. Use of oral diuretics or betablocker currently or within 1 week of study enrollment 9. Current diagnosis of dry eye 10. Patients whose Best corrected vision is less than 20/20 11. Patients whose target post operative refraction is not plano 12. Pregnant and lactating |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Mexico |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01177514 |
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Other Study ID Numbers | GABA1 |
Has Data Monitoring Committee | Yes |
Information Provided By | Codet Vision Institute |
Study Sponsor | Codet Vision Institute |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | August 2010 |
Locations[ + expand ][ + ]
Codet Vision Institute | Tijuana, Baja California, Mexico, 22320 |
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