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.
ConditionPain After Photorefractive Keratectomy
InterventionDrug: Gabapentin
Drug: Sugar pill
PhasePhase 4
SponsorCodet Vision Institute
Responsible PartyCodet Vision Institute
ClinicalTrials.gov IdentifierNCT01177514
First ReceivedApril 23, 2010
Last UpdatedAugust 10, 2010
Last verifiedAugust 2010

Tracking Information[ + expand ][ + ]

First Received DateApril 23, 2010
Last Updated DateAugust 10, 2010
Start DateApril 2010
Estimated Primary Completion DateAugust 2010
Current Primary Outcome Measures
  • Pain at moment of examination [Time Frame: 24 hours postoperatively] [Designated as safety issue: No]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, [Time Frame: assesed at 24 hours] [Designated as safety issue: No]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 [Time Frame: Assesed at 24 hours postoperatively] [Designated as safety issue: No]In a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded.
  • Pain at moment of examination [Time Frame: 48 hours postoperatively] [Designated as safety issue: No]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 [Time Frame: 72 hours postoperatively] [Designated as safety issue: No]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 [Time Frame: 96 hours ostoiperatively] [Designated as safety issue: No]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 [Time Frame: postoperative day 7] [Designated as safety issue: No]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 [Time Frame: Assesed at 48 hours] [Designated as safety issue: No]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 [Time Frame: Assesed at 72 hours postoperatively] [Designated as safety issue: No]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 [Time Frame: Assesed at 96 hours postoperatively] [Designated as safety issue: No]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 [Time Frame: Assesed on postopertive day 7] [Designated as safety issue: No]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 previous 24 hour period [Time Frame: Assesed at 48 hours postoperatively] [Designated as safety issue: No]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 previous 24 hour period [Time Frame: Assesed at 72 hours postoperatively] [Designated as safety issue: No]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 [Time Frame: Assesed at 96 hours postoperatively] [Designated as safety issue: No]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 [Time Frame: Assesed on the 7th postoperative day] [Designated as safety issue: No]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
Current Secondary Outcome Measures
  • Time required for complete healing [Time Frame: Evaluated each day until complete healing] [Designated as safety issue: No]Slit lamp observation of the epithelial defect and time until removal of contact lens.
  • Visual acuity [Time Frame: every day until complete healing and at the 7th day postop] [Designated as safety issue: No]Snellen Chart
  • Foreign body sensation [Time Frame: Every 24 hours until complete healing and at the 7th day postop] [Designated as safety issue: No]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 [Time Frame: Every 24 hours until complete healing and at the 7th day postop] [Designated as safety issue: No]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 [Time Frame: Every 24 hours until complete healing and at the 7th day postop] [Designated as safety issue: No]Numerical visual scale questionaire, In a scale from 0-10 where 0 is the least amount of tearing and 10 being the most.
  • Eye discomfort [Time Frame: Every 24 hours until complete healing and at the 7th day postop] [Designated as safety issue: No]Numerical visual scale questionnaire, In a scale from 0-10 where 0 is the least amount of discomfort and 10 being the most.
  • Dizziness [Time Frame: Every 24 hours until complete healling and at the 7th day postop] [Designated as safety issue: Yes]Numerical visual scale, scale from 0-10 where 0 is the least dizzy and 10 being the most.
  • lethargy [Time Frame: Every 24 hours until complete healing and at the 7th day postop] [Designated as safety issue: Yes]Numerical visual scale, In a scale from 0-10 where 0 is the least lethargic and 10 is the most.
  • Headache [Time Frame: Every 24 hours until complete healing and at the 7th day postop] [Designated as safety issue: Yes]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.
  • Gastro-intestinal symptoms [Time Frame: Every 24 hours until complete healing and at the 7th day postop] [Designated as safety issue: Yes]Numerical visual scale, In a scale from 0-10 where 0 is the least amount of symptoms and 10 being the most symptoms.

Descriptive Information[ + expand ][ + ]

Brief TitleThe Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
Official TitleThe 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
ConditionPain After Photorefractive Keratectomy
InterventionDrug: 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)
  • Experimental: GABAPENTIN
    Group of patients treated with oral gabapentin
  • Placebo Comparator: PLACEBO
    Group given the placebo capsules

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment40
Estimated Completion DateAugust 2010
Estimated Primary Completion DateJuly 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesMexico

Administrative Information[ + expand ][ + ]

NCT Number NCT01177514
Other Study ID NumbersGABA1
Has Data Monitoring CommitteeYes
Information Provided ByCodet Vision Institute
Study SponsorCodet Vision Institute
CollaboratorsNot Provided
Investigators Not Provided
Verification DateAugust 2010

Locations[ + expand ][ + ]

Codet Vision Institute
Tijuana, Baja California, Mexico, 22320