Back to resultsThe Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
Primary Purpose
Pain After Photorefractive Keratectomy
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Gabapentin
Sugar pill
Sponsored by
About this trial
This is an interventional supportive care trial for Pain After Photorefractive Keratectomy focused on measuring Refractive surgery, PRK, PAIN, Gabapentin
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Codet Vision Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GABAPENTIN
PLACEBO
Arm Description
Group of patients treated with oral gabapentin
Group given the placebo capsules
Outcomes
Primary Outcome Measures
Pain at moment of examination
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,
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time required for complete healing
Slit lamp observation of the epithelial defect and time until removal of contact lens.
Visual acuity
Snellen Chart
Foreign body sensation
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
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
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
Numerical visual scale questionnaire, In a scale from 0-10 where 0 is the least amount of discomfort and 10 being the most.
Dizziness
Numerical visual scale, scale from 0-10 where 0 is the least dizzy and 10 being the most.
lethargy
Numerical visual scale, In a scale from 0-10 where 0 is the least lethargic and 10 is the most.
Headache
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
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of symptoms and 10 being the most symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01177514
Brief Title
The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
Official Title
The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy A Prospective, Randomized, Double Blinded, Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Codet Vision Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain After Photorefractive Keratectomy
Keywords
Refractive surgery, PRK, PAIN, Gabapentin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GABAPENTIN
Arm Type
Experimental
Arm Description
Group of patients treated with oral gabapentin
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Group given the placebo capsules
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Intervention Description
Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.
Primary Outcome Measure Information:
Title
Pain at moment of examination
Description
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
Time Frame
24 hours postoperatively
Title
Average pain for the previous 24 hour period,
Description
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
Time Frame
assesed at 24 hours
Title
Maximum pain intensity for the previous 24 hour period
Description
In a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded.
Time Frame
Assesed at 24 hours postoperatively
Title
Pain at moment of examination
Description
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
Time Frame
48 hours postoperatively
Title
pain on examination
Description
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
Time Frame
72 hours postoperatively
Title
pain on examination
Description
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
Time Frame
96 hours ostoiperatively
Title
Pain at moment of examination
Description
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
Time Frame
postoperative day 7
Title
Average pain for the previous 24 hour period
Description
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
Time Frame
Assesed at 48 hours
Title
Average pain during the previous 24 hour period
Description
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
Time Frame
Assesed at 72 hours postoperatively
Title
Average pain for the last 24 hours period
Description
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
Time Frame
Assesed at 96 hours postoperatively
Title
Average pain since last examination
Description
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
Time Frame
Assesed on postopertive day 7
Title
Maximum pain intensity for the previous 24 hour period
Description
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
Time Frame
Assesed at 48 hours postoperatively
Title
Maximum pain intensity for the previous 24 hour period
Description
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
Time Frame
Assesed at 72 hours postoperatively
Title
Maximum pain intensity for the last 24 hour period
Description
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
Time Frame
Assesed at 96 hours postoperatively
Title
Maximum pain intensity since the last examination
Description
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
Time Frame
Assesed on the 7th postoperative day
Secondary Outcome Measure Information:
Title
Time required for complete healing
Description
Slit lamp observation of the epithelial defect and time until removal of contact lens.
Time Frame
Evaluated each day until complete healing
Title
Visual acuity
Description
Snellen Chart
Time Frame
every day until complete healing and at the 7th day postop
Title
Foreign body sensation
Description
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of foreign body sensation and 10 being the most.
Time Frame
Every 24 hours until complete healing and at the 7th day postop
Title
Light sensitivity
Description
Numerical visual scale, in a scale from 0-10 where 0 is the least amount of light sensitibity and 10 being the most.
Time Frame
Every 24 hours until complete healing and at the 7th day postop
Title
Tearing and watery eyes
Description
Numerical visual scale questionaire, In a scale from 0-10 where 0 is the least amount of tearing and 10 being the most.
Time Frame
Every 24 hours until complete healing and at the 7th day postop
Title
Eye discomfort
Description
Numerical visual scale questionnaire, In a scale from 0-10 where 0 is the least amount of discomfort and 10 being the most.
Time Frame
Every 24 hours until complete healing and at the 7th day postop
Title
Dizziness
Description
Numerical visual scale, scale from 0-10 where 0 is the least dizzy and 10 being the most.
Time Frame
Every 24 hours until complete healling and at the 7th day postop
Title
lethargy
Description
Numerical visual scale, In a scale from 0-10 where 0 is the least lethargic and 10 is the most.
Time Frame
Every 24 hours until complete healing and at the 7th day postop
Title
Headache
Description
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.
Time Frame
Every 24 hours until complete healing and at the 7th day postop
Title
Gastro-intestinal symptoms
Description
Numerical visual scale, In a scale from 0-10 where 0 is the least amount of symptoms and 10 being the most symptoms.
Time Frame
Every 24 hours until complete healing and at the 7th day postop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Codet Vision Institute
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22320
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
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