Clinical trial NCT01177514: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain After Photorefractive Keratectomy
Keywords: Refractive surgery
PRK
PAIN
Gabapentin
Lead sponsor: Codet Vision Institute
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Pain at moment of examination
timeFrame: 24 hours postoperatively
measure: Average pain for the previous 24 hour period,
timeFrame: assesed at 24 hours
measure: Maximum pain intensity for the previous 24 hour period
timeFrame: Assesed at 24 hours postoperatively
measure: Pain at moment of examination
timeFrame: 48 hours postoperatively
measure: pain on examination
timeFrame: 72 hours postoperatively
measure: pain on examination
timeFrame: 96 hours ostoiperatively
measure: Pain at moment of examination
timeFrame: postoperative day 7
measure: Average pain for the previous 24 hour period
timeFrame: Assesed at 48 hours
measure: Average pain during the previous 24 hour period
timeFrame: Assesed at 72 hours postoperatively
measure: Average pain for the last 24 hours period
timeFrame: Assesed at 96 hours postoperatively
measure: Average pain since last examination
timeFrame: Assesed on postopertive day 7
measure: Maximum pain intensity for the previous 24 hour period
timeFrame: Assesed at 48 hours postoperatively
measure: Maximum pain intensity for the previous 24 hour period
timeFrame: Assesed at 72 hours postoperatively
measure: Maximum pain intensity for the last 24 hour period
timeFrame: Assesed at 96 hours postoperatively
measure: Maximum pain intensity since the last examination
timeFrame: Assesed on the 7th postoperative day
Secondary outcomes:
measure: Time required for complete healing
timeFrame: Evaluated each day until complete healing
measure: Visual acuity
timeFrame: every day until complete healing and at the 7th day postop
measure: Foreign body sensation
timeFrame: Every 24 hours until complete healing and at the 7th day postop
measure: Light sensitivity
timeFrame: Every 24 hours until complete healing and at the 7th day postop
measure: Tearing and watery eyes
timeFrame: Every 24 hours until complete healing and at the 7th day postop
measure: Eye discomfort
timeFrame: Every 24 hours until complete healing and at the 7th day postop
measure: Dizziness
timeFrame: Every 24 hours until complete healling and at the 7th day postop
measure: lethargy
timeFrame: Every 24 hours until complete healing and at the 7th day postop
measure: Headache
timeFrame: Every 24 hours until complete healing and at the 7th day postop
measure: Gastro-intestinal symptoms
timeFrame: Every 24 hours until complete healing and at the 7th day postop
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Codet Vision Institute
state: Baja California
Study officials:
References: