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The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Codet Vision Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Codet Vision Institute
ClinicalTrials.gov Identifier:
NCT01177514
First received: April 23, 2010
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  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.


Condition Intervention Phase
Pain After Photorefractive Keratectomy
 Drug: Gabapentin
Drug: Sugar pill
 Phase 4

Study Type: Interventional
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
Official Title: The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy A Prospective, Randomized, Double Blinded, Placebo Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Codet Vision Institute:

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



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.


Estimated Enrollment: 40
Study Start Date: April 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GABAPENTIN
Group of patients treated with oral gabapentin
 Drug: Gabapentin
Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.
Placebo Comparator: PLACEBO
Group given the placebo capsules
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177514

Locations
Mexico
Codet Vision Institute
Tijuana, Baja California, Mexico, 22320
Sponsors and Collaborators
Codet Vision Institute
  More Information

No publications provided

Responsible Party: Arturo Chayet MD, Codet Vision Institute
ClinicalTrials.gov Identifier: NCT01177514     History of Changes
Other Study ID Numbers: GABA1
Study First Received: April 23, 2010
Last Updated: August 10, 2010
Health Authority: Mexico: Ministry of Health

Keywords provided by Codet Vision Institute:
Refractive surgery
PRK
PAIN
Gabapentin

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
 Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 22, 2013