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Completed

NCT Number: NCT01177514

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

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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Key information

Conditions

Pain After Photorefractive Keratectomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Codet Vision Institute

Tijuana, Estado de Baja California, 22320, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.

Sugar pill

Drug

Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.

Primary outcomes

  1. Pain at moment of examination

    Time frame: 24 hours postoperatively

    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

  2. Average pain for the previous 24 hour period,

    Time frame: assesed at 24 hours

    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

  3. Maximum pain intensity for the previous 24 hour period

    Time frame: Assesed at 24 hours postoperatively

    In a scale from 0-10 where 0 is the least amount of pain and 10 being the most pain felt was recorded.

  4. Pain at moment of examination

    Time frame: 48 hours postoperatively

    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

  5. pain on examination

    Time frame: 72 hours postoperatively

    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

  6. pain on examination

    Time frame: 96 hours ostoiperatively

    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

  7. Pain at moment of examination

    Time frame: postoperative day 7

    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

  8. Average pain for the previous 24 hour period

    Time frame: Assesed at 48 hours

    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

  9. Average pain during the previous 24 hour period

    Time frame: Assesed at 72 hours postoperatively

    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

  10. Average pain for the last 24 hours period

    Time frame: Assesed at 96 hours postoperatively

    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

  11. Average pain since last examination

    Time frame: Assesed on postopertive day 7

    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

  12. Maximum pain intensity for the previous 24 hour period

    Time frame: Assesed at 48 hours postoperatively

    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

  13. Maximum pain intensity for the previous 24 hour period

    Time frame: Assesed at 72 hours postoperatively

    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

  14. Maximum pain intensity for the last 24 hour period

    Time frame: Assesed at 96 hours postoperatively

    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

  15. Maximum pain intensity since the last examination

    Time frame: Assesed on the 7th postoperative day

    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 outcomes

  1. Time required for complete healing

    Time frame: Evaluated each day until complete healing

    Slit lamp observation of the epithelial defect and time until removal of contact lens.

  2. Visual acuity

    Time frame: every day until complete healing and at the 7th day postop

    Snellen Chart

  3. Foreign body sensation

    Time frame: Every 24 hours until complete healing and at the 7th day postop

    Numerical visual scale, In a scale from 0-10 where 0 is the least amount of foreign body sensation and 10 being the most.

  4. Light sensitivity

    Time frame: Every 24 hours until complete healing and at the 7th day postop

    Numerical visual scale, in a scale from 0-10 where 0 is the least amount of light sensitibity and 10 being the most.

  5. Tearing and watery eyes

    Time frame: Every 24 hours until complete healing and at the 7th day postop

    Numerical visual scale questionaire, In a scale from 0-10 where 0 is the least amount of tearing and 10 being the most.

  6. Eye discomfort

    Time frame: Every 24 hours until complete healing and at the 7th day postop

    Numerical visual scale questionnaire, In a scale from 0-10 where 0 is the least amount of discomfort and 10 being the most.

  7. Dizziness

    Time frame: Every 24 hours until complete healling and at the 7th day postop

    Numerical visual scale, scale from 0-10 where 0 is the least dizzy and 10 being the most.

  8. lethargy

    Time frame: Every 24 hours until complete healing and at the 7th day postop

    Numerical visual scale, In a scale from 0-10 where 0 is the least lethargic and 10 is the most.

  9. Headache

    Time frame: Every 24 hours until complete healing and at the 7th day postop

    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.

  10. Gastro-intestinal symptoms

    Time frame: Every 24 hours until complete healing and at the 7th day postop

    Numerical visual scale, In a scale from 0-10 where 0 is the least amount of symptoms and 10 being the most symptoms.

Sponsors and collaborators

Lead sponsor

Codet Vision Institute

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 9, 2010
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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