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

NCT01177514 | Completed Phase 4 DMC

• 1 other identifier: GABA1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain After Photorefractive Keratectomy

Keywords

Refractive surgery; PRK; PAIN; Gabapentin

Outcome Measures

Primary Outcomes (15)

• 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

  24 hours postoperatively

• 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

  assesed at 24 hours

• 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.

  Assesed at 24 hours postoperatively

• 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

  48 hours postoperatively

• 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

  72 hours postoperatively

• 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

  96 hours ostoiperatively

• 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

  postoperative day 7

• 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

  Assesed at 48 hours

• 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

  Assesed at 72 hours postoperatively

• 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

  Assesed at 96 hours postoperatively

• 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

  Assesed on postopertive day 7

• 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

  Assesed at 48 hours postoperatively

• 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

  Assesed at 72 hours postoperatively

• 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

  Assesed at 96 hours postoperatively

• 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

  Assesed on the 7th postoperative day

Secondary Outcomes (10)

• Time required for complete healing

  Evaluated each day until complete healing

• Visual acuity

  every day until complete healing and at the 7th day postop

• Foreign body sensation

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

• Light sensitivity

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

• Tearing and watery eyes

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

Study Arms (2)

GABAPENTIN

EXPERIMENTAL

Group of patients treated with oral gabapentin

Drug: Gabapentin

PLACEBO

PLACEBO COMPARATOR

Group given the placebo capsules

Drug: Sugar pill

Interventions

Gabapentin DRUG

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

GABAPENTIN

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.

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Codet Vision Institute: lead

Study Sites (1)

Codet Vision Institute

Tijuana, Estado de Baja California, 22320, Mexico

Location

MeSH Terms

Conditions

Pain

Interventions

Gabapentin; Sugars

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: August 9, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

ME (1)