Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Loma Linda University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00954187
First received: August 5, 2009
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in postoperative pain control after photorefractive keratectomy (PRK).

Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one or both eyes will be randomized into one of two treatment groups. Those in group A will be treated with gabapentin, and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery in order to achieve therapeutic blood levels of each medication. After surgery the patients will assess their pain level using the visual analogue scale (VAS) at different intervals of time - one hour after surgery, the evening of the surgery, and three times each day for three subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same amount of time. On the fourth day they will return to clinic for a postoperative appointment. At that time the pain, sleepiness, and dizziness assessment scales will be collected and analyzed. The patients will return one month later to further assess long-term pain and healing after PRK.

Results: Both gabapentin and pregabalin have been shown in previous studies to treat postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will be presented.

Conclusion: The effectiveness of the two different treatment medications will be analyzed, and the conclusion will be based on the results.


Condition Intervention
Postoperative Pain
Drug: Gabapentin
Drug: pregabalin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy: a Prospective, Randomized Study.

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Decreased overall pain score as measured by the visual analogue scale [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin
Neurontin
Drug: Gabapentin
Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days
Other Name: Neurontin
Experimental: Pregabalin
Lyrica
Drug: pregabalin
50 mg PO TID
Other Name: Lyrica

Detailed Description:

METHODS:

One hundred and four patients who meet the inclusion criteria undergoing photorefractive keratectomy (PRK) in one or both eyes will be randomly assigned into one of two treatment groups via computer. Those in group A will be treated with gabapentin and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery. Patients in the gabapentin group will take 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days. Patients in the pregabalin group will take 50 mg three times a day starting two hours prior to surgery and will also continue for four days.

Only the refractive surgery coordinator and the patient will know what medication the patient is taking. The patient will be instructed not to share this information with any other study participants or their surgeon. The coordinator will keep a list of the patients ID numbers and the treatments they are receiving.

Prior to surgery, each patient will be taught how to assess their pain level using the visual analogue scale (VAS), a well documented method of pain assessment. After surgery the patients will assess their pain levels at different intervals of time - one hour after surgery, the evening of the surgery, and three times a day for four subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness daily for the same amount of time. On the fourth day they will return to clinic for a post operative appointment. At that time the pain assessment scales will be collected and analyzed. The patients will return at one month to further assess long term pain after PRK.

Statistical Analysis:

Postoperative pain levels recorded using the visual analogue scales, ESS, and self reported dizziness assessments will be collected on the fourth postoperative day. These will be compiled into data sets and analyzed. Data will be compiled into means with lower and upper quartiles and analyzed using a two-sided t test. The difference in pain levels will be described throughout the postoperative period to determine if one medication significantly reduces postoperative pain initially within the first 24 hours, during the interval between 24 hours to four days, and further after surgery (one month postoperatively). Data regarding levels of somnolence and dizziness will also be reported.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Undergoing PRK in at least one eye

Exclusion Criteria:

  • Serious medical problems within the last 6 months including myocardial infarction (heart attack), congestive heart failure, stroke, deep vein thrombosis, pulmonary embolism, and other conditions, etc.
  • Serious kidney disease as evidenced by the need for dialysis or kidney transplant.
  • History of seizure or other neurologic disorders.
  • Patients intending to become pregnant or who are pregnant or nursing over the projected course of treatment.
  • Currently taking gabapentin or pregabalin for other medical purposes.
  • Known allergic reaction to gabapentin or pregabalin from previous use.
  • Plans to move out of the area within 8 weeks after the surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954187

Contacts
Contact: Julio Narvaez, MD 909-558-2169 narvaezjd@verizon.net
Contact: Alyssa Hoehn, BS 909-558-2169 abowen@llu.edu

Locations
United States, California
Loma Linda University - Ophthalmology Recruiting
Loma Linda, California, United States, 92354
Contact: Blen Eshete, MPH(c)    909-558-2076    beshete@llu.edu   
Principal Investigator: Julio Narvaez, MD         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Julio Narvaez, MD Loma Linda University
  More Information

Publications:

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00954187     History of Changes
Other Study ID Numbers: 59070
Study First Received: August 5, 2009
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antiparkinson Agents
Anti-Dyskinesia 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 September 18, 2014