A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery

October 3, 2020 updated by: Julie Meek, 59th Medical Wing

A Comparison of Pregabalin (Lyrica®) to Placebo in Postoperative Pain Relief of Patients Status-post Photorefractive Keratectomy: A Double-masked Randomized Prospective Study

The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study subjects will be taken from a standard group of typical candidates for PRK surgery including active duty and DoD (Department of Defense) beneficiaries. Prior to being approached for the study, all patients will have had a previous desire for surgery and had a pre-operative evaluation indicating healthy ocular status.

Patients scheduled for PRK surgery will be briefed on the purpose of the study and invited to participate at the preoperative appointment. After the consent process, patients will be randomized in a 1:1 fashion to receive either oral pregabalin 75mg twice daily or placebo for pain control, in addition to the standard care treatment of as needed Percocet and tetracaine ophthalmic drops. Subjects will be evaluated daily for 4 days post-operatively for subjective pain assessment, adverse drug events and compliance, use of concomitant medications as well as monitoring of healing time. Quality of life will be measured at baseline and post-op day 2 when the peak of pain is anticipated. Analysis will be performed to detect an approximate 10% improvement in pain scores. Secondary outcomes will include measuring healing time, quality of life and use of rescue medications.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lackland Air Force Base, Texas, United States, 78236
        • Wilford Hall Medical Center - Refractive Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy ocular status
  • Stable preoperative refractive anisometropia
  • Consented to the PRK surgical procedure

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Diagnosed with autoimmune disease or diabetes
  • Patients with a known adverse reaction or hypersensitivity to gabapentin or pregabalin
  • Patients only desiring PRK on one eye
  • Patients with history of drug use/abuse/addiction
  • Patients who are on chronic pain medications
  • Patients currently taking anti-epileptic, antidepressant and/or anti-psychotic medications
  • Patients with a history of suicidality
  • Patients with chronic renal insufficiency (defined as estimated creatinine clearance less than 30ml/min or Scr ≥ 2.0) 10) Patients who have experienced angioedema, or have heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pregabalin
Oral Pregabalin 75 mg capsule twice daily administered prior to PRK and continued for 5 days
Drug: pregabalin
1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.
Other Names:
  • Lyrica
Placebo Comparator: Placebo
Oral placebo capsule (Lactose) twice daily administered prior to PRK and continued for 5 days
Drug: Placebo
1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Efficacy
Time Frame: 5 days
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Primary efficacy is assessed on 100mm Visual Analog Scale (VAS); total range is 0 to 100. A score closer to zero indicates a better outcome of less pain.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPI Score
Time Frame: 5 days
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed with present pain intensity (PPI) score. Scale is 0 (no pain) to 5 (excruciating pain)
5 days
Total MPQ Score
Time Frame: 5 days
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed using the Total MPQ Score. Scale minimum is 0 (no pain) to maximum of 45 (severe pain). A higher score indicates a worse outcome.
5 days
Quality of Life - BPI
Time Frame: 5 days
Determine if there was an improvement in the patient's functional health and well-being associated with pregabalin compared to standard of care as assessed by Brief Pain Inventory-short form (BPI-SF). Data was assessed on the day of surgery (Day 0) and at the expected peak of pain, postop Day 2 in the morning. Scale is minimum 0 (no pain) to maximum of 10 (pain as bad as you can imagine). A higher score indicates a worse outcome.
5 days
Clinical Efficacy 2
Time Frame: 5 days
Determine if there was a reduction in the need for use of rescue pain medications, Percocet and tetracaine, in those subjects who received pregabalin. Total number of doses was collected. A higher number of doses required indicates a worse outcome.
5 days
Epithelial Healing Time
Time Frame: 5 days or more
Determine if there was a reduction in healing time associated with pregabalin as seen with daily slit-lamp observation. Epithelial defect was measured at post-operative day 3, 5, 7, and 9 in each eye. A higher number of days required for healing indicates a worse outcome.
5 days or more

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

59th Medical Wing

Investigators

  • Principal Investigator: Julie M Meek, PharmD, 59th Medical Wing
  • Study Chair: Charles Reilly, MD, 59th Medical Wing
  • Study Director: Margaret Bonnie Rosbolt, PharmD, CCRC, 59th Medical Wing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

March 31, 2010

First Posted (Estimate)

April 1, 2010

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 3, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20100004H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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