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

This study has been completed.
Sponsor:
Information provided by:
Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT01097577
First received: March 31, 2010
Last updated: June 21, 2010
Last verified: June 2010
  Purpose

Purpose: To compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.

Patients: Study subjects will be taken from a standard group of typical candidates for PRK surgery including active duty and DoD 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.

Methods: 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 BID 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.


Condition Intervention
Postoperative Pain
Drug: pregabalin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Pregabalin (Lyrica®) to Placebo in Postoperative Pain Relief of Patients Status-post Photorefractive Keratectomy: A Double-masked Randomized Prospective Study

Resource links provided by NLM:


Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • Clinical Efficacy [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Clinical efficacy 2 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Determine if there was a reduction in the need for use of rescue pain medications, Percocet and tetracaine, in those subjects who received pregabalin.

  • Epithelial healing time [ Time Frame: 5 days or more ] [ Designated as safety issue: Yes ]
    Determine if there was a reduction in healing time associated with pregabalin as seen with daily slit-lamp observation.

  • Quality of Life [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 150
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pregabalin Drug: pregabalin
1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
Other Name: Lyrica
Placebo Comparator: lactose capsule Drug: Placebo
1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01097577

Locations
United States, Texas
Wilford Hall Medical Center - Refractive Surgery Center
Lackland AFB, Texas, United States, 78236
Sponsors and Collaborators
Wilford Hall Medical Center
Investigators
Principal Investigator: Julie M Meek, PharmD Wilford Hall Medical Center
Study Chair: Charles Reilly, MD Wilford Hall Medical Center
Study Director: Margaret Bonnie Rosbolt, PharmD, CCRC Wilford Hall Medical Center
  More Information

Publications:

Responsible Party: Capt Julie Meek, Wilford Hall Medical Center, US Air Force
ClinicalTrials.gov Identifier: NCT01097577     History of Changes
Other Study ID Numbers: FWH20100004H
Study First Received: March 31, 2010
Last Updated: June 21, 2010
Health Authority: United States: Federal Government

Keywords provided by Wilford Hall Medical Center:
photorefractive keratectomy
excimer laser
PRK
pain, postoperative
pregabalin

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014