A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery
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.
|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|
- 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).
- 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).
|Study Start Date:||March 2010|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
Other Name: Lyrica
|Placebo Comparator: lactose capsule||
1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097577
|United States, Texas|
|Wilford Hall Medical Center - Refractive Surgery Center|
|Lackland AFB, Texas, United States, 78236|
|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|