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

March 31, 2010
June 21, 2010
March 2010
June 2010   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01097577 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery
A Comparison of Pregabalin (Lyrica®) to Placebo in Postoperative Pain Relief of Patients Status-post Photorefractive Keratectomy: A Double-masked Randomized Prospective Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: pregabalin
    1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
    Other Name: Lyrica
  • Drug: Placebo
    1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
  • Experimental: pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: lactose capsule
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01097577
FWH20100004H
Yes
Capt Julie Meek, Wilford Hall Medical Center, US Air Force
Wilford Hall Medical Center
Not Provided
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
Wilford Hall Medical Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP