Clinical trial NCT01097577: A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: photorefractive keratectomy
excimer laser
PRK
pain, postoperative
pregabalin
Lead sponsor: 59th Medical Wing
Sponsor class: FED
First posted: 2010-04-01
Enrollment: 130
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Clinical Efficacy
timeFrame: 5 days
Secondary outcomes:
measure: PPI Score
timeFrame: 5 days
measure: Total MPQ Score
timeFrame: 5 days
measure: Quality of Life - BPI
timeFrame: 5 days
measure: Clinical Efficacy 2
timeFrame: 5 days
measure: Epithelial Healing Time
timeFrame: 5 days or more
Other outcomes:
Locations:
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center - Refractive Surgery Center
state: Texas
Study officials:
affiliation: 59th Medical Wing
name: Julie M Meek, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: 59th Medical Wing
name: Charles Reilly, MD
role: STUDY_CHAIR
affiliation: 59th Medical Wing
name: Margaret Bonnie Rosbolt, PharmD, CCRC
role: STUDY_DIRECTOR
References:
citation: Meek JM, Rosbolt MB, Taylor KR, Fusco EA, Panday VA, Reilly CD. Pregabalin versus placebo in postoperative pain relief of patients' status post photorefractive keratectomy: a double-masked, randomized, prospective study. J Ocul Pharmacol Ther. 2014 Sep;30(7):527-32. doi: 10.1089/jop.2013.0208. Epub 2014 Jun 10.