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

59th Medical Wing

Status

Completed

Conditions

Postoperative Pain

Treatments

Drug: Placebo

Drug: pregabalin

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01097577

FWH20100004H

Details and patient eligibility

About

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

Full 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.

Enrollment

130 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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