Assessment of Safety and Efficacy of Gabapentin After Surface Ablation, a Case Control Experimental Study

Assessment of Safety and Efficacy of Gabapentin for Postoperative Analgesia After Surface Ablation, Versus Diclofenac Potassium as a Gold Standard

The current study aims at assessing the efficacy and safety of oral Gabapentin alone versus Diclofenac Potassium drugs for postoperative analgesia in patients undergoing surface ablation.

Study Overview

• Status: Recruiting
• Conditions: Pain After Photorefractive Keratectomy; VAS Will be Used to Assess Pain Postoperative
• Intervention / Treatment: Drug: Giving post photorefractive keratectomy for pain relief

Detailed Description

To estimate the analgesic effect and pain severity after surface ablation with oral Gabapentin intake in comparison with Diclofenac Potassium, where Gabapentin could be a better analgesic medication after surface ablation

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dina Moustafa M Ali, MD; Phone Number: 01113981021; Email: dina.moustafa.ali@gmail.com
• Study Contact Backup: Name: Mohamed Tarek Ahmed El- Naggar, MD- FRCS; Phone Number: 01222158593; Email: drtarekelnaggar@hotmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Research Institute of Ophthalmolgy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients over 18 years old
• preoperative stable refraction for at least one-year,
• normal corneal tomography with expected postoperative flat K reading not less than 38D, and postoperative residual stromal bed not less than 350 μm.

Exclusion Criteria:

• Patients with preoperative corrected distance visual acuity (CDVA) of worse than 20/30
• amblyopic patients,
• patients with a history of previous ocular surgeries,
• herpetic eye infection, or corneal dystrophies.
• Patients with other ocular conditions e.g. uveal or retinal diseases, and glaucoma
• Diabetics,
• Hypertensives,
• Kidney problems,
• breathing problems
• Adults older than 65 years.
• Previous allergy or adverse reaction to the used drugs.
• History of drug abuse or alcohol abuse problems
• History of mood problems, depression suicidal thoughts or behavior

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gabapentin Group; The first group will be given gabapentin orally in a dose of 300mg three times daily post photorefractive keratectomy for 72 hours	Drug: Giving post photorefractive keratectomy for pain relief; We plan to conduct a randomized prospective study to assess the efficacy and safety of oral Gabapentin versus oral Diclofenac Potassium for postoperative analgesia in adults undergoing surface ablation. The first group will be given gabapentin orally in a dose of 300mg Tid for 72 hours and the second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative.
Active Comparator: Diclofenac potassium Group; the second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative. All patients will be subjected to: History taking including sociodemographics, medical illnesses, and prior surgery or anesthetic experiences.; Examination including assessment of vital data (heart rate, blood pressure, respiratory rate, level of consciousness, and respiratory examination.	Drug: Giving post photorefractive keratectomy for pain relief; We plan to conduct a randomized prospective study to assess the efficacy and safety of oral Gabapentin versus oral Diclofenac Potassium for postoperative analgesia in adults undergoing surface ablation. The first group will be given gabapentin orally in a dose of 300mg Tid for 72 hours and the second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.	pain assessment using Visual Analogue Scale	72 hours postoperative

Collaborators and Investigators

• Sponsor: Research Institute of Ophthalmology, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): May 10, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: 25-2-23-3-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: patient privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No