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NCT Number: NCT06752486

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

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.

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Key information

Conditions

Pain After Photorefractive Keratectomy VAS Will be Used to Assess Pain Postoperative

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Institute of Ophthalmolgy

Giza, Egypt

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Giving post photorefractive keratectomy for pain relief

Drug

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.

Primary outcomes

  1. Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.

    Time frame: 72 hours postoperative

    pain assessment using Visual Analogue Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Moustafa M Ali, MD

CONTACT

[email protected]

01113981021

Mohamed Tarek Ahmed El- Naggar, MD- FRCS

CONTACT

[email protected]

01222158593

Sponsors and collaborators

Lead sponsor

Research Institute of Ophthalmology, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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