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

NCT06752486 | Recruiting Phase 1

• 1 other identifier: 25-2-23-3-6
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gabapentin Group

ACTIVE COMPARATOR

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

Diclofenac potassium Group

ACTIVE COMPARATOR

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: 1. History taking including sociodemographics, medical illnesses, and prior surgery or anesthetic experiences. 2. 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

Interventions

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.

Diclofenac potassium Group; Gabapentin Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Institute of Ophthalmology, Egypt: lead

Study Sites (1)

Research Institute of Ophthalmolgy

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Analgesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Dina Moustafa M Ali, MD

CONTACT

01113981021; dina.moustafa.ali@gmail.com

Mohamed Tarek Ahmed El- Naggar, MD- FRCS

CONTACT

01222158593; drtarekelnaggar@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 30, 2024
• Study Start: December 1, 2024
• Primary Completion: May 10, 2025
• Study Completion: June 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

EG (1)