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

NCT ID: NCT06752486

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-06-30

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.

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gabapentin Group

The first group will be given gabapentin orally in a dose of 300mg three times daily post photorefractive keratectomy for 72 hours

Group Type: ACTIVE_COMPARATOR

Giving post photorefractive keratectomy for pain relief

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Giving post photorefractive keratectomy for pain relief

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Institute of Ophthalmology, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Dina Moustafa Mohamed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Research Institute of Ophthalmolgy

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina Moustafa M Ali, MD

Role: CONTACT

dina.moustafa.ali@gmail.com

01113981021

Mohamed Tarek Ahmed El- Naggar, MD- FRCS

Role: CONTACT

drtarekelnaggar@hotmail.com

01222158593

Other Identifiers

25-2-23-3-6

Identifier Type: -

Identifier Source: org_study_id