Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries

NCT07141589 | Recruiting

• 1 other identifier: MD-264-2024
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy of ketorolac and fentanyl as adjuvants to local anesthetics for anterior segment surgeries of the eye.

Conditions

Fentanyl; Ketorolac; Adjuvant; Peribulbar Block; Anterior Segment Surgeries

Outcome Measures

Primary Outcomes (1)

• Duration of globe akinesia

  Assessment of Globe akinesia will be assessed at 2, 5 and 10 minutes after injection with a 12-point scale. Each of the four rectus muscles and each lid score from 0 to 2; 0 = total akinesia, 1 = partial akinesia, 2 = no akinesia)

  10 minutes after injection

Secondary Outcomes (6)

• Heart rate

  Intraoperatively

• Blood pressure

  Intraoperatively

• Onset of globe akinesia

  10 minutes after injection

• Onset of corneal anesthesia

  1 minute after injection

• Degree of pain

  6 hours postoperatively

Study Arms (3)

Control group

ACTIVE COMPARATOR

Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, hyaluronidase 60 IU diluted in normal saline to a total volume of 8 ml.

Drug: Lidocaine + Bupivacaine + Hyaluronidase

Fentanyl group

EXPERIMENTAL

Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, and hyaluronidase 60 IU and fentanyl 20 μg diluted in normal saline to a total volume of 8 ml.

Drug: Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase

Ketorolac group

EXPERIMENTAL

Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, hyaluronidase 60 IU, and ketorolac 15 mg diluted in normal saline to a total volume of 8 ml.

Drug: Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase

Interventions

Lidocaine + Bupivacaine + Hyaluronidase DRUG

Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, and hyaluronidase 60 IU diluted in normal saline to a total volume of 8 ml.

Control group

Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase DRUG

Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, and hyaluronidase 60 IU and fentanyl 20 μg diluted in normal saline to a total volume of 8 ml.

Fentanyl group

Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase DRUG

Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, hyaluronidase 60 IU, and ketorolac 15 mg diluted in normal saline to a total volume of 8 ml.

Ketorolac group

Eligibility Criteria

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

You may qualify if:

• Age over 18 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Scheduled to undergo operations for anterior segment surgeries of the eye under local (peribulbar) anesthesia.

You may not qualify if:

• Patient's refusal.
• Known allergy or hypersensitivity to aspirin or nonsteroidal anti-inflammatory medications.
• Patients with contraindications to local anesthetics, such as high axial length or patients with high preoperative intraocular pressure.
• If cases develop severe pain intraoperatively from the start, necessitating rescue analgesia and sedation or requiring conversion to general anesthesia.
• Infection at the site of injection.
• Patients with coagulopathies or on anticoagulants.
• Impaired renal function.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine; Bupivacaine; Hyaluronoglucosaminidase; Fentanyl; Ketorolac

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Aya M Abo Zied, Master

CONTACT

00201126720605; Ayamezoo111@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: August 25, 2024
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)