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

NCT ID: NCT07141589

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-25
• Study Completion Date: 2025-11-25

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.

Detailed Description

Regional anesthesia for eye surgery includes peribulbar, retrobulbar, and sub-Tenon's blocks. Peribulbar block is commonly used due to a lesser incidence of serious complications such as globe perforation and retrobulbar hemorrhage.

Fentanyl is a synthetic opioid widely used as an adjuvant to local anesthetics to prolong its action and provide better postoperative analgesia. fentanyl fastens lid and globe akinesia and provides a better akinesia score.

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that reduces the release of inflammatory mediators such as prostaglandins, thereby reducing afferent sensitivities and finally reducing pain. It is devoid of narcotic analgesic adverse effects such as sedation, nausea, and respiratory depression.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine + Bupivacaine + Hyaluronidase

Intervention Type: 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.

Fentanyl group

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.

Group Type: EXPERIMENTAL

Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase

Intervention Type: 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.

Ketorolac group

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.

Group Type: EXPERIMENTAL

Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase

Intervention Type: 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.

Interventions

Lidocaine + Bupivacaine + Hyaluronidase

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.

Intervention Type: DRUG

Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase

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.

Intervention Type: DRUG

Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Mohamed Abo Zied

Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Aya M Abo Zied, Master

Role: CONTACT

Ayamezoo111@gmail.com

00201126720605

Facility Contacts

Aya M Abo Zied, Master

Role: primary

Ayamezoo111@gmail.com

00201126720605

Other Identifiers

MD-264-2024

Identifier Type: -

Identifier Source: org_study_id