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

Cairo University (CU)

Status: Enrolling

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

Treatments: Drug: Lidocaine + Bupivacaine + Hyaluronidase; Drug: Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase; Drug: Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase

Study type: Interventional

Funder types: Other

Identifiers

NCT07141589

MD-264-2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 3 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine + Bupivacaine + Hyaluronidase

Fentanyl group

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase

Ketorolac group

Experimental group

Description:

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.

Treatment:

Drug: Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase