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Recruiting NCT07141589

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

No phase Interventional Fentanyl Ketorolac Adjuvant Peribulbar Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lidocaine + Bupivacaine + Hyaluronidase, Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase, Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase.
Who it may be relevant to
Registry conditions: Fentanyl, Ketorolac, Adjuvant, Peribulbar Block. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries, A Prospective Double-blinded Randomized Controlled Study

Overview

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.

Interventions

  • Drug 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.
  • 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.
  • 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.

Primary outcome measures

  • Duration of globe akinesia [Time frame: 10 minutes after injection]
Secondary outcome measures (6)
  • Heart rate [Time frame: Intraoperatively]
  • Blood pressure [Time frame: Intraoperatively]
  • Onset of globe akinesia [Time frame: 10 minutes after injection]
  • Onset of corneal anesthesia [Time frame: 1 minute after injection]
  • Degree of pain [Time frame: 6 hours postoperatively]
  • Time of first rescue analgesia [Time frame: 6 hours postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT07141589 · MD-264-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗