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NCT Number: NCT07141589

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Aya M Abo Zied, Master

CONTACT

[email protected]

00201126720605

Ghada A Sherif, MD

SUB_INVESTIGATOR

Mohammad Y Mostafa, MD

SUB_INVESTIGATOR

Tamer F Saafan, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Duration of globe akinesia

    Time frame: 10 minutes after injection

    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)

Secondary outcomes

  1. Heart rate

    Time frame: Intraoperatively

    Intraoperative heart rate will be recorded every 5 minutes in beats per minute.

  2. Blood pressure

    Time frame: Intraoperatively

    Intraoperative blood pressure will be recorded every 5 minutes in mmHg.

  3. Onset of globe akinesia

    Time frame: 10 minutes after injection

    The onset of lid akinesia will be the elapsed time between the peribulbar injection and partial loss of lid movement.

  4. Onset of corneal anesthesia

    Time frame: 1 minute after injection

    The onset of anesthesia will be defined as the time interval between performing the block and loss of corneal sensation.

  5. Degree of pain

    Time frame: 6 hours postoperatively

    Pain will be assessed immediately after the operation , then after 1 h, 2 h, 4 h and 6 h by verbal rating scale (VRS) on a scale of 0-10 (where 0 no pain, and 10 worst imaginable pain).

  6. Time of first rescue analgesia

    Time frame: 6 hours postoperatively

    Time of first rescue analgesia will be recorded from the end of surgery till first dose of opioid administrated.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya M Abo Zied, Master

CONTACT

[email protected]

00201126720605

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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