FentanylNCT07141589
Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries
A study testing Lidocaine + Bupivacaine + Hyaluronidase, Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase and Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase in people with Fentanyl and Ketorolac, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of ketorolac and fentanyl as adjuvants to local anesthetics for anterior segment surgeries of the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lidocaine + Bupivacaine + Hyaluronidase, Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase and Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2024to 25 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Aya M Abo Zied, Master, 00201126720605, Ayamezoo111@gmail.com
Mohammad Y Mostafa, MD
About this study
Official title: Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries, A Prospective Double-blinded Randomized Controlled Study
This study aims to compare the efficacy of ketorolac and fentanyl as adjuvants to local anesthetics for anterior segment surgeries of the eye.
Read the 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
- Being tested
- Lidocaine + Bupivacaine + Hyaluronidase, Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase, Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine + Bupivacaine + HyaluronidaseDrug
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 + HyaluronidaseDrug
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 + HyaluronidaseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 minutes after injection
Secondary outcomes (6)
Heart rate
Intraoperative heart rate will be recorded every 5 minutes in beats per minute.
Measured: Intraoperatively
Blood pressure
Intraoperative blood pressure will be recorded every 5 minutes in mmHg.
Measured: Intraoperatively
Onset of globe akinesia
The onset of lid akinesia will be the elapsed time between the peribulbar injection and partial loss of lid movement.
Measured: 10 minutes after injection
Onset of corneal anesthesia
The onset of anesthesia will be defined as the time interval between performing the block and loss of corneal sensation.
Measured: 1 minute after injection
Degree of pain
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).
Measured: 6 hours postoperatively
Time of first rescue analgesia
Time of first rescue analgesia will be recorded from the end of surgery till first dose of opioid administrated.
Measured: 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start25 Aug 2024
- Primary completion25 Nov 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FentanylStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Abo Zied, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141589
- Sponsor's protocol ID
- MD-264-2024
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.