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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries, A Prospective Double-blinded Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07141589
- Acronym / sponsor ID
- MD-264-2024
- Conditions
- Fentanyl, Ketorolac, Adjuvant, Peribulbar Block, Anterior Segment Surgeries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 25 Nov 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Lidocaine + Bupivacaine + HyaluronidasePatients 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. |
| Fentanyl group | Experimental | Drug: Fentanyl + Lidocaine + Bupivacaine + HyaluronidasePatients 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 | Experimental | Drug: Ketorolac + Lidocaine + Bupivacaine + HyaluronidasePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine + Bupivacaine + HyaluronidasePatients 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 | Control group |
| Fentanyl + Lidocaine + Bupivacaine + HyaluronidasePatients 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 | Fentanyl group |
| Ketorolac + Lidocaine + Bupivacaine + HyaluronidasePatients 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. | Drug | Ketorolac group |
Primary outcome
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)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya M Abo Zied, Master (00201126720605, Ayamezoo111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of globe akinesia (time frame: 10 minutes after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.