Fentanyl versus ketorolac added to peribulbar local anesthesia for anterior eye surgeries
Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries, A Prospective Double-blinded Randomized Controlled Study
This trial tests whether adding fentanyl or ketorolac to peribulbar local anesthesia helps adults having anterior segment eye surgeries have better pain control and eye immobility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07141589 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for anterior segment operations under peribulbar block are assigned to receive lidocaine/bupivacaine/hyaluronidase alone or with fentanyl or ketorolac as an adjuvant. The trial compares onset and quality of akinesia, duration of anesthesia, postoperative pain scores, and need for rescue analgesia while recording adverse effects. Fentanyl is an opioid adjuvant thought to improve akinesia and postoperative analgesia, whereas ketorolac is an NSAID that may reduce pain without opioid-related sedation or respiratory effects. Outcomes are collected during the operation and in the immediate postoperative period.
Who should consider this trial
Good fit: Adults aged 18 and older with ASA physical status I–III scheduled for anterior segment eye surgery under peribulbar anesthesia and without contraindications to the study drugs are ideal candidates.
Not a fit: Patients with NSAID allergy, contraindications to local anesthetics, coagulopathy or anticoagulation, impaired renal function, infection at the injection site, or those who require conversion to general anesthesia are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, adding fentanyl or ketorolac could provide longer pain relief and better eye immobility with fewer opioid-related side effects when ketorolac is used.
How similar studies have performed: Fentanyl has been used as an adjuvant in ocular regional blocks with reported improvements in akinesia and analgesia, while adding ketorolac to peribulbar anesthesia is less established though NSAIDs are effective for postoperative ocular pain.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Aya M Abo Zied, Master
- Email: Ayamezoo111@gmail.com
- Phone: 00201126720605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.