Cairo University
Cairo, 12613, Egypt
Location status: Recruiting
Location contact
Aya M Abo Zied, Master
CONTACT
Ghada A Sherif, MD
SUB_INVESTIGATOR
Mohammad Y Mostafa, MD
SUB_INVESTIGATOR
Tamer F Saafan, MD
SUB_INVESTIGATOR
NCT Number: NCT07141589
This study aims to compare the efficacy of ketorolac and fentanyl as adjuvants to local anesthetics for anterior segment surgeries of the eye.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cairo, 12613, Egypt
Location status: Recruiting
Aya M Abo Zied, Master
CONTACT
Ghada A Sherif, MD
SUB_INVESTIGATOR
Mohammad Y Mostafa, MD
SUB_INVESTIGATOR
Tamer F Saafan, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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)
Time frame: Intraoperatively
Intraoperative heart rate will be recorded every 5 minutes in beats per minute.
Time frame: Intraoperatively
Intraoperative blood pressure will be recorded every 5 minutes in mmHg.
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.
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.
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).
Time frame: 6 hours postoperatively
Time of first rescue analgesia will be recorded from the end of surgery till first dose of opioid administrated.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries, A Prospective Double-blinded Randomized Controlled Study
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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