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This study aims to compare the efficacy of ketorolac and fentanyl as adjuvants to local anesthetics for anterior segment surgeries of the eye.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 10 minutes after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Intraoperative heart rate will be recorded every 5 minutes in beats per minute. | Intraoperatively |
| Blood pressure | Intraoperative blood pressure will be recorded every 5 minutes in mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya M Abo Zied, Master | Contact | 00201126720605 | Ayamezoo111@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 12613 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| 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. |
|
| 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. | 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. | 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). | 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. | 6 hours postoperatively |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| D006821 | Hyaluronoglucosaminidase |
| D005283 | Fentanyl |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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