Adjuvant, Anterior Segment Surgeries, Fentanyl, Ketorolac, Peribulbar Block
Conditions
Brief summary
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.
Interventions
DRUGLidocaine + Bupivacaine + Hyaluronidase
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.
DRUGFentanyl + Lidocaine + Bupivacaine + Hyaluronidase
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.
DRUGKetorolac + Lidocaine + Bupivacaine + Hyaluronidase
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of globe akinesia | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Intraoperatively | Intraoperative heart rate will be recorded every 5 minutes in beats per minute. |
| Blood pressure | Intraoperatively | Intraoperative blood pressure will be recorded every 5 minutes in mmHg. |
| Onset of globe akinesia | 10 minutes after injection | The onset of lid akinesia will be the elapsed time between the peribulbar injection and partial loss of lid movement. |
| Degree of pain | 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 of first rescue analgesia | 6 hours postoperatively | Time of first rescue analgesia will be recorded from the end of surgery till first dose of opioid administrated. |
| Onset of corneal anesthesia | 1 minute after injection | The onset of anesthesia will be defined as the time interval between performing the block and loss of corneal sensation. |
Countries
Egypt
Contacts
Primary ContactAya M Abo Zied, Master
Outcome results
None listed