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Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries

ConditionsFentanylKetorolacAdjuvantPeribulbar BlockAnterior Segment Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

This study aims to compare the efficacy of ketorolac and fentanyl as adjuvants to local anesthetics for anterior segment surgeries of the eye.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

168 Participants
are divided into 3 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Fentanyl groupExperimental treatment 1 intervention
Group C: Ketorolac groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
10 minutes after injection

Secondary outcomes

1

Heart rate

Intraoperative heart rate will be recorded every 5 minutes in beats per minute.

Time frame
Intraoperatively
2

Blood pressure

Intraoperative blood pressure will be recorded every 5 minutes in mmHg.

Time frame
Intraoperatively
3

Onset of globe akinesia

The onset of lid akinesia will be the elapsed time between the peribulbar injection and partial loss of lid movement.

Time frame
10 minutes after injection
4

Onset of corneal anesthesia

The onset of anesthesia will be defined as the time interval between performing the block and loss of corneal sensation.

Time frame
1 minute after injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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