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Effect of Ultra-Low-Dose Naloxone Added to Fentanyl and Lidocaine for Peribulbar Anesthesia in Cataract Surgery: A randomized prospective clinical trial.

Effect of ultra-low-dose naloxone added to fentanyl- lidocaine for peribulbar anesthesia on the duration of post-operative analgesia in Patients undergoing cataract surgery.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000545662
Enrollment
60
Registered
2014-05-21
Start date
2013-05-13
Completion date
2013-11-11
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

the aim of the present study was to evaluate the effect of addition of ultra-low-dose of naloxone to fentanyl and lidocaine for peribulbar anesthesia on the quality of the block and the duration of postoperative analgesia in patients undergoing cataract surgery.

Interventions

Interventions: The patients were randomized into 2 groups (30 patients each) to undergo peribulbar anesthesia. Group I: patients received 50 micrograms fentanyl and lidocaine 2% with hyaluronidase 15 IU/ml. Group II: patients received 100 nanograms naloxone, 50 micrograms fentanyl and lidocaine 2% with hyaluronidase 15 IU/ml. Preoperatively , no premedication was given and, intravenous cannula was inserted. The patients were monitored continuously for ECG, heart rate, pulse oximetery. Arterial

Interventions: The patients were randomized into 2 groups (30 patients each) to undergo peribulbar anesthesia. Group I: patients received 50 micrograms fentanyl and lidocaine 2% with hyaluronidase 15 IU/ml. Group II: patients received 100 nanograms naloxone, 50 micrograms fentanyl and lidocaine 2% with hyaluronidase 15 IU/ml. Preoperatively , no premedication was given and, intravenous cannula was inserted. The patients were monitored continuously for ECG, heart rate, pulse oximetery. Arterial blood pressure (ABP) was measured non-invasively every 5 minutes. Topical local anesthetic (benoxinate hydrochloride) was applied to the eye then, with the eye in the primary gaze position, a 25-gauge short bevel needle was inserted trans-conjunctivally at the junction between the medial two thirds and lateral third of the inferior orbital rim in a strictly posterior direction. Depth of needle insertion was limited to 25mm. The anesthetic mixture was injected after aspiration test and, the injection was continued until subconjunctival edema and lid fullness appeared. Intermittent digital compression was applied to lower the intraocular pressure until sufficient motor block occurred. Pain was assessed during and after surgery at 30, 60, 90 minutes 2, 3, 4, 6 and 8 hours post-operatively, using Visual Analogue Score (VAS). 0 = no pain, to 10 = maximum pain, 1-3 = mild pain, 4 - 6 = moderate pain, > 6 = severe pain. Patients with moderate or severe pain received diclofenac sodium 75 mg intramuscular injection.

Sponsors

Hoda Alsaid Ahmed Ezz
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

adult patients of both sexes, ASA I and II scheduled for open globe cataract surgery in the Ophthalmology Department Tanta University Hospital were included.

Exclusion criteria

Exclusion criteria included clotting abnormalities and patients on anticoagulant therapy, impaired mental status, patients with communication difficulties, uncontrolled movements or tremors e.g. Parkinsonism, inability to lie flat, one eyed patients, uncontrolled glaucoma, recent surgical procedure on the same eye, high myopia, with axial length more than or equal 26 mm as detected by ultrasonography, and allergy to hyaluronidase or local anesthetics.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026