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

Phase 4

Completed

• Conditions: Cataract surgery; Anaesthesiology - Pain management; Eye - Diseases / disorders of the eye; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12614000545662
• Lead Sponsor: Hoda Alsaid Ahmed Ezz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the duration of analgesia indicated by the first time for rescue analgesic (measured from the time of local anesthetic injection to time of feeling of moderate or severe pain) as assessed using visual analogue score. [Pain was assessed during and after surgery at 30, 60, 90 minutes 2, 3, 4, 6 and 8 hours postoperatively, using Visual Analogue Score (VAS). 0 = no pain, to 10 = maximum pain, 1-3 = mild pain, 4 - 6 = moderate pain, > 6 = severe pain. ]