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Trial registered on ANZCTR


Registration number
ACTRN12614000545662
Ethics application status
Approved
Date submitted
14/05/2014
Date registered
21/05/2014
Date last updated
7/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Ultra-Low-Dose Naloxone Added to Fentanyl and Lidocaine for Peribulbar Anesthesia in Cataract Surgery: A randomized prospective clinical trial.
Scientific title
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.
Secondary ID [1] 284606 0
Nil known
Universal Trial Number (UTN)
U1111-1156-8284
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract surgery 291908 0
Condition category
Condition code
Anaesthesiology 292253 292253 0 0
Pain management
Eye 292254 292254 0 0
Diseases / disorders of the eye
Anaesthesiology 292255 292255 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 289378 0
Treatment: Drugs
Comparator / control treatment
The active control group is group I in which the patients received 50 micrograms fentanyl and lidocaine 2% with hyaluronidase 15 IU/ml for peribulbar anesthesia.
Control group
Active

Outcomes
Primary outcome [1] 292118 0
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.
Timepoint [1] 292118 0
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.
Secondary outcome [1] 308231 0
The total volume of local anesthetic injected (in ml)
Timepoint [1] 308231 0
The volume injected in the first time + the volume of supplementary injection if needed
Secondary outcome [2] 308313 0
Time of onset of anaesthesia (minutes)
Timepoint [2] 308313 0
from the time of injection till the best akinesia score
Secondary outcome [3] 308314 0
Akinesia (immobility) of the globe and eye lids.
Timepoint [3] 308314 0
was scored every 2 minutes till the best akinesia score. We used an 18-point scale, which was the sum of six sub-scores for the four rectus muscles, levator palpebrae and orbicularis oculi from 0 to 3 (0 = no block, 1 = partial akinesia not sufficient for surgery, 2 = partial akinesia sufficient for surgery, 3 = complete akinesia)
Secondary outcome [4] 308316 0
occurrence of any complication (e.g. pain on injection, chemosis, diplopia, bradycardia, hypotension, nausea, vomiting …etc) were recorded.
Timepoint [4] 308316 0
during injection of the local anesthetic mixture.
after injection for up to 24 hours.
Secondary outcome [5] 308317 0
The intraocular pressure (mm Hg) using tonometry.
Timepoint [5] 308317 0
was measured before, 2 and 10 minutes after injection of local anesthetic mixture.
Secondary outcome [6] 308318 0
number of patients who needed supplemental injection
Timepoint [6] 308318 0
If after 10 minutes akinesia was insufficient 4 ml of the same solution was re-injected
Secondary outcome [7] 308319 0
The best akinesia score:
Timepoint [7] 308319 0
was the highest akinesia score obtained for each block without or before supplemental injection.

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients were randomized using closed opaque envelops into 2 groups (30 patients each)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using a computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For each group 26 patients were required for naloxone to increase the mean value of the first time for rescue analgesic by 20 % [30 minutes (0.5 hour)] based on a previous pilot study in our institute with 90 % power (a = 0.05 %) and standard deviation (SD) of 0.55. We used 30 patients in each group for more accurate statistical analysis.
The data were analyzed using SPSS (version 20), quantitative data were expressed as mean +/- SD (for age, weight, duration of surgery, onset, IOP, total akinesia score, best akinesia score, total injected volume and first time for rescue analgesic) and analyzed using independent-t-test for comparison between the two groups. F Test was used for comparison of IOP within the same group and Tukey's test is used as post hoc test. The VAS (did not follow the normal distribution was expressed as median (range) and Mann-Whitney U test was used for comparison between the two groups. While, the sex, number of patients who needed supplemental injection, and complications were expressed as (number %). P< 0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6051 0
Egypt
State/province [1] 6051 0
Tanta, EL Gharbia Goernorate

Funding & Sponsors
Funding source category [1] 289234 0
Self funded/Unfunded
Name [1] 289234 0
Hoda Alsaid Ahmed ezz
Rehab Said El Kalla
Address [1] 289234 0
El Geish street, Aesthesia and surgical intensive care Department, faculty of Medicine, Tanta Univerisity,Tanta, El Gharbia Governorate, Egypt
The postal code:31257
Country [1] 289234 0
Egypt
Primary sponsor type
Individual
Name
Hoda Alsaid Ahmed Ezz
Address
El Geish street, Aesthesia and surgical intensive care Department, faculty of Medicine, Tanta Univerisity,Tanta, El Gharbia Governorate, Egypt.
The postal code:31257
Country
Egypt
Secondary sponsor category [1] 287908 0
Individual
Name [1] 287908 0
Rehab Said El Kalla
Address [1] 287908 0
El Geish street, Aesthesia and surgical intensive care Department, faculty of Medicine, Tanta Univerisity,Tanta, El Gharbia Governorate, Egypt.
The postal code:31257
Country [1] 287908 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291004 0
The Research Ethics Committee of the Faculty of Medicine, Tanta, Egypt.
Ethics committee address [1] 291004 0
El Geish street, Aesthesia and surgical intensive care Department, faculty of Medicine, Tanta Univerisity,Tanta, El Gharbia Governorate, Egypt.
The postal code:31257
Ethics committee country [1] 291004 0
Egypt
Date submitted for ethics approval [1] 291004 0
Approval date [1] 291004 0
08/04/2013
Ethics approval number [1] 291004 0

Summary
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.
Trial website
Trial related presentations / publications
Ezz HAA, Elkala RS: Ultra-low-dose naloxone added to fentanyl and lidocaine for peribulbar anesthesia: A randomized controlled trial. Egyptian Journal of Anaesthesia 2015, 31(2):161-165.
Public notes

Contacts
Principal investigator
Name 48414 0
A/Prof Hoda Alsaid Ahmed Ezz
Address 48414 0
El Geish street, Aesthesia and surgical intensive care Department, faculty of Medicine, Tanta Univerisity,Tanta, El Gharbia Governorate, Egypt.
The postal code:31257
Country 48414 0
Egypt
Phone 48414 0
+20 1222768250
Fax 48414 0
Email 48414 0
hodaezz714@yahoo.com
Contact person for public queries
Name 48415 0
Prof Abd El Reheem M.Dowidar
Address 48415 0
El Geish street, Aesthesia and surgical intensive care Department, faculty of Medicine, Tanta Univerisity,Tanta, El Gharbia Governorate, Egypt.
The postal code:31257
Country 48415 0
Egypt
Phone 48415 0
+20 1223195015
Fax 48415 0
Email 48415 0
dr.dowidar47@hotmail.com
Contact person for scientific queries
Name 48416 0
Prof Abd El Reheem M. Dowidar
Address 48416 0
El Geish street, Aesthesia and surgical intensive care Department, faculty of Medicine, Tanta Univerisity,Tanta, El Gharbia Governorate, Egypt.
The postal code:31257
Country 48416 0
Egypt
Phone 48416 0
+20 1223195015
Fax 48416 0
Email 48416 0
dr.dowidar47@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary