Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001406377 Date of Approval: 01/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Regional Anesthesia of eye
Official scientific title Ketamine versus fentanyl as an adjuvant to single percutaneous peribulbar block in vitreoretinal surgeries
Brief summary describing the background and objectives of the trial Many patients with retinal disorders presented for vitroretinal surgeries had an increased perioperative risk with use of general anesthesia. Thus, single injection peribulbar regional block represent good alternative for those patients.However, use of local anesthesia is still restricted by short duration of the block,and low quality of both sensory and motor block. Recently use of additives to the usual used local anesthetics can overcome these obstacles by improving quality of both sensory and motor blockade,prolong duration of the block, and improving patients satisfaction. Opioids especially fentanyl are commonly added to local anesthetic solutions to increase intensity and duration of anesthesia by acting on opioid receptors present on the nerve terminals.Ketamine, a dissociative anesthetics N-methyl-D-aspartate(NMDA) antagonist, abolishes peripheral afferent noxious stimulation. This is prospective, randomized, controlled,and double blinded study that will be carried out in Tanta University Hospital. The aim of this study is to compare use of Fentanyl versus use of Ketamine as an adjunct to local anesthetics in peribulbar block in patients presented for vitro-retinal surgeries.The primary outcome is quality and duration of sensory and motor block. Additional outcomes include hemodynamic effects anf patients satisfaction. Patients included in the study will be,ASA I and II patients,and aged from 18 to 65 years. While, exclusion criteria consists of patients refusal, glaucoma patients, those with ocular infection, impaired orbital sensation, patients with coagulopathy, impaired consciousness, and mental retardation. All the maneuvers will be performed in the operating theatre. The patient will be monitored with electrocardiogram, pulse oximetry and noninvasive blood pressure. Patients will be randomly allocated (using closed envelop method) into two groups , 30 patients each.GroupI(Ketamine group)and Group II (Fentanyl group).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 08/07/2015
Actual trial start date 29/07/2015
Anticipated date of last follow up 24/12/2015
Actual Last follow-up date 24/12/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 71
Recruitment status Completed
Publication URL https://www.sciencedirect.com/science/article/pii/S1110184917301964
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated software Closed sealed envelop Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ketamine group 1mg/kg in 2ml saline added to equal volumes of 10ml of a 1:1 mixture of bupivacaine 0.5% and lidocaine 2%. single injection Single injection peribulbar block 30
Experimental Group Fentanyl group 2 ug/ ml of solution Once Single injection peribulbar block 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I and II patients Aged from 18 to 65 years old Scheduled for elective vitreoretinal surgeries Patients refusal of local anesthesia Glaucoma patients Patients with ocular infection Patients with impaired orbital sensation Patients with coagulopathy Patients with impaired consciousness Patients with mental retardation, recent myocardial infarction and uncontrolled hypertension. 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/08/2015 Research Ethical Committee, Faculty of Medicine, Tanta university
Ethics Committee Address
Street address City Postal code Country
Tanta Faculty of Medicine Tanta 31741 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of sensory and motor block Before procedure Every 1 minute in first 5 minutes after procedure Every 15 minutes in the next 1 hour Every 1 hour till 8 hours
Secondary Outcome Incidence of postoperative complication and hemodynamic changes Every one hour after end of surgey till 6 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital 1, Al geish st Tanta, Gharbya 31741 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University 1, Al geish st Tanta, Gharbya 31741 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University 1, Al geish st Tanta, Gharbya 31741 Egypt University
COLLABORATORS
Name Street address City Postal code Country
SamehAbdelkhalik Ahmed Ismaiel Saied st Tanta, Gharbya 31741 Egypt
Muhamed Gamal Almawy Alnady st Tanta, Gharbya 31741 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Abdelkhalik samehabdelkhalik1982@Gmail.com 01002977048 saied st
City Postal code Country Position/Affiliation
Tanta 31741 Egypt Lecturer at Tanta Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Mohamed Elfeqy Moh.mahmoudelfeqy1987@gmail.com 01225123291 Al bahr st
City Postal code Country Position/Affiliation
Tanta 31471 Egypt Manager of magrabi eye hospital Tanta
Role Name Email Phone Street address
Scientific Enquiries Abdelraheem Dowidar Dr.dowidar47@hotmail.com 0122 319 5015 saied st
City Postal code Country Position/Affiliation
Tanta 31471 Egypt Professor ofvanesthesiology and critical care Tanta University
REPORTING
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