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.: PACTR201606001669349 Date of Approval: 09/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Peribulbar anesthesia
Official scientific title Fentanyl versus magnesium sulphate as adjuvants to peribulbar anesthesia in cataract surgery
Brief summary describing the background and objectives of the trial Regional anaesthesia is the technique of choice for the vast majority of patients undergoing cataract surgery. Among regional blocks, peribulbar block is safer in comparison to retrobulbar block due to a lesser incidence of serious complications such as brainstem anesthesia, globe perforation, and retrobulbar hemorrhage. A mixture of bupivacaine and lidocaine is the most frequently used local anaesthetic combination. In order to enhance the onset of akinesia and increased tissue diffusion, additives like hyaluronidase ,adrenaline , clonidine , corticosteroids , sodium bicarbonate and neuromuscular blocking agents , , have been used in peribulbar block. These agents are also not devoid of side-effects like allergic reaction, bradycardia, sedation, dryness of mouth, systemic neuromuscular blockade, etc. Until date, no one adjuvant is ideal for peribulbar block 1. Fentanyl is a narcotic that has been successfully used as an adjuvant to local anesthetics, prolonging its action with better analgesia and anesthesia , Magnesium is a physiological calcium channel blocker and noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors . It has been used with a local anesthetic solution in different regional anesthesia techniques to decrease the onset time of block and to increase the quality and duration of anesthesia . The aim of this study is to compare the effects of adding fentanyl and magnesium sulfate to peribulbar anesthesia in patients undergoing cataract surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Eye Diseases,Pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2016
Actual trial start date 17/05/2016
Anticipated date of last follow up 01/10/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
30913/05/16 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
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 Permuted block randomisation Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group ( C ) peribulbar block using 4 ml lidocaine 2% , 4 ml bupivacaine 0.5% , 1 ml hyaluronidase ( 150 IU ) and 1 ml normal saline. ( total volume 10 ml ). Once Peribulbar block 30 Active-Treatment of Control Group
Experimental Group Fentanyl group ( F ) 4 ml lidocaine 2% , 4 ml bupivacaine 0.5% , 1 ml hyaluronidase ( 150 IU ) and 20 ug fentanyl in 1 ml normal saline . ( total volume 10 ml ). Once Peribulbar block 30
Experimental Group Magnesium sulfate group (M) 4 ml lidocaine 2% , 4 ml bupivacaine 0.5% , 1 ml hyaluronidase ( 150 IU ) and 50 mg of magnesium sulfate in 1 ml of normal saline. ( total volume 10 ml ) Once Peribulbar block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 40 ¿ 70 years either gender ASA I-II undergoing cataract surgery Patient refusal coagulopathy history of anticoagulant therapy or allergy to local anesthetics axial length >28 mm posterior staphyloma uncontrolled hypertension disturbed conscious level mentally retarded patients active respiratory disease failure of proper communication as deafness patients with excessive tremors or agitations impaired orbital/periorbital sensations patients with glaucoma. 40 Year(s) 70 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 16/05/2016 Tanta University, Faculty of Medicine, research ethics committee, quality assurance unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Onset of sensory block will be assessed by abolition of the corneal reflex. When occurs
Primary Outcome ¿ Onset of akinesia ( the movements of eyelid (lid akinesia) and ocular muscles (globe akinesia). When occurs
Primary Outcome ¿ Akinesia score . at 30-s intervals until the block was considered adequate for surgery.
Secondary Outcome VAS score of pain at the time of injection 1h 2 h 4 h 6 h 12 hr 24 hr
Secondary Outcome ¿ Time of first analgesic request When occurs
Secondary Outcome ¿ Total consumption of rescue analgesia Once after 24 h postoperative
Secondary Outcome ¿ The duration of akinesia Every 15 min
Secondary Outcome ¿ Any side effect or complication of the block (hemorrhage, globe perforation, brain stem anesthesia, nausea, vomiting, dizziness) If occured
Secondary Outcome Sedation every 15 min for 2 h every 1 h for 6 h.
Secondary Outcome ¿ The overall patient satisfaction Once after 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU 10 Algeish street Tanta Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information