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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201712002860265 Date of Registration: 12/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Different additives in peribulbar block
Official scientific title Outcome values of adding sodium bicarbonate,Dexamethasone or fentanyl to local anesthetic in peribulbar block during Vitreoretinal surgeries. A Prospective Randomized Study
Brief summary describing the background and objectives of the trial Regional anesthesia is more preferable in vitreoretinal surgeries as it provides more patient comfort, less respiratory depression, less nausea and vomiting as a complication of general anesthesia, decrease postoperative pain and decrease narcotic & anesthetic consumption.The main goal is to compare effect of adding hyaluronidase , dexamethasone ,fentanyl or sodium bicarbonate to local anesthetic in peribulbar block during vitroectomy surgery and to study effect of each of them in changing intraocular pressure before and after giving local anesthesia and their effects on onset, duration of anesthesia, degree eye globe akinesia , postoperative pain control during surgery. First requirement for analgesia and any side effects
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2018
Actual trial start date 01/01/2018
Anticipated date of last follow up 01/06/2018
Actual Last follow-up date 01/06/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Not yet recruiting
Publication URL
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 Simple randomisation using a randomisation table from a statistics book 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 hyaluronidase in peribulbar block 75 iu once hyaluronidase is used with local anesthetic mixture in peribulbar block in vitreoretinal surgeries 30 Active-Treatment of Control Group
Experimental Group sodium bicarbonate in peribulbar block 1ml sodium bicarbonate8.4% once sodium bicarbonate is used as an adjuvant to local anesthetic in peribulbar block in vitreoretinal surgeries 30
Experimental Group fentanyl in peribulbar block 20 microgram once fentanyl is used as an adjuvant in peribulbar block in vitreoretinal surgeries 30
Experimental Group dexamethasone in peribulbar block 4mg once dexamethasone is used as an adjuvant to local anesthetic in peribulbar block in vitreoretinal surgeries 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Age: 40-60 years old. ¿ American society of anesthesiologist physical status (ASA): I-II. ¿ Operation: vitreoretinal surgery ¿ ASA :III-IV ¿ Uncooperative patient. ¿ Allergy to medication used. ¿ Patient refusal ¿ coagulopathy or history of anticoagulant therapy, ¿ patient with neurological manifestations ¿ failed regional anesthesia ¿ posterior staphyloma, ¿ disturbed conscious level, ¿ active respiratory disease, ¿ poor communication ability as deafness or mute . ¿ patients with excessive tremors or agitations, impaired orbital/periorbital sensations, and patients with glaucoma 40 Year(s) 60 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 27/12/2017 Faculty of Medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intraocular pressure, onset and duration of anesthesia and akinesia after the block
Secondary Outcome postoperative pain , firest analgesic requirement and side effects after the block
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Elgeish Street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta Universtiy Elgeish Street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Elgeish Street Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sherif Kamal Arafa El Bahr Street Tanta 31527 Egypt
Mona Blough El Morad Elgeish Street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Arafa sherifarafa1020@gmail.com 01005714014 El Bahr Street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesiology and ICU, Faculty of Medicine, Aswan University
Role Name Email Phone Street address
Public Enquiries Sherif Arafa sherifarafa1020@gmail.com 01005714014 El Bahr Street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesiology and ICU, Faculy of Medicine, Aswan University
Role Name Email Phone Street address
Scientific Enquiries Sherif Arafa sherifarafa1020@gmail.com 01005714014 El Bahr Street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesiology and ICU, Faculty of Medicine, Aswan University
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information