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.: PACTR202206633862234 Date of Approval: 21/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Sub-Tenon's versus peribulbar anesthesia on postoperative nausea and vomiting in muscle traction ophthalmic surgeries in adults. A comparative randomized control study
Official scientific title Effect of Sub-Tenon's versus peribulbar anesthesia on postoperative nausea and vomiting in muscle traction ophthalmic surgeries in adults. A comparative randomized control study
Brief summary describing the background and objectives of the trial Postoperative nausea and vomiting (PONV) are distressing and common problems usually associated with ophthalmic surgeries specially those involving manipulation of extraocular muscles as squint or buckling operations, with an incidence from 46 to up to 85%. PONV can result in delayed discharge unexpected hospitalization and increasing medical costs. Patient discomfort during muscle traction in squint operations, prolonged duration in scleral buckling surgery in addition the unpredictable and uncomfortable nature of such surgery all limited the use of regional block alone. Hence, general anaesthesia is usually combined with regional anaesthesia and was shown to reduce these drawbacks, however it adds to the increased incidence of PONV as a side effect of general anesthesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Anesthesia regional block
Anticipated trial start date 01/01/2022
Actual trial start date 30/01/2022
Anticipated date of last follow up 10/12/2023
Actual Last follow-up date 30/12/2023
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status 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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group General anesthesia without regional anesthesia For the time of operation General atnesthesia only 14 Active-Treatment of Control Group
Experimental Group regional anesthesia block Articaine 4% 4ml , without epinephrine and with 30IU hyaluronidase added will be slowly injected Before starting the operation after general anesthesia blunt Westcott scissors is used to make a small `nick' in the inferonasal conjunctiva 5 mm from the limbus, and a Stevens cannula (BD Visitec Sub-Tenon's cannula 1.1 3 25 mm) is then introduced, passing through Tenon's fascia and the intermuscular septum. Subtenon block 14
Experimental Group Regional anesthesia block articaine 4% 5-7 mlwithout epinephrine and with 30IU hyaluronidase added will be slowly injected Befire the ooeration and after general anesthesia Peribulbar block group, single percutaneous injection will be performed using a 25-G 16-mm short-bevel needle, the injection site is in the inferior orbital edge and in the same line as the inferior lacrimal canaliculus, the needle is advanced in an antero-posterior direction for half of its length and then obliquely in the direction of the optical foramen. 14
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18 to 65 years, of both sexes. ASA I, II. patients undergoing muscle traction eye surgeries (buckling). Patient refusal. Uncooperative patient. Impaired mental status, communication difficulty as deafness or language barrier. ASA III-IV Patients <18 years, >65 years Axial eye length >28 mm. Clotting and coagulation abnormalities. ophthalmitis or inflammatory eye pathology raised IOP eye injury single eye allergy to amide type local anaesthetic patients known to have reduced plasma cholinesterase concentrations (reduced articaine metabolism) Patient had received an antiemetic drug or a drug with antiemetic properties during the 24 h before anaesthesia. Patient had a body mass index ≥36. Pregnant or breastfeeding women. patient had a condition requiring chronic opioid use patient had history of GIT pathology (gastritis, hematemesis, peptic ulcer). Patients on corticosteroids therapy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 17/04/2022 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kasr al ainy, el manial street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The percent of patients who experienced nausea and vomiting over the first 24 hrs postoperative in the Sub-tenon’s block group compared with Peribulbar block group and general anesthesia group in the first 24 hrs after extubation, number of patients who required antiemetic therapy.
Secondary Outcome Compare postoperative analgesia using VRS at 1, 2, 4,6, 8, 12, and 24 hrs after extubation in all groups
Secondary Outcome Compare Intraoperative analgesia in each group; by measuring systolic, diastolic and mean BP, HR at induction (T0), immediately after induction (T1), at incision (T2), and every 15 min till the end of the procedure and serum cortisol and glucose level (baseline and 30 mins after surgery and at end of surgery). Immediatelly after induction, every 15 min till the end of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University faculty of medicine Al kasr Al Ainy street, el Manyal cairo Cairo 111562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university faculty if medicine El kasr Al Ainy street, el Manial Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reem nasser mohammed fathy el ghandour 13 gaber bn hayn street nasr city Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Reem El ghandour Reemelghandour1@yahoo.com 01281367637 13 gaber bn hayan street nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer department of anesthesia faculty of medicine cairo university
Role Name Email Phone Street address
Scientific Enquiries Ashraf Mounir Amin Amounir_2007@yahoo.com 01001839500 El tayarn street nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anesthesia department cairo university
Role Name Email Phone Street address
Principal Investigator Tamer Fayez safaan Safan.tamer@yahoomail.com 01223337850 El mohandseen street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of Anesthesia depart ment cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes participant data that underlie the results reported in this article Study Protocol 2 years Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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