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.: PACTR202607625641955 Date of Registration: 02/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Sub-Tenon versus peribulbar anaesthesia on postoperative nausea and vomiting in muscle traction ophthalmic surgeries in adults. A comparative randomized control study.
Official scientific title Effect of Sub-Tenon versus peribulbar anaesthesia 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. Sub-tenon’s block was proven to be more safe compared to peribulbar or retrobulbar block, and previous studies showed that both techniques reduced PONV compared to general anesthesia. (13-15). Our study will compare whether sub-tenon’s or peribulbar block using articane combined with general anesthesia has better effect on perioperative nausea and vomiting, intra and postoperative analgesia and intraoperative OCR in muscle traction eye surgeries in adults. We also hypothesize that both will have better outcome than patients receiving general anesthesia alone without block.
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 Compare effect of peribulbar versus subtenon block on postoperative outcome
Anticipated trial start date 01/04/2022
Actual trial start date 01/06/2024
Anticipated date of last follow up 01/01/2025
Actual Last follow-up date 01/04/2025
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants)
Recruitment status Completed
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
Experimental Group Subtenon block combined with general anesthesia 4 ml articaine 4% , without epinephrine and with 30IU hyaluronidase added At the begining of operation , before administration of general anaesthesia till first 24 hr Subtenon block was performed aseptically with the skin around the eye prepared with povidone- iodine 5% solution and an adherent sterile plastic drape placed around the appropriate eye. Three drops of 1% amethocaine (local anesthetic) were added topically to the eye undergoing surgery and block was performed at least two minutes after. The block was performed by a senior experienced anesthetist. In Sub-Tenon's block group, blunt Westcott scissors was 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) was introduced, passing through Tenon's fascia and the intermuscular septum. 14
Experimental Group Peribulbar block combined with general anaesthesia 5-7 ml articaine 4% At the begining of operation before general anaesthesia till first 24 hr In Peribulbar block group, single percutaneous injection was 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 was advanced in an antero-posterior direction for half of its length and then obliquely in the direction of the optical foramen. After negative aspiration,5-7 ml articaine 4%, without epinephrine and with 30IU hyaluronidase added was slowly injected in both groups until there was complete drop and fullness of the upper eyelid. Intermittent compression was applied for 10 min in both groups, using a Honan balloon set at 30 mmHg. 14
Control Group General anaesthesia only without block No block the general anesthesia time is the duration of operation and monitor at first 24 hr General anesthesia only No block and no intervention 14 Placebo
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. 61  ophthalmitis or inflammatory eye pathology  raised IOP  eye injury  single eye  allergy to amide type local anesthetic  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 anesthesia.  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: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),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 at the faculty of medicine cairo university
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy Street, Al-Manial, Cairo, Egypt Cairo 11956 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 and required antiemetic medication in the three groups. At end of operation , then at 1hr, 2hrs, 4 hrs, 6hrs ,8 hrs, 12 hrs and 24 hrs postoperative
Secondary Outcome Efficacy and Complications with each block following block till 24 hrs postoperative
Secondary Outcome Need for postoperative analgesia. At end of operation , then at 1hr, 2hrs, 4 hrs, 6hrs ,8 hrs, 12 hrs and 24 hrs postoperative .
Secondary Outcome Intraoperative analgesia; by measuring hemodynamic variables (BP and HR). Preoperative, post induction of GA , post incision then every 15 mins till end of operation
Secondary Outcome Incidence of occulocardiac reflex and need for atropine each group Preoperative, post induction of GA , post incision then every 15 mins till end of operation
Secondary Outcome serum cortisol and glucose level baselline, 30 mins after surgery and at end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Cairo University Kasr Al Ainy Street, Al-Manial Cairo 11956 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine cairo university Kasr Al-Ainy Street, Al-Manial Cairo 11956 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine cairo university Kasr Al Ainy Faculty of Medicine, Al-Manial Cairo 11956 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reem nasser elghandour 13 gaber ibn hayan street , nasr city Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Reem Elghandour reemnasserelghandour93@gmail.com 201281367637 13 gaber ibn 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 Tamer Fayez safaan tamerfayezsafan@gmail.com +201223337850 63 gamet eldwal street almohandesin
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of anesthesia faculty of medicine cairo university
Role Name Email Phone Street address
Principal Investigator Kareem Nagy abbas Dr.kareemnagy88@gmail.com +201001223232 94 tayaran street nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia faculty of medicine cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data Statistical Analysis Plan Following Any purpose collected during the trial, after publication deidentification Statistical Analysis Plan Following publication Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 11/06/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/06/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 02/07/2026 PACTR Admin Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s)