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.: PACTR202202836176096 Date of Approval: 22/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Guided Pterygopalatine Fossa Block in Functional Endoscopic Sinus Surgery
Official scientific title Perioperative Outcome of Ultrasound Guided Pterygopalatine Fossa Block in Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Pterygopalatine fossa block used for haemodynamic stability during FESS ,Controlled hypotension intraoperatively for better visualization of the surgical field to avoid complications resulting from impaired visibility due to excessive bleeding and intraoperative analgesia It also eliminates the general anesthesia emergence phenomena, reduces the incidence of postoperative nausea and vomiting (PONV), and facilitates patient’s discharge by providing prolonged postoperative pain relief. The aim of this trial is to assess the effect of PPF block on the hypotensive drugs required to control the hemodynamics and improve surgical field conditions during FESS surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2022
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group General anesthesia and Pterygopalatine Fossa Block bilateral pterygopalatine fossa block using 4ml 0.25% bupivacaine after induction of general anesthesia. Once Ultrasound-guided pterygopalatine fossa block by high-frequency linear probe 60
Control Group General anesthesia only Induction of GA will be carried out using fentanyl (1 µg/kg) and propofol 2mg/kg intravenous (iv). Endotracheal intubation will be facilitated by rocuronium bromide 0.6 mg/kg i.vrelaxant maintenance by isoflurane in a mixture of oxygen and air Once Routine general anesthesia technique 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists (ASA) class I or II scheduled for elective functional endoscopic sinus surgery (FESS). History of allergy or contraindication to any of the studied drugs. Patients for whom pterygopalatine fossa block is contraindicated Patient refusal. Patients with fascial anomalies. Patients with coagulation abnormalities or on antiplatelet medication within the past 2 weeks Skin infection at the injection site Patient with invasive fungal sinusitis or revision surgery Obese patients with BMI more than 35 Kg/m2. Patient with allergic polyps on systemic steroids Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 16/12/2021 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Heart rate will be continuously monitored and recorded at the following periods: preoperative, after induction of anaesthesia, at entrance of endoscope, then every 15 min till the end of the surgery
Primary Outcome Mean arterial blood pressure will be continuously monitored and recorded at the following periods: preoperative, after induction of anaesthesia, at entrance of endoscope, then every 15 min till the end of the surgery
Secondary Outcome End tidal expired isoflurane concentration Will be continuously monitored and recorded after 15 min from the induction of anaesthesia, then every 15 min till the end of the surgery
Secondary Outcome Total Fentanyl requirement During the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Otorhinology department Faculty of medicine Kafr elsheikh University hospital Elgeesh Street Kafr elsheikh Kafre lsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Donia Hany Saad Aboadma Smouha in front of pharous university somed2 Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Kafr elsheikh University hospital Elgeesh Street Kafr elsheikh 33511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Donia Hany Saad Aboadma Smouha in front of pharous university somed2 Alexandria 21648 Egypt
Ahmed Mansour Abdou 17 champlion street elmesallah Alexandria 21521 Egypt
Moustafa Abdelaziz moustafa 17 champlion street elmesallah Alexandria 21521 Egypt
Saad eldousouky elzayat Elgeesh Street Kafre lsheikh 33511 Egypt
Aly Mahmoud moustafa ahmed 17 champlion street elmesallah Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Ahmed Abdou am9277287@gmail.com 00201119277287 17 Champlion street elmesallah Alexandria
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria university
Role Name Email Phone Street address
Scientific Enquiries Ali Mahmoud medical_all4one@hotmail.com 00201224129850 17 Champlion street elmesallah Alexandria
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of anaesthesia and surgical intensive care faulty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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