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.: PACTR202407555927073 Date of Approval: 18/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Optimizing Tracheostomy Anesthesia: A Comparative Study of Nerve Blocks
Official scientific title Optimizing Tracheostomy Anesthesia: A Comparative Study of Nerve Blocks
Brief summary describing the background and objectives of the trial Tracheostomy is a common surgical procedure, often performed in critically ill patients who require long-term mechanical ventilation. Adequate anesthesia and analgesia during tracheostomy are crucial to minimize patient discomfort, reduce complications, and improve patient safety. The traditional approach has been the use of bilateral superficial cervical plexus block, which can provide effective analgesia for the surgical site. The cervical plexus block (CPB) provides adequate anesthesia and analgesia for the head and neck area. Superficial cervical plexus block is a subcutaneous blockade of nerves of anterolateral neck. Sensory distribution of superficial and deep cervical plexus block is similar but superficial cervical plexus block has lesser complications. The cervical plexus (CP) originates from the anterior rami of the C1–C4 spinal nerves and gives rise to 4 terminal branches—greater auricular, lesser occipital, transverse cervical, and suprascapular nerves. The terminal branches provide sensory innervation to the skin and superficial structures of the anterolateral neck and sections of the ear and shoulder. superior laryngeal nerve (SLN) originates from the vagus nerve and splits in two branches: the external motor branch innervates the cricothyroid muscle of the vocal fold and the internal sensory branch provides sensory to the mucosa from the base of the tongue down to the upper aspect of the vocal folds and functions as the afferent limb of the cough and laryngeal spasm reflexes The principal goal of this trial is to assess the effectiveness of bilateral superficial cervical plexus block in isolation versus its combination with bilateral superior laryngeal nerve block for tracheostomy in sedated patients. Our aim is to ascertain whether the incorporation of the superior laryngeal nerve block can diminish coughing and laryngospasm, ultimately enhancing patient comfort and safety.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2024
Actual trial start date 01/06/2024
Anticipated date of last follow up 01/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilateral Superficial Cervical Plexus Block with Bilateral Superior Laryngeal Nerve Block sedation with midazolam .03 mg/kg just before the surgery 4 ml of 2% lidocaine on both sides . For the duration of surgery Patients in this group received bilateral superficial cervical plexus block and in addition, they received a bilateral superior laryngeal nerve block using 4 ml of 2% lidocaine on both sides . 60
Control Group Bilateral Superficial Cervical Plexus Block 6 ml of 2% lidocaine patients will be premeditated with midazolam .03 mg/kg just before the surgery for the duration of surgery Patients in this group received a bilateral superficial cervical plexus block using 6 ml of 2% lidocaine, that will be injected from both sides.. The technique involved locating the sternocleidomastoid muscle and injecting the anesthetic agents beneath it to provide analgesia to the surgical site . Additionally, a placebo solution will be administered to simulate the bilateral superior laryngeal nerve block. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligible patients must fall within the age range of 18 to 75 years have a clinical requirement for tracheostomy, be classified as American Society of Anesthesiologists (ASA) categories I to III possess the capability to give informed consent. contraindications to regional anesthesia a history of allergies to local anesthetics pregnancy inability to provide informed consent. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 14/01/2024 Ethics committe faculty of Medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
faculty of Medicine , 17 Champollion street , Elmessalah Alexandria Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of coughing and laryngospasm during the tracheostomy procedure. during the tracheostomy procedure.
Secondary Outcome postoperative pain scores, complications, and patient satisfaction. postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandra university hospital ENT department Faculty of Medicine Champollion street El khartoum square Alexandria 21131 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Alexandria university Faculty of Medicine 17 Champollion street Elmessalah Alexandria Alexandria 21131 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine faculty of Medicine ,17 Champollion street Elmessalah Alexandria Alexandria 21131 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Tarek Ismail Sabry Mohamed 152 Tiba street sporting Alexandria Alexandria 21631 Egypt
Rabab Saber Mahrous Baha el din Gatwary Smoha Alexandria Alexandria 21646 Egypt
Ahmed Abd Elmohsen Bedewy 9 Mohamed Fawzy Moaaz Street Smoha Alexandria 21646 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Asmaa Abd Elhameed asmaa.hassan@alexu.edu.eg +201001831803 165 Elhoreya road -Al ibrahimeya Qebli-Qesm Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Lecturer Medical Statistics Medical Research Institute Alexandria university
Role Name Email Phone Street address
Scientific Enquiries Rabab Saber roba98@hotmail.com +201223497339 Baha el din Gatwary Smoha Alexandria
City Postal code Country Position/Affiliation
Alexandria 21646 Egypt Professor of anesthesia and surgical intensive care Faculty of medicine Alexandria University
Role Name Email Phone Street address
Principal Investigator Tarek Ismail drtarek.anesth@gmail.com +201001467166 152 Tiba street sporting
City Postal code Country Position/Affiliation
Alexandria 21631 Egypt Assistant professor anesthesia and surgical intensive care Faculty of medicine Helwan university
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 individual deidentified participant data will be shared, additional related documents study protocol, statistical analysis plan will be shared.. The data will become available within 9 months after publication and for 24 months for researches who provide methodologically sound proposal for individual participant data meta-anlaysis. Informed Consent Form,Study Protocol 1 year open access will be permitted to get the data please send email to :asmaa.hassan@alexu.edu.eg (public relation)
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