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CTRI Number  CTRI/2025/08/093161 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 17/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study between two different approaches of Ultrasound guided Superior Laryngeal Nerve Block for Awake Fiberoptic Intubation in patients with anticipated difficult airway who are undergoing surgeries under general anaesthesia 
Scientific Title of Study   Parasagittal versus Transverse approach of Ultrasound-guided Superior Laryngeal Nerve Block for Awake Fiberoptic Intubation: a randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Ishita Sinha 
Designation  Post graduate trainee 1st year 
Affiliation  Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital 
Address  Department of Anesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT University, Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9589391388  
Fax    
Email  2487011@kims.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Laba Kumar Nayak 
Designation  Associate Professor 
Affiliation  Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital 
Address  Department of Anesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT Deemed to be University, Patia, Bhubaneswar


ORISSA
751024
India 
Phone  9439014811  
Fax    
Email  labakumar.nayak@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr. Laba Kumar Nayak 
Designation  Associate Professor 
Affiliation  Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital 
Address  Department of Anesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT Deemed to be University, Patia, Bhubaneswar


ORISSA
751024
India 
Phone  9439014811  
Fax    
Email  labakumar.nayak@kims.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kalinga Institute of Medical Sciences  
Address  KIMS hospital, KIIT university, KIIT Rd, Bhubaneswar- 751024, Odisha 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ishita Sinha  Kalinga Institute of Medical Sciences  Department of Anesthesiology, 3rd floor OT Complex, KIMS and Pradyumna Bal Memorial Hospital, KIIT Deemed to be University, Patia, Bhubaneswar
Khordha
ORISSA 		 9589391388

2487011@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kalinga Institute of Medical Sciences, KIIT university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound-guided Superior Laryngeal Nerve Block in awake Fiberoptic Intubation  Parasagittal versus transverse approach of ultrasound-guided Superior Laryngeal Nerve Block for awake Fiberoptic intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with anticipated difficult airway requiring Fiberoptic intubation
2. Patients weighing 45-80 kgs
3. ASA (American Society of Anaesthesiologists) grade I or II
4. Anticipated difficult airway which includes: limited movement of cervical vertebrae, airway insufficiency/ obstruction, maxillofacial deformity or trauma, small mandibular or mouth opening of less than 3 cms, modified Mallampatti class III or IV 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Patients with infection at puncture site
3. Patients with allergy to local anaesthetic drugs
4. Patients on antiplatelet therapy
5. Patients having bleeding or coagulation disorder 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the quality of airway anesthesia will be assessed, just during intubation, based on a 5 point scale of coughing and /or gagging response, by an observer, who is blinded to the technique of block  During endotracheal intubation 
 
Secondary Outcome  
Outcome  TimePoints 
1. Tube tolerance score
2. Mean arterial pressure (MAP) & Heart rate (HR)
3. Ramsay sedation score
4. Incidence of sore throat
5. Incidence of hoarseness 		 1. Tube tolerance score: just after intubation
2. MAP & HR at different time points: on entering the operation room (T0), immediately before endotracheal intubation (T1), immediately after endotracheal tube insertion into glottis (T2), 5 mins after intubation (T3)
3. Ramsay sedation score: during intubation & immediately after intubation
4. Incidence of sore throat: 1 hour & 24 hours after extubation
5. Incidence of hoarseness: before intubation, 1 hour & 24 hours after extubation  
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Superior laryngeal nerve blocks play a crucial role in optimising conditions for Fiberoptic- guided endotracheal intubation. While ultrasound- guided transverse approach of superior laryngeal nerve block is currently the standard technique, it often provides suboptimal visualisation of target structures. As a result, recent research interest has shifted towards a novel Parasagittal approach of ultrasound- guided superior laryngeal nerve block, which may offer improved anatomical clarity and block efficacy.
This study aims to compare the quality of anesthesia for intubation and effectiveness of the SLN block between the traditional transverse versus the emerging Parasagittal approach under Ultrasound- guidance. 
 
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