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CTRI Number  CTRI/2025/03/082207 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   randomised control trial 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   It is a study to see the analgesic effect of ultrasound guided superficial cervical plexus block in mastoid surgeries wherein the efficacy of local anaesthetic is compared. 
Scientific Title of Study   Comparative evaluation of analgesic effect of ultrasound guided superficial cervial plexus block in mastoid surgeries. 
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 Ashish Kumar Kannaujia 
Designation  Professor 
Affiliation   
Address  department of Anaesthesiology Sanjay Gandhi Postgraduate Institute Of Medical Sciences, halibut mawaiya, raeberelli road, 226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  9451982660  
Fax    
Email  ashishkannaujia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Ashish Kumar Kannaujia 
Designation  Professor 
Affiliation   
Address  Department Of Anaesthesiology Sanjay Gandhi Postgraduate Institute of Medical Sciences, halibut mawaiya, raeberelli road, Lucknow 226014.


UTTAR PRADESH
226014
India 
Phone  9451982660  
Fax    
Email  ashishkannaujia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Ashish Kumar Kannaujia 
Designation  Professor 
Affiliation   
Address  Department of Anaesthesiology Sanjay Gandhi Postgraduate Institute of medical sciences, haibut dawaiya, raeberelli road 226014


UTTAR PRADESH
226014
India 
Phone  9451982660  
Fax    
Email  ashishkannaujia@gmail.com  
 
Source of Monetary or Material Support  
NONE 
 
Primary Sponsor  
Name  Sanjay Gandhi Postgraduate Institute of medical sciences 
Address  Department of anaesthesiology, Sanjay Gandhi Postgraduate Institute of medical sciences, halibut maw dawaiya, raeberelli, Lucknow 226014 
Type of Sponsor  Research institution and hospital 
 
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 Ashish Kumar Kannaujia  Sanjay Gandhi Postgraduate Institute of Medical SCciences  ENT operation theatre, department of Neuro-otology ENT, OT complex old building.
Lucknow
UTTAR PRADESH 
9451982660

ashishkannaujia77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical Committee  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 
Comparator Agent  total rescue analgesia in 24 hours in patients with ultrasound guided superficial cervical plexus block in mastoid surgery with dexamethasone  superficial cervical plexus block via ultrasound guidance in patients undergoing mastoid surgery with dexamethasone using .25% bupivacaine with 2ml or 8 mg dexamethasone. frequency- block placed once. block effect assessed for 24 hours 
Comparator Agent  total rescue analgesia namely 75 mg diclofenac slow iv in 24 hours in patients with ultrasound guided superficial cervical plexus block in mastoid surgery without dexamethasone used as additive.  superficial cervical plexus block via ultrasound guidance in patients undergoing mastoid surgery using .25% bupivacaine(8ml) without dexamethasone. frequency- block administered once, duration- followed for 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. ASA I and II patients.
2. Age between 18-70 years,
3. Both male and female patients.
4. Elective mastoid surgery under General Anaesthesia. 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Altered neck anatomy (Previous neck surgeries etc.)
3. Previous ear surgeries
4. Seizure disorder
5. Diabetes mellitus
6. Pregnancy and lactating females
7. Motion sickness
8. Local site infection
9. Allergy to drugs
10. Substance abuse
11. Migraine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia which will be assessed by the time of the first dose of rescue analgesia needed after block placement if VAS score is greater than four at baseline and at 24 hours.  at baseline
at 24 hours after block 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total analgesic consumption
2. Hemodynamic parameters intraoperatively & postoperatively
3. Incidence of post operative nausea & vomiting (PONV)
 
For 24 hours after placement of the block the patients shall be monitored 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   01/04/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Mastoid surgeries are one of the commonest ear surgeries performed globally. Tradi8onally these surgeries are performed under general anaesthesia and have several issues like risk of post opera8ve pain and PONV. For pain management intraopera8vely and postopera8vely opioids are the mainstay, however opioids have their own problems like postopera8ve respiratory depression, hypoxia and nausea vomi8ng. With development of mul8modal analgesia, various blocks have been advocated for beDer post opera8ve pain management like SCPB. However, there are limited studies enumera8ng the effect of superficial cervical plexus block (SCPB) in mastoid surgeries. The limita8on of SCPB is dura8on of analgesia so various aDempts have been made to increase the dura8on by adding adjuvant medica8on. Dexamethasone is a popular adjuvant for peripheral nerve blocks but these studies are mostly related to brachial plexus blocks. There is one study of use of dexamethasone in SCPB in thyroid surgeries where it has shown beDer pain control in the post opera8ve period. But we could not find any study of SCPB in which dexamethasone has been used in mastoid surgery.

The primary objec8ve of the study is to observe the dura8on of analgesia which will be assessed by the 8me of the first dose of rescue analgesia if VAS score is greater than four. The secondary objec8ves will be to see the total analgesic consump8on, hemodynamic parameters intraopera8vely and postopera8vely and the incidence of post opera8ve nausea and vomi8ng (PONV). Following approval from the ins8tu8onal ethics commiDee and registering the trial at CTRI, a wriDen informed consent will be obtained from the pa8ents. The study will be done for a period of 18 months. Pa8ents will undergo preanaesthe8c checkup a night before surgery. General anaesthesia with endotracheal tube inser8on (midazolam/fentanyl/propofol/vecuronium) will be done. Pa8ents will be divided in two groups.

Group B- 8ml(0.25%) bupivacaine Group D-8ml(0.25%)bupivacaine +2ml normal saline +2ml dexamethasone

The pa8ent will be in supine posi8on with the ipsilateral shoulder on the side of block propped up and the head turned to contralateral side. The site of interest will be painted and draped with the superficial cervical plexus block being placed in all asep8c precau8ons with a high frequency linear ultrasound probe (5-13 MHz). At the end during skin suturing all pa8ents will receive i.v ondansetron and paracetamol 1gm i.v. The residual neuromuscular blockade will be reversed a_er the pa8ent is fully responsive and awake.The pa8ent will be then shi_ed to post opera8ve care unit (PACU) for observa8on and monitoring. All the pa8ents will receive i.v paracetamol 1g/8 hourly in the postopera8ve period. Rescue analgesic will be provided with diclofenac 75mg in 100ml normal saline slow I.V over 30 minutes if the VAS score is greater than 4. All pa8ents will be monitored for the first dose of rescue analgesia, total dose of rescue analgesia consump8on, nausea vomi8ng and adverse events in the post operative period.

 
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