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CTRI Number  CTRI/2026/01/100318 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Improving Pain Relief After Ear Surgery: Comparing Three Anesthesia Techniques 
Scientific Title of Study   Comparison of Ultrasound-guided superficial cervical plexus block, greater auricular nerve block and local infiltration for postoperative analgesia in tympanomastoid surgery: A Randomized 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 Usha Shukla 
Designation  Professor and Head of the Department of Anaesthesiology and Critical Care  
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai, Etawah 
Address  Department of Anaesthesiology and Critical Care, Third floor, Old OPD building, Uttar Pradesh University of Medical Sciences, Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  94122 01915  
Fax    
Email  ushashukla1970@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Usha Shukla 
Designation  Professor and Head of the Department of Anaesthesiology and Critical Care  
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai, Etawah 
Address  Department of Anaesthesiology and Critical Care, Third floor, Old OPD building, Uttar Pradesh University of Medical Sciences,Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  94122 01915  
Fax    
Email  ushashukla1970@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Usha Shukla 
Designation  Professor and Head of the Department of Anaesthesiology and Critical Care  
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai, Etawah  
Address  Department of Anaesthesiology and Critical Care, Third floor, Old OPD building, Uttar Pradesh University of Medical Sciences,Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  94122 01915  
Fax    
Email  ushashukla1970@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [] 
 
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 Anuj Sharma   Uttar Pradesh University of Medical Sciences   Room No. 329 3rd floor Old opd building Department of Anaesthesiology and Critical Care Uttar Pradesh University of Medical Sciences Saifai
Etawah
UTTAR PRADESH 		 9897955519

sharmaanuj50505@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics 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 
Intervention  Greater Auricular Nerve Block  Ultrasound guided Greater Auricular Nerve Block: The greater auricular nerve will be anesthetized using a similar local anaesthesia technique (5 ml bupivacaine 0.25 percent) 
Comparator Agent  Local infiltration   The surgical site will be infiltrated with local anaesthetic (10ml 0.25 percent bupivacaine) before incision 
Intervention  Superficial cervical plexus block   Ultrasound guided Superficial Cervical Plexus Block: A local anaesthetic (10 ml bupivacaine 0.25 percent) will be injected around the superficial cervical plexus under ultrasound guidance  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients aged 18 to 60 years
2 Patients undergoing tympanomastoid surgery
3 Patients under ASA I and ASA II physical status classification 
 
ExclusionCriteria 
Details  1 Refusal by patient for participation
2 Patients with previous history of migraine
3 Patients with previous history of head and neck surgeries
4 Patients with documented drug allergy to bupivacaine
5 If the duration of surgery is more than 4 hours.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare post operative pain scores (using Numerical rating scale) of patients who received
Ultrasound guided Superficial cervical plexus block, Ultrasound guided Greater auricular nerve block
and local infiltration in tympanomastoid surgeries. 		 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare total analgesic consumption in milligrams in first 24 hours.
2. To compare the incidence of post operative nausea & vomiting.
3. To compare patient satisfaction score using Likert Scale. 		 24 hours 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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   Phase 3 
Date of First Enrollment (India)   23/01/2026 
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="0"
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   This study aims to evaluate and compare the effectiveness of three different analgesic techniques used for pain control after tympanomastoid surgery. Postoperative pain after ear surgeries is often significant, and although opioids are commonly used, they are associated with adverse effects. Regional anesthesia techniques, particularly when performed using ultrasound guidance, can improve targeted pain relief and reduce the need for systemic analgesics. In this study, 99 patients aged 18 to 60 years undergoing tympanomastoid surgery will be randomly divided into three groups: one group will receive an ultrasound-guided superficial cervical plexus block, the second group will receive an ultrasound-guided greater auricular nerve block, and the third group will receive local anesthetic infiltration at the surgical site. Pain will be assessed at multiple intervals postoperatively using the Numerical Rating Scale, along with total analgesic consumption, incidence of postoperative nausea and vomiting, and patient satisfaction measured using a Likert scale. The study follows a randomized controlled design, with standard anesthetic management for all participants and clearly defined rescue analgesic protocols. Statistical analysis will include ANOVA for comparison of mean pain scores and Chi-square test for categorical outcomes. By directly comparing these commonly used analgesic methods, the study seeks to determine which approach provides the best postoperative pain control with minimal side effects, thereby improving recovery and overall patient comfort following tympanomastoid surgery. 
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