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CTRI Number  CTRI/2025/02/080063 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Too see the effect of local anaesthetic irrigation on pain after mastoidectomy  
Scientific Title of Study   Effect of intraoperative local anaesthetic irrigation on postoperative pain after mastoidectomy in adult patients : a randomised 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  Rahul kasaudhan 
Designation  Junior resident  
Affiliation  All india institute of medical science , patna  
Address  B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Sciences Patna Phulwarisharif Patna BIHAR India Patna BIHAR 801507 India

Patna
BIHAR
801507
India 
Phone  7488442712  
Fax    
Email  kasaudhanrahul.rk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nishant sahay 
Designation  Professor  
Affiliation  All india institute of medical science , patna  
Address  B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Science Patna Phulwarisharif Patna BIHAR India Patna BIHAR 801507 India

Patna
BIHAR
801507
India 
Phone  9431184516  
Fax    
Email  nishantsahay@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishant sahay 
Designation  Professor  
Affiliation  All india institute of medical science , patna  
Address  B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Science Patna Phulwarisharif Patna BIHAR India Patna BIHAR 801507 India

Patna
BIHAR
801507
India 
Phone  9431184516  
Fax    
Email  nishantsahay@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science Patna 
 
Primary Sponsor  
Name  All India Institute of Medical Science Patna 
Address  All India Institute of Medical Science Patna, Phulwarisharif, Patna, India Bihar, PIN 801507, India  
Type of Sponsor  Government 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 Rahul Kasaudhan  All India Institute of Medical Science Patna   Department of Anaesthesiology, All India Institute of Medical Sciences Patna, Phulwarisharif Patna BIHAR Patna BIHAR
Patna
BIHAR 		 7488442712

kasaudhanrahul.rk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Patna 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  Lidocaine group  0.2% 500 ml lidocaine to a maximum dose of 30mg/kg of total body weight will be used as irrigation during mastoidectomy as an irrigation fluid during irrigation till the end of surgery. 
Comparator Agent  Norma saline group  Normal saline will be used for irrigation during mastoidectomy in control patients till the end of surgery.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA PS: 1-2
BMI 18-25 kg/m 2 
 
ExclusionCriteria 
Details  Allergic to local anaesthetic agent
History of chronic headache or any chronic facial pain 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the intensity of postoperative pain using the
numerical rating scale (NRS) at 1 hour after extubation.  		 Pain assesment at 1 hour after extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the intensity of postoperative pain using the numerical rating scale
(NRS) at 3hr, 6hr, & 16 hour after surgery.
To compare time to first rescue analgesic.
To compare the total dose of rescue analgesics used
To compare post operative nausea vomiting after 6 hour. 		 Pain at 3 hours, 6 hour & 16 hour . 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   18/02/2025 
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="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  
Opioids are routinely used to treat moderate to severe acute pain, but are associated with analgesic
tolerance, addiction, adverse effects like sedation, drowsiness, respiratory depression, nausea,
vomiting, hypotension, constipation etc. Lidocaine irrigation may be beneficial in reducing postoperative pain following mastoidectomy. This research can also evaluate the impact of irrigation on postoperative nausea and vomiting, which are common side effects of mastoidectomy. With further clinical trials, this approach could potentially facilitate the transition of mastoidectomy into a day-care surgical procedure.
 
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