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CTRI Number  CTRI/2024/08/072327 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 10/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Result of Bilateral Intranasal Transmucosal Sphenopalatine Ganglion Block for Postoperative pain in Functional Endoscopic Sinus Surgery.A Randomised Placebo Control Study 
Scientific Title of Study   Effect of Bilateral Intranasal Transmucosal Sphenopalatine Ganglion Block for Postoperative Analgesia in Funtional Endoscopic Sinus Surgery:A Randomised Placebo Control Study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kuna Kripa Rani  
Designation  PG Anaesthesia 
Affiliation  ABVIMS AND DR RML HOSPITAL NEW DELHI 
Address  Department OF Anaesthesia ABVIMS and DR RML Hospital, New Delhi 110001 India

Central
DELHI
110001
India 
Phone  7989069470  
Fax    
Email  vennvla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Namita Arora 
Designation  Professor 
Affiliation  ABVIMS AND DR RML HOSPITAL NEW DELHI  
Address  Department of Anaesthesia,ABVIMS and DR RML Hospital,New Delhi,110001

Central
DELHI
110001
India 
Phone  9868219619  
Fax    
Email  drnamitaarora@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Namita Arora 
Designation  Professor 
Affiliation  ABVIMS AND DR RML HOSPITAL NEW DELHI  
Address  Department of Anaesthesia,ABVIMS and DR RML Hospital,New Delhi,110001

Central
DELHI
110001
India 
Phone  9868219619  
Fax    
Email  drnamitaarora@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS AND DR RML Hospital,Baba Kharak Singh Marg,Near Gurudwara Bangla Sahib,Connaught Place,New Delhi,110001 
 
Primary Sponsor  
Name  ABVIMS and DR RML Hospital 
Address  ABVIMS and DR RML HOSPITAL, New Delhi -110001 
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 Kuna Kripa Rani  ABVIMS AND DR RML HOSPITAL   Room no 304, Department of Anarsthesia ,ABVIMS AND DR RML Hospital, Baba Kharak Singh Marg, near Gurudwara Bangla Sahib, Connaught Place, New Delhi -110001
Central
DELHI 		 7989069470

vennvla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ABVIMS and Dr RML Hospital New Delhi Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj 0.5% Bupivacaine   A 10cm long sterile swab will be soaked in 3ml of 0.5% Bupivacaine and placed there for 10 minutes  
Comparator Agent  Normal saline   A 10cm long sterile swab soaked in 3ml of normal saline and placed there for 10 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adults aged 18 to 65years posted for elective functional endoscopic sinus surgery

2. ASA CLASS 1 and 2 
 
ExclusionCriteria 
Details  1. Patients with nasal deformities
2. Patients allergic to local anaesthetics
3. Patients with bleeding disorders
4. Patients with pregnancy  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to request first rescue analgesic in postoperative period according to VAS score  Post operative analgesia will be assessed using VAS score and if VAS score is greater than 3 then rescue analgesic in the form of Inj Tramadol 50mg IV will be given for next 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To determine total rescue analgesic consumption  If VAS score is greater than 3 then rescue analgesic in the form of Inj Tramadol 50mg IV will be given for 24 hours 
To assess hemodynamic parameters which includes Blood Pressure
Heart Rate
SpO2
Mean Arterial Pressure during intraoperative period  		 Baseline & every 15 minutes after induction will be assessed  
To note the total consumption of Fentanyl in intraoperative period   If heart rate raises greater than 20 percent of baseline then bolus dose of Inj Fentanyl 0.5mcg per kg will be given  
To note total consumption of antihypertensives in intraoperative period   Inj Nitroglycerin & Inj Metoprolol will be used in this study 
To document any complications of the block in intraoperative & postoperative period  Any complications will be noted  
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   22/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vennvla@gmail.com].

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 21-02-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is Randomised Placebo Control study to determine the effect of bilateral intranasal transmucosal sphenopalatine ganglion block for post operative analgesia in functional endoscopic sinus surgery.It will be conducted in the Department of Anaesthesiology,ABVIMS AND DR RML HOSPITAL,New Delhi-110001.The study will include adult patients of 18 to 65years of age (26 in each group) undergoing functional endoscopic sinus surgery.The primary outcome is to note the time taken to request first rescue analgesic in postoperative period.The secondary outcome is to determine the total rescue analgesic consumption in first 24 hours,To assess hemodynamic parameters during intraoperative period,To note total consumption of Fentanyl in intraoperative period,To note the total consumption of antihypertensives in intraoperative period,To document any complications of the block. 
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