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CTRI Number  CTRI/2024/11/077416 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Using Ultrasound Sphenopalatine ganglion block Improve Sinus Surgery: A Study on Pain Relief and Better Surgical Visibility. 
Scientific Title of Study   Bilateral sphenopalatine ganglion block using ultrasound in endoscopic sinus surgery for postoperative pain reduction and surgical field visualization during the surgery: a randomized controlled 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  Rithik joshy 
Designation  Post gradutae student 
Affiliation  AIIMS Bathinda 
Address  Department of anaesthesia aiims bathinda

Bathinda
PUNJAB
151001
India 
Phone  9447191403  
Fax    
Email  rithikjoshy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mayank Gupta 
Designation  Associate professor 
Affiliation  AIIMS Bathinda 
Address  Department of Anaesthesiology, AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8077754166  
Fax    
Email  mayankgupta6682@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mayank Gupta 
Designation  Associate professor 
Affiliation  AIIMS Bathinda 
Address  Department of anaesthesiology AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8077754166  
Fax    
Email  mayankgupta6682@gmail.com  
 
Source of Monetary or Material Support  
All India institute of medical science bathinda, Punjab,151001 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
Rithik Joshy  Department of anaesthesia , AIIMS Bathinda  Department of anaesthesia 151001
Bathinda
PUNJAB 		 9447191403

rithikjoshy@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: J320||Chronic maxillary sinusitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group a will receive sphenopalatine ganglion block   Group A will receive sphenopalatine ganglion with inj 4ml of 0.5% ropivacaine and 4mg/ml dexamethasone.  
Comparator Agent  Group B  Group B will not receive it. we will monitor the SPI monitor and the total opiod consumption between the both 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients between 18 to 65 years of age of either gender
ASA I and II scheduled for elective FESS under general anaesthesia  
 
ExclusionCriteria 
Details  Patients without consent.
Patients who are allergic to the study drug.
Patient bleeding diathesis.
PATIENT with a history of facial trauma.
Any systemic or local infection at the site of the needle insertion.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of ultrasound-guided sphenopalatine ganglion block on post-operative pain for 24 hours and surgical field visualization during surgery in patients undergoing functional endoscopic sinus surgery.  24 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To study the hemodynamic response to sphenopalatine ganglion block in FESS surgery  Intraoperatively 
• To compare the blood loss with the patients receiving sphenopalatine ganglion block & those who are not receiving block.  intraoperatively 
• To compare post-operative & intraoperative analgesia consumption among the patients receiving sphenopalatine ganglion block & those not receiving block.  24 hrs post operatively 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   10/01/2025 
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  

Evaluating the Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain and Surgical Visibility in Functional Endoscopic Sinus Surgery (FESS) Using Ultrasound Guidance.

Aim: To assess the impact of a bilateral sphenopalatine ganglion block administered via the suprazygomatic approach under ultrasound guidance on postoperative pain and the clarity of the surgical field during FESS.

Objectives

  • Primary Objective: To determine the effect of the block on postoperative pain (for 24 hours) and on surgical field visualization during FESS.
  • Secondary Objectives:
    • Assess hemodynamic response to the block.
    • Compare intraoperative blood loss between patients receiving and not receiving the block.
    • Analyze intraoperative and postoperative analgesic consumption.

Methodology

  • Study Design: Prospective, double-blinded, randomized control trial conducted over 18 months.
  • Participants: 70 adult patients (35 per group) aged 18–65 years, ASA physical status I and II, scheduled for elective FESS under general anesthesia.
  • Randomization: Participants are randomly divided into two groups:  GROUP A one receiving the sphenopalatine ganglion block with 0.5% ropivacaine and dexamethasone,  GROUP B the other not receiving the block.

Intervention

Patients undergo general anesthesia, and the block is administered under ultrasound guidance by an expert anesthetist using a 27-gauge needle for precise targeting. Both groups are monitored for hemodynamic stability, intraoperative bleeding (using Formme-Boezaart scale), and the surgical field’s visual clarity. Postoperative pain is assessed at 2, 6, and 12 hours using a numerical rating scale, and analgesia requirements are recorded.

Data Analysis

Data will be analyzed using SPSS software with appropriate statistical tests (t-tests, ANOVA, chi-square) to compare means, medians, and associations between groups, with significance set at p < 0.05.

Endpoints

  • Primary: Reduction in postoperative pain and improvement in surgical visualization.
  • Secondary: Hemodynamic stability, blood loss, and opioid consumption during surgery.

This study aims to enhance postoperative comfort and surgical efficiency in FESS through optimized pain management and surgical field visibility by using a targeted nerve block.

 
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