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CTRI Number  CTRI/2024/09/074509 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of sphenopalatine ganglion block of both sides using ultrasound in alleviating pain of sinus surgery done using endoscope in comparison to those without block 
Scientific Title of Study   Analgesic efficacy of USG-guided bilateral sphenopalatine ganglion block versus no block in Endoscopic Sinus Surgery: A randomized control 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  Shagufta Naaz 
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology, AIIMS Patna, Phulwari Sharif, Patna. 801507

Patna
BIHAR
800007
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shagufta Naaz 
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology, AIIMS Patna, Phulwari Sharif, Patna. 801507

Patna
BIHAR
800007
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shagufta Naaz 
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology, AIIMS Patna, Phulwari Sharif, Patna. 801507

Patna
BIHAR
800007
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Patna, Phulwarisharif, Patna, Bihar, India, 801507 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  AIIMS Patna, Phulwari Sharif, Patna. 801507 
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 Shagufta Naaz  AIIMS Patna  Department of Anaesthesiology, AIIMS Patna, Phulwari Sharif, Patna
Patna
BIHAR 		 7765937919

drshaguftanaaz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIIMS-P  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral SPGB  After anaesthetising the patient, SPG blockade will be performed using ultrasound via suprazygomatic approach and 4 mL of 0.5% bupivacaine and 0.5 mcg/kg bodyweight dexmedetomidine in a volume of 1 ml (total solution of 5ml) to each SPG block site. The patient will be followed up for 24 h postoperatively to assess pain. 
Comparator Agent  No Bilateral SPGB   After anaesthetising the patient, no blocks will be administered.The patient will be followed up for 24 h postoperatively to assess pain. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA I and II
2. Patients between the ages of 18-60 years
3. Duration of surgery less than 3 hrs
4. Male and female
5. BMI 18-30kg/m2
 
 
ExclusionCriteria 
Details  1. History of severe liver, renal or cardiovascular disease or chronic pain disease
2. Pre-existing neurological or psychiatric illness
3. Any bleeding abnormality
4. Diagnosis of allergy to the study drug
5. Sensitivity to NSAIDs
6. History of alcohol or drug abuse
7. History of chronic use of analgesics, sedatives, opioids, or steroids
8. Pregnancy
9. patients who would not want to participate in the study
10. uncooperative (due to dementia, mental retardation, etc.)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative opioid requirement will be recorded  At 24 h postoperatively (Total opioid consumed till 24 h after surgery will be recorded) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the total intraoperative opioid consumption  At the time of completion of surgery
 
NRS Scores  At 1, 2, 6 & 24 h after surgery 
Time to first rescue analgesia  The time at which the patient first complains of pain in the postoperative period 
Hemodynamic parameters  0, 1, 2, 6 & 24 h after surgery 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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/ Phase 4 
Date of First Enrollment (India)   21/10/2024 
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  

The sphenopalatine ganglion (SPG) is one of the peripheral parasympathetic ganglia and associated with the general sensory fibres.1  It has been shown that SPG blockade provides postoperative analgesia and reduces the need for analgesics, and it has been claimed to be superior to general anaesthesia alone in nasal surgery.3 After Endoscopic Sinus Surgery performed under general anaesthesia; laryngospasm, nausea-vomiting, headache and sore throat are some of the common complications in the early recovery period. Despite the important developments in analgesia and surgical techniques, there is no consensus on the excessive use of drugs for pain control after Endoscopic Sinus Surgery.The aim of our study is to test the hypothesis that USG guided SPG blockade provides better analgesia in the first 24 h postoperatively than the control group in Endoscopic Sinus Surgery. There is no RCT where USG guided sphenopalatine ganglion blocks has been performed in Endoscopic Sinus Surgery and compared to the group with no block performed.

Primary Objective : To compare the total postoperative opioid consumption up to 24 hours 

Secondary Objective (Optional):
To compare the total intraoperative opioid consumption
NRS scores at 1, 2, 6 and 24 hours postoperatively

Time to first rescue analgesia

Hemodynamic parameters at 0, 2, 6 and 24 hours

Study design: Our study will be a randomized, and double-blind study done on 58 subjects

Inclusion criteria - ASA I and II, 18-60 years of age, surgery lasting less than 3 hrs, male and female of BMI 18-30kg/m2

Exclusion criteria –History of severe liver, renal or cardiovascular disease or chronic pain disease, pre-existing neurological or psychiatric illness, any bleeding abnormality, allergy to the study drug, sensitivity to NSAIDs, hstory of alcohol or drug abuse or chronic use of analgesics, sedatives, opioids, or steroids and pregnant patients

After GA, the intervention group will be administered bilateral SPG block (Group S, n = 29) using USG and 4 mL of 0.5% bupivacaine and 0.5 mcg/kg bodyweight dexmedetomidine in a volume of 1 ml total solution of 5ml to each SPG site will deposited and the control group (Group C, n = 29) will not receive any block. SPG blockade will be performed by an anaesthesiologist who will not be taking part in observation and data collection.  The results will be evaluated by an anaesthesiologist who will not be involved in the study.

SPGB is expected to be effective in postoperative pain control in FESS surgery and provide less exposure to drug side effects by reducing postoperative analgesic consumption. It may reduce the incidence of laryngospasm, nausea and vomiting. 

 
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