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CTRI Number  CTRI/2024/12/078429 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study to evaluate analgesic effect of injection dexamethasone as an adjuvant with local anesthetic drug bupivacaine and bupivacaine alone in ultrasound guided sphenopalatine ganglion block during and after surgery in patients undergoing head and neck cancer surgery  
Scientific Title of Study   A comparative randomized study to evaluate analgesic effect of dexamethasone as an adjuvant with bupivacaine and bupivacaine alone in ultrasound guided supra-zygomatic sphenopalatine ganglion block perioperatively in patients undergoing elective head and neck cancer surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Archana Gautam 
Designation  Assistant Professor 
Affiliation  Department of Anesthesia Kalyan Singh Super Speciality Cancer Institute 
Address  Kalyan Singh Super Speciality Cancer Institute

Lucknow
UTTAR PRADESH
226002
India 
Phone  09936343627  
Fax    
Email  archana.dolly76@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Archana Gautam 
Designation  Assistant Professor 
Affiliation  Department of Anesthesia Kalyan Singh Super Speciality Cancer Institute 
Address  Kalyan Singh Super Speciality Cancer Institute

Lucknow
UTTAR PRADESH
226002
India 
Phone  09936343627  
Fax    
Email  archana.dolly76@gmail.com  
 
Details of Contact Person
Public Query  
Name  Archana Gautam 
Designation  Assistant Professor 
Affiliation  Department of Anesthesia Kalyan Singh Super Speciality Cancer Institute 
Address  Kalyan Singh Super Speciality Cancer Institute

Lucknow
UTTAR PRADESH
226002
India 
Phone  09936343627  
Fax    
Email  archana.dolly76@gmail.com  
 
Source of Monetary or Material Support  
Kalyan singh super speciality cancer institute, lucknow. 226002 
 
Primary Sponsor  
Name  Kalyan Singh Super Speciality Cancer Institute Lucknow India 
Address  kalyan singh super speciality cancer institute. C.G. City sultanpur road, Lucknow. 226002 
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 Archana  Kalyan Singh Super Speciality Cancer institute   Room no 205 OPD Block Department of Anesthesia
Lucknow
UTTAR PRADESH 		 09936343627

archana.dolly76@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: C021||Malignant neoplasm of border of tongue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Unilateral ultrasound guided sphenopalatine ganglion block  USG images will be obtained with a high-frequency (5-13MHz) linear array probe. The needle will be advanced with an out-of-plane approach and the needle tip can usually be identified, although the out-of-plane imaging of a 22-guage needle is quite subtle. For control group 4 mL of 0.5% bupivacaine combined with 1ml of 0.9% normal saline. The 5-mL injectate will be delivered over 15 to 20 seconds, while the spread of LA will be observed under USG. Time required to perform the technique is defined as the time from the beginning of scanning until the study drug injection and will be recorded.  
Intervention  Unilateral ultrasound guided sphenopalatine ganglion block through suprazygomatic approach  USG images will be obtained with a high-frequency (5-13MHz) linear array probe. The needle will be advanced with an out-of-plane approach and the needle tip can usually be identified, although the out-of-plane imaging of a 22-guage needle is quite subtle. For intervention group cases 4 mL of 0.5% bupivacaine combined with 1ml of dexamethsone injection (4mg/ml). The 5-mL injectate will be delivered over 15 to 20 seconds, while the spread of LA will be observed under USG. Time required to perform the technique is defined as the time from the beginning of scanning until the study drug injection and will be recorded. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA physical status I-II patients, Aged 18–65 years, Patients scheduled for elective head and neck cancer surgery (involving dissection in area of maxilla, palate, retromolar trigone, anterior part of tongue, buccal mucosa) under general anaesthesia.
 
 
ExclusionCriteria 
Details  Patient refusal to participate, Patients who are allergic to local anaesthetics, Patient who require awake fibreoptic intubation, Patients with disfigurement and disturbed anatomy prevented easy access to the sphenopalatine ganglion, Patient who require PMMC flap and or free flap in their management, Those patient who require mechanical ventilation in postoperative stay, Those patients who will be tracheostomized during peri-operative period, History of bleeding disorders, or receiving anticoagulant therapy were excluded, Patients with a history of hepatic, renal, or cardiopulmonary dysfunction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To record the time required by the patient for first rescue analgesia i.e. 75mg diclofenac iv in PACU  At PACU at 30min, 1h, 2h, 6h, 10h, 14h, 18h, 24h and 48 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of intraoperative hemodynamic parameters( HR, MAP, SpO2) at 30 min after induction till extubation of patient
2. Assessment of total perioperative opioid consumption
3. Assessment of postoperative VAS score followed by rescue analgesia consumption at 30min, 1h, 2h, 6h, 10h, 14h, 18h, 24h and 48 hours
4. Assessment SPGB complications like postoperative nausea and vomiting(PONV), visual disturbances, hypoesthesia of root of nose, pharynx, & palate, lacrimation of ipsilateral eye, retro-orbital heamotoma etc. 		 30min, 1h, 2h, 6h, 10h, 14h, 18h, 24h and 48 hours after surgery at PACU 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/01/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [archana.dolly76@gmail.com].

  6. For how long will this data be available start date provided 15-01-2025 and end date provided 15-01-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Inadequate treatment of postoperative pain is common in surgical patients. it has been found that approximately 40% of surgical patients exhibited moderate to severe pain during the first 24 hours postoperatively in a general setting. extensive maxillofacial surgery and patients with cancer may have chronic pain and baseline opioid requirement, making perioperative analgesia management more challenging. Sphenopalatine ganglion blockade is commonly utilized to manage chronic pain syndromes like trigeminal neuralgia, headaches. one the most recently described approaches for SPGB is via ultrasound guided technique. it is a safer technique because maxillary artery is visualised in all cases. we planned our study to evaluate the hypothesis that USG guided supra-zygomatic unilateral SPGB with local anesthesia and adjuvant under general anesthesia could have a longer perioperative analgesia effect, better hemodynamics characteristics, lesser popstoperative nausea and vomiting.  
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