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CTRI Number  CTRI/2025/04/084004 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the efficacy of nerve block in the face as compared to pain killers given via injection in blood vessel for pain relief in patients undergoing surgery of the maxillary bone 
Scientific Title of Study   USG guided Suprazygomatic Maxillary nerveblock vs parenteral analgesics in patients undergoing maxillary surgeries :Prospective 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  Devalina Goswami  
Designation  Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room no .506, 5th floor, CDER, AIIMS , Ansari Nagar.

South West
DELHI
110029
India 
Phone  9971196699  
Fax    
Email  drdevalinagoswami@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  Devalina Goswami  
Designation  Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anaesthesiology, Pain Medicine and Critical care , Room no 506,5th floor, CDER , AIIMS New delhi

South West
DELHI
110029
India 
Phone  9971196699  
Fax    
Email  devalinagoswami@aiims.edu  
 
Details of Contact Person
Public Query
 
Name  Srujana Suryadevara 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS , Ansari Nagar.

South West
DELHI
110029
India 
Phone  9247424655  
Fax    
Email  sruju99@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, 110029 
 
Primary Sponsor  
Name  Department of Anaesthesiology,Pain Medicine and Critical Care 
Address  room no 5011, teaching block, AIIMS,New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Suryadevara srujana   AIIMS,Ansari Nagar, New Delhi -110029  Department of Anaesthesiology, Pain Medicine and Critical Care, Room no 5011,Academic Block, South Delhi.
South West
DELHI 
9247424655

sruju99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,AIIMS,New Delhi  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 
Comparator Agent  Parenteral analgesics   Parenteral analgesics which include fentanyl and acetaminophen are given intra operatively for pain relief in patients undergoing maxillary surgeries  
Intervention  Suprazygomatic maxillary nerve block   Usg guided suprazygomatic maxillary nerve block is given in patients undergoing maxillary surgeries before the surgical incision.This will be administered after general anesthesia for perioperative analgesia.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients posted exclusively for maxillary
surgeries
2.Patients giving consent
3.ASA PS 1 and 2  
 
ExclusionCriteria 
Details  1.Patients with hemangioma or vascular tumours around the injection site
2.Patients with any local site infection
3.Patients with deranged coagulation profile 4.Patients with decreased IQ or Mental retardation
5.Patients with local anesthetic allergy or contraindication to any of the study drugs
●Patients with difficult anatomy around the injection site (eg :Tmj Ankylosis) 
 
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 
Total amount of intra operative analgesic requirement
( iv fentanyl -mcg/kg)in patients receiving the block compared to controls receiving parenteral analgesics . 
Till the end of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1)Time to first rescue analgesic (iv ketorolac) (mins/hrs)
2) Post operative analgesic requirement (upto 24hrs)
3) Intra operative and post operative hemodynamics
(Heart rate, Mean arterial pressure, Systolic and Diastolic Blood Pressure, Oxygen saturation)
4) Adverse events if any 
Till 24 hours post surgery  
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   25/04/2025 
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)
Modification(s)  
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 - NO
Brief Summary   Title : ’USG GUIDED SUPRAZYGOMATIC MAXILLARY NERVE BLOCK  VS PARENTERAL ANALGESICS FOR INTRAOPERATIVE AND POSTOPERATIVE PAIN RELIEF IN MAXILLARY SURGERY :A PROSPECTIVE RANDOMISED CONTROL TRIAL ’

PRIMARY OBJECTIVES
Total amount of intra operative analgesic requirement ( iv fentanyl -mcg/kg)in patients receiving the block compared to controls receiving parenteral analgesics .

SECONDARY OBJECTIVE
1)Time to first rescue analgesic (iv ketorolac) (mins/hrs)
2) Post operative analgesic requirement (upto 24hrs)
3) Intra operative and post operative hemodynamics(Heart rate, Mean arterial pressure, Systolic and Diastolic Blood Pressure, Oxygen saturation)
4) Adverse events if any

INCLUSION CRITERIA 
●Age -18 to 65 years of age
●Patients posted exclusively for maxillary surgeries
●Patients giving consent
●ASA PS 1 and 2 
 
EXCLUSION CRITERIA 
●Patients with hemangioma or vascular tumours around the injection site 
●Patients with any local site infection
●Patients with deranged coagulation profile 
●Patients with decreased IQ or Mental retardation 
●Patients with local anesthetic allergy or contraindication to any of the study drugs
●Patients with difficult anatomy around the injection site (eg :Tmj Ankylosis)

All the selected patients will undergo a routine pre-anesthetic assessment one day prior to surgery. Patients will also be made familiar with the NRS scoring system. The patient information sheet will be provided to all, and informed written consent from all patients will be obtained. 
Standard fasting guidelines(WHO) will be followed for all patients.
In the operating room, standard monitoring will be done as per Anesthesiologists’(ASA) recommendation (3-Lead ECG, pulse oximetry,NIBP)will be initiated and baseline vitals -Heart rate (HR), systolic BP (BP), diastolic BP (DBP), mean arterial pressure (MAP) will be recorded.An 18G intravenous cannula will be secured preoperatively.Patients will be placed in a supine position with their heads elevated with a pillow approximately 15 degrees.Baseline vitals will be recorded. Preoxygenation will be done with FiO2 100% and flow of 5L/min till the end tidal oxygen fraction is higher than 90% induction with intravenous (IV) Fentanyl 2mcg/Kg, followed by IV Propofol 2mg/Kg will be done followed by nasotracheal intubation with appropriate size endotracheal tube.IV Atracurium at a dose of 0.5mg/Kg will be given as relaxant and timer will be started accordingly. Patients belonging to both groups received standard general anesthesia.
INTERVENTION-
Group C(Control group)- will receive parenteral analgesics ( IV acetaminophen, fentanyl 0.5mcg/kg)
Group I(Intervention group)- will receive by suprazygomatic maxillary nerve block under USG guidance with 
0.25% bupivacaine + clonidine 1mcg/kg and parenteral analgesics (IV acetaminophen, fentanyl0.5 mcg/kg)
During intraoperative period, iv fentanyl will be given as rescue analgesic whenever Heart rate and Systolic Blood Pressure rise more than 20 percent of baseline values , after ensuring adequate muscle relaxation. 

Patients will be maintained with mixture of oxygen and Air(50:50) with isoflurane with a MAC of 0.8-1.0 .
All patients will receive IV dexamethasone as 0.2mg/kg for prevention of intra oral edema which is a standard protocol of our Institute. 
Reversal of anaesthesia (with neostigmine and glycopyrrolate)will be as per standard protocol. 

POSTOPERATIVE PERIOD:
Patients will be managed in the post operative care unit (PACU) where the standard monitoring of oxygen saturation (SpO2), Heart rate (HR) and non invasive blood pressure monitoring will be done every 10 minutes till 2 hours being shifted to ward and postoperative outcomes are simultaneously assessed.

 
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