| 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
|
|
|
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
|
|
|
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
â—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 â—Age -18 to 65 years of age â—Patients posted exclusively for maxillary surgeries â—Patients giving consent â—ASA PS 1 and 2 EXCLUSION CRITERIA â—Patients with hemangioma or vascular tumours around the injection site â—Patients with any local site infection â—Patients with deranged coagulation profile â—Patients with decreased IQ or Mental retardation â—Patients with local anesthetic allergy or contraindication to any of the study drugs â—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.
|