| CTRI Number |
CTRI/2025/08/092399 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study evaluating two nerve blocks in patients undergoing Functional Endoscopic Sinus Surgeries for assessing pain management pain after surgery. |
|
Scientific Title of Study
|
Comparison of the Efficacy of Ultrasound-Guided Suprazygomatic Maxillary Nerve Block versus Transnasal Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgeries - A Randomized Clinical 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 |
G RANGANAAYAKI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Aarupadai Veedu Medical College and Hospital, Puducherry |
| Address |
Aarupadai veedu medical college and hospital. kirumampakkam. Department of anaesthesiology. Block A
Aarupadai veedu medical college and hospital. kirumampakkam. Department of anaesthesiology. Block A
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9789709095 |
| Fax |
|
| Email |
rangaganesan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G RANGANAAYAKI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Aarupadai Veedu Medical College and Hospital, Puducherry |
| Address |
Aarupadai veedu medical college and hospital. kirumambakkam,cuddalore. Department of Anaesthesiology. Block A
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9789709095 |
| Fax |
|
| Email |
rangaganesan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G RANGANAAYAKI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Aarupadai Veedu Medical College and Hospital, Puducherry |
| Address |
Aarupadai Veedu medical college and hospital. kirumampakkam. cuddalore. Department of Anaesthesiology
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9789709095 |
| Fax |
|
| Email |
rangaganesan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr G Ranganaayaki |
| Address |
Department of Anaesthesiology, Aarupadai Veedu Medical College and hospital, Kirumambakkam, Puducherry-607402, India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr RANGANAAYAKI |
Aarupadai Veedu Medical College and Hospital |
Department of Anaesthesiology, 1st floor, A Block
Pondicherry
PONDICHERRY |
9789709095
rangaganesan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC Institutional Human Ethical Commitee |
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 |
Transnasal Bilateral Sphenopalatine Ganglion Block |
A needle with cotton swab is inserted into nasal cavity till posterior pharyngeal wall and the drug is injected. Duration of the procedure is approximately 10 minutes |
| Intervention |
Ultrasound guided Suprazygomatic Maxillary Nerve Block in Functional Endoscopic Sinus Surgeries. |
A needle is inserted at the suprazgomatic region and directed to the ptergopalatine fossa and the drug is injected. Duration of the procedure is 15 minutes approximately |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ASA II patients undergoing FESS surgeries
BMI less than 30 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with a history of allergy to the drugs used in the study
Infection at puncture site
Neuropathy
Surgeries extending more than 3 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Analgesic efficacy of Ultrasound-Guided Suprazygomatic Maxillary Nerve Block Versus Transnasal Sphenopalatine Ganglion Block in patients undergoing FESS surgeries during Postoperative period, using VAS score. |
Postoperatively at 1,2,4,6,8,10,12 and 24 hours using VAS score. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the ease of block technique in terms of duration
|
Time taken from the start of ultrasound imaging to visualize the landmarks until the time of drug deposition |
| To assess the requirement of rescue analgesia |
onset of first analgesic requirement & total rescue analgesic consumption for 24 hours postoperatively. |
| To assess the patient satisfaction |
Patient satisfaction score will be recorded after 24 hours postoperatively |
| To assess the hemodynamic stability of the patient |
At postoperative period 1,2,4,6,10,12 & 24 hours |
| To assess the postoperative complications such as nausea, vomiting, hematoma & nerve injury |
Postoperative complications will be assessed after 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
28/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - If requested to email, dagta will be shared - rangaganesan@gmail.com
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The leading cause of postoperative pain and discomfort after FESS is the resection of the facial bones around the nasal cavity. The maxillary nerve is the principal nerve supplying the nasal septum, the lateral nasal wall, and the maxillary sinus. The blockade of sensory nerve fibres of the maxillary nerve can relieve postoperative pain in FESS. Sphenopalatine ganglion block (SPGB) in pterygopalatine fossa is known to be a comfortable, efficient and safe method for managing craniofacial pains. The ganglion is made of both sensory and autonomic nerves, with sensory neurons innervating the nasal cavity, palate, and some regions in nasopharynx and oropharynx. SPG block can be performed through transnasal, transoral or transcutaneous approaches. Transnasal SPG block has been frequently used to treat facial pain. The USG- guided suprazygomatic maxillary nerve block (SZMNB) is the easiest approach to the pterygopalatine fossa.This approach avoids penetration of the base of the skull and the orbit. Bony landmarks used are more superficial, more easily palpated, simplifying block performance and improving safety. In this study, We aim to assess the efficacy of ultrasound guided supra-zygomatic maxillary nerve block versus Transnasal Sphenopalatine Ganglion Block for patients undergoing FESS surgeries. |