CTRI

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CTRI Number

CTRI/2026/02/103825 [Registered on: 13/02/2026] Trial Registered Prospectively

Last Modified On:

13/02/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A Study Comparing Two Methods of Numbing a Nerve During Sinus Surgery

Scientific Title of Study

Comparative Evaluation of efficacy of Ultrasound guided versus Landmark technique of Sphenopalatine ganglion nerve block in patients undergoing Functional Endoscopic Sinus Surgery: A Randomized, Open -label, Superiority Trial

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ridhima Sharma
Designation	Associate Professor
Affiliation	AIIMS Nagpur
Address	Department of Anaesthesiology, First floor IPD Building, AIIMS nagpur OT complex , first floor, Departmnet of Anaesthesia , AIIMS, Nagpur Nagpur MAHARASHTRA 441108 India
Phone	8054549458
Fax
Email	drridhimasharma@yahoo.com

Details of Contact Person
Scientific Query

Name	Ridhima Sharma
Designation	Associate Professor
Affiliation	AIIMS Nagpur
Address	OT complex , first floor, Departmnet of Anaesthesia , AIIMS, Nagpur OT complex , first floor, Departmnet of Anaesthesia , AIIMS, Nagpur Nagpur MAHARASHTRA 441108 India
Phone	8054549458
Fax
Email	drridhimasharma@yahoo.com

Details of Contact Person
Public Query

Name	Ridhima Sharma
Designation	Associate Professor
Affiliation	AIIMS Nagpur
Address	OT complex , first floor, Departmnet of Anaesthesia , AIIMS, Nagpur OT complex , first floor, Departmnet of Anaesthesia , AIIMS, Nagpur Nagpur MAHARASHTRA 441108 India
Phone	8054549458
Fax
Email	drridhimasharma@yahoo.com

Source of Monetary or Material Support

AIIMS Nagpur

Primary Sponsor

Name	AIIMS Nagpur
Address	MIHAN, Nagpur, Maharashtra
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 Ridhima Sharma	AIIMS Nagpur	Department of Anaesthesiology, first floor IPD building, AIIMS Nagpur Nagpur MAHARASHTRA	9004598302 dridhimasharma@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIMS Nagpur	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	Landmark guided sphenopalatine block	Participants randomized to the comparator group will receive a landmark-guided, transnasal sphenopalatine ganglion block performed by the ENT surgeon. A cotton applicator soaked with 2 ml of 0.5% bupivacaine will be inserted transnasally and positioned in the posterior nasal cavity, posterior to the inferior turbinate, targeting the region overlying the sphenopalatine ganglion. The applicator will be left in situ for an adequate duration to allow passive diffusion of the local anaesthetic to the ganglion.
Intervention	USG guided sphenopalatine block	Participants randomized to the intervention group will receive an ultrasound-guided sphenopalatine ganglion (SPG) block prior to functional endoscopic sinus surgery. A high-frequency linear ultrasound probe will be used to identify the pterygopalatine fossa via a lateral infratemporal approach. The block will be performed using an out-of-plane needle insertion technique under real-time ultrasound guidance. After negative aspiration, 2 ml of 0.5% bupivacaine will be deposited within the pterygopalatine fossa under direct visualization to ensure accurate drug delivery and minimize complications.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1. Patients aged 18 to 50 years 2. American Society of Anesthesiologists physical status I or II

ExclusionCriteria

Details

1. Patients aged less than 18 years and more than 50yeras
2. Emergency surgeries
3. Patient not willing to participate.
4. Patients with infective pathologies eg mucormycosis.
5. Patients with cardiac disorders.
6. History of allergy to medications being used.

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
Comparison of intraoperative haemodynamic stability between trans-nasal and ultrasound-guided SPG block techniques, assessed by heart rate (HR) and mean arterial pressure (MAP) measured at predefined intervals throughout surgery	Every 15 min throughout the surgery and upto 2 hrs postoperatively

Secondary Outcome

Outcome

TimePoints

Secondary Outcomes:Total intraoperative opioid consumption in both groups.
Requirement of additional agents (dexmedetomidine) for achieving permissive hypotension during surgery. Quality of the surgical field, assessed using the surgeon-rated Surgical Field Rating (SFR) scale.
Block performance time in the ultrasound-guided group (Group U).
Postoperative pain scores assessed using the VAS at predefined intervals (0, 2, 6, 12 & 24 hours).
Incidence of postoperative complications within 24 hours, including headache, visual disturbances, nausea, vomiting, sore throat, & swallowing difficulty.

At 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 4

Date of First Enrollment (India)

27/02/2026

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="6"
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

This prospective, randomized, single-blinded superiority trial will compare the efficacy of ultrasound-guided versus traditional trans-nasal sphenopalatine ganglion block (SPGB) in adult patients undergoing Functional Endoscopic Sinus Surgery (FESS) at AIIMS Nagpur. Postoperative pain and haemodynamic instability remain major concerns in FESS, and SPG block is an emerging technique to improve perioperative analgesia. While the trans-nasal method is simple but variable, ultrasound guidance may offer more accurate drug deposition with improved safety and efficacy.

A total of 60 patients, aged 18–50 years with ASA I–II status, will be randomly allocated into two equal groups: Group N (trans-nasal SPGB) and Group U (ultrasound-guided SPGB). All patients will undergo standardized general anaesthesia. Group N will receive a cotton-swab–based bupivacaine application, while Group U will receive a targeted injection under ultrasound visualization.

The primary outcome is intraoperative haemodynamic stability measured through heart rate and mean arterial pressure. Secondary outcomes include total intraoperative opioid requirement, need for dexmedetomidine for controlled hypotension, surgical field quality, block performance time, postoperative VAS scores, and complications within 24 hours.

Data will be analysed using appropriate parametric or non-parametric tests, with significance set at p<0.05. The study aims to generate evidence to guide optimal SPGB technique for improved perioperative outcomes in FESS.