| CTRI Number |
CTRI/2025/06/089807 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare ultrasound-guided and transnasal sphenopalatine ganglion block for reducing pain after brain surgery in adults |
|
Scientific Title of Study
|
Effect of ultrasound guided bilateral sphenopalatine ganglion block versus transnasal bilateral sphenopalatine ganglion block on postcraniotomy pain in adult patients undergoing supratentorial craniotomies: a prospective randomised controlled study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chetan kumar |
| Designation |
First Year Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesiology, Operation theatre complex,1st floor, IPD building, All India Institute of Medical Sciences Bathinda, Bathinda, Punjab, India
Bathinda
PUNJAB
151001
India |
| Phone |
9988866777 |
| Fax |
|
| Email |
ankuarora99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navneh Samagh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Room no 139, Department of Anaesthesiology, Operation theatre complex,1st floor, IPD building, All India Institute of Medical Sciences Bathinda, Bathinda, Punjab, India
Bathinda
PUNJAB
151001
India |
| Phone |
8427264480 |
| Fax |
|
| Email |
navnehsamagh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navneh Samagh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Room no 139, Department of Anaesthesiology, Operation theatre complex,1st floor, IPD building, All India Institute of Medical Sciences Bathinda, Bathinda, Punjab, India
Bathinda
PUNJAB
151001
India |
| Phone |
8427264480 |
| Fax |
|
| Email |
navnehsamagh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Chetan Kumar |
All India Institute of Medical Sciences Bathinda |
Department of Anaesthesiology, Operation theatre complex, 1st floor, IPD building
Bathinda
PUNJAB |
9988866777
ankuarora99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS BATHINDA |
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 sphenopalatine ganglion block |
The procedure will be performed by using a transnasal approach with hollow cotton swabs. Patients will be positioned supine with their necks extended and nostrils directed upward. Two hollow cotton swabs, soaked in 0.5% bupivacaine, will be inserted into each nostril, following the superior edge of the middle concha to reach the posterior nasopharyngeal wall. Following insertion, an intravenous catheter will be placed within each hollow swab to provide 4.5 cc of the study drug. About 0.5 cc of medication will be absorbed by each soaked swab, for a total of roughly 5 cc of 0.5% bupivacaine given per nostril. The swabs will remain in place for 10 minutes before being removed. |
| Intervention |
Ultrasound guided sphenopalatine ganglion block |
The procedure will be performed by using ultrasound guidance (Sonosite Fujifilm Edge II Inc, USA). An ultrasound-visible stimulation needle will be inserted approximately 1 to 1.5 cm above the zygomatic arch and behind the posterior orbital rim. The needle will be introduced perpendicular to the skin and advanced about 20 mm deep to reach the greater wing of the sphenoid bone. Subsequently, the needle will be redirected through the pterygomaxillary fissure into the pterygopalatine fossa. A high-frequency linear array probe will be used for ultrasound imaging. It will be placed over the maxilla, in the infrazygomatic region, and at an angle of around 45 degrees cephalad. The pterygopalatine fissure, which is bounded anteriorly by the maxilla and posteriorly by the ultrasonic shadow of the mandibular coronoid process covering the larger wing of the sphenoid, will be seen with this positioning. The needle will be advanced using an out-of-plane technique. Before injecting, negative aspiration for blood will be confirmed to avoid accidental intravascular placement. Each patient will receive 5 ml of 0.5% Bupivacaine, administered over 15 to 20 seconds, with careful ultrasound monitoring to observe the local anaesthetic spread. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients above 18 years of age of either gender. 2) American Society of Anaesthesiologists physical status I and II patients scheduled for elective craniotomy for supratentorial space-occupying lesions under general anesthesia
3) Pre-operative Glasgow Coma Scale 15 |
|
| ExclusionCriteria |
| Details |
1) Patients not giving consent.
2) Patients who are allergic to any study drug.
3) Patient with bleeding diathesis.
4) Patient with a history of facial trauma.
5) Any systemic or local infection.
6) Patients not extubated immediately after surgery
7) History of nasal trauma, nasal bleed, nasal infection, nasal deformity
8) Neurosurgeries requiring pin application |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain will be assessed at 6, 12, 24, and 48 hours using the Numerical Rating Scale (NRS) |
Postoperatively at 6, 12, 24, and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative hemodynamic parameters (Heart rate, Systolic Blood pressure, Diastolic Blood pressure, Mean Arterial Pressure, SpO2) |
0 minutes (baseline before incision),
15 minutes,
30 minutes,
45 minutes,
60 minutes |
| Total post-operative analgesic consumption in 48 hours |
48 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
09/08/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
This prospective randomized controlled trial is designed to compare the analgesic efficacy of ultrasound-guided bilateral sphenopalatine ganglion (SPG) block versus transnasal bilateral SPG block in adult patients undergoing supratentorial craniotomies. The primary objective is to evaluate postoperative pain using the Numeric Rating Scale (NRS). The study hypothesis is that ultrasound-guided SPG block provides superior postoperative analgesia compared to the transnasal technique. Secondary outcomes include time to first rescue analgesia and total analgesic consumption. The study is to be conducted at AIIMS Bathinda. |