| CTRI Number |
CTRI/2025/09/095447 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two ways of giving nerve block near the back of the nose (Sphenopalatine Ganglion Block – through the nose and through the mouth) for pain relief after sinus surgery
|
|
Scientific Title of Study
|
A Randomized Double-Blind Clinical Trial to Compare the Effectiveness of Intranasal and Transoral Approaches of Sphenopalatine Ganglion Block for Postoperative Analgesia Following Functional Endoscopic Sinus Surgery |
| 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 Yarapotini Sneha Chowdary |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College; Manipal |
| Address |
Department of Anaesthesiology,
1st floor,baliga block, kasturba medical college,
Madhav Nagar,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9985458929 |
| Fax |
|
| Email |
ysneha020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar HD |
| Designation |
Additional Professor and Guide |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology,
1st floor,baliga block, kasturba medical college,
Madhav Nagar,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9008415858 |
| Fax |
|
| Email |
arunhd2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar HD |
| Designation |
Additional Professor and Guide |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology,
1st floor,baliga block, kasturba medical college,
Madhav Nagar,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9008415858 |
| Fax |
|
| Email |
arunhd2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Madhav nagar Manipal- 576104,Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Yarapotini Sneha Chowdary |
| Address |
Depatment of anaesthesiology
1st floor,baliga block kasturba medical college and Hospital,Madhav nagar, Manipal-576104,Karnataka,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 Yarapotini Sneha Chowdary |
Kasturba Hospital,Manipal |
Depatment of anaesthesiology
1st floor baliga,kasturba medical college and Hospital,Madhav nagar, Manipal-576104,Karnataka,India
Udupi
KARNATAKA |
9985458929
ysneha020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intranasal approach of sphenopalatine ganglion block |
drug- 1.5-2ml of 2% Lignocaine+Adrenaline (1:200000) |
| Comparator Agent |
transoral approach of sphenopalatine ganglion block |
drug- 1.5-2ml of 2% Lignocaine+Adrenaline (1:200000) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists Physical Status I and II |
|
| ExclusionCriteria |
| Details |
Localized infection at the site of SPG block application.
Hypersensitivity to local anesthetics.
Patients with chronic pain or long-term opioid use might confound pain assessment.
Coagulopathies or on-going anticoagulant or antiplatelet therapy
Pregnant or breastfeeding patients
Patients with altered mental status or cognitive impairments
Patients with chronic liver/kidney diseases. |
|
|
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 |
| compare the effectiveness of intranasal and transoral SPGB in reducing postoperative pain after functional endoscopic sinus surgery using VAS Score |
6 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
complications associated with intranasal or transoral approaches.
Incidence of postoperative nausea or vomiting |
24 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/10/2025 |
| 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)
|
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
|
All the patients will recieve standard General anesthesia Participants will be randomly assigned to Group I intranasal or Group T transoral using a computer-generated block randomization Allocation will be concealed via sequentially numbered, opaque, sealed envelopes prepared by an independent researcher Transoral Approach - A 24G bent needle is inserted near the second molar, 1.5 to 2 ml of local anesthetic is injected and repeated on the opposite side Intranasal Approach - Cotton pledgets soaked in 2 ml of local anesthetic are inserted along the superior border of middle terminate to reach posterior nasopharyngeal wall where SPG lies. Left for 5 to 10 min for anesthetic absorption and then repeated on the opposite side Following a 10 min wait post block, conventional septoplasty will be performed After extubation, patient will be assessed by a blinded observer for post operative pain using a VAS at intervals 0 min, 30 min, 1 hr, 2 hr, 4 hr and 6 hr. If VAS score is greater than 4, rescue analgesia with IV diclofenac 75 mg will be given Time to 1st rescue analgesia and total post operative analgesia consumption will be recorded. Post operative complications like nausea, vomiting, headache, visual disturbances will be monitored for 24 hr post procedure |