| CTRI Number |
CTRI/2025/01/078982 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare efficacy of Laryngeal nerve block with, without laryngeal nerve block on throat soarness after Double lumen endotracheal intubation |
|
Scientific Title of Study
|
Comparison of Preoperative ultrasound -guided Internal Branch Block of Superior Laryngeal Nerve with placebo on Postoperative Sore Throat caused by Double Lumen Endotracheal Intubation: A Randomized placebo
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 |
Dr Rishikesh |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Deptt. Of Anaesthesiology Cardiac division, Ward Block , near OT complex, IGIMS Seikhpura Patna
Patna
BIHAR
800014
India |
| Phone |
9734205184 |
| Fax |
|
| Email |
drrishikeshbmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr swati |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Deptt. of Anaesthesiology Ward block , near OT complex, IGIMS Seikhpura Patna
Patna
BIHAR
800014
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishikesh |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Deptt. Of Anaesthesiology , Cardiac division, Ward block, near OT complex,IGIMS Seikhpura Patna
BIHAR
800014
India |
| Phone |
9734205184 |
| Fax |
|
| Email |
drrishikeshbmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of edical Sciences,Department of anaesthesiology, cardiac division Ward Block ,near OT complex, Seikhpura Patna, India - 800014 |
|
|
Primary Sponsor
|
| Name |
Dr Rishikesh |
| Address |
Senior Resident Department of Anaesthesiology
IGIMS, Patna-14 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Alok Kumar Bharti |
Associate Professsor ,Department of Anaesthesiology, IGIMS, Patna-14 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rishikesh |
Indira Gandhi Institute of Medical Sciences |
Department of Anesthesiology, Cardiac division, Ward block, near OT complex, IGIMS Patna
Patna
BIHAR |
9734205184
drrishikeshbmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Use of double lumen endobrochial tube (DLT) |
Group C-No block will performed after DLT intubation |
| Intervention |
Use of double lumen endobronchial tube (DLT) with superior laryngeal nerve block |
Group T- will receive USG guided Internal superior laryngeal nerve block (iSLN) with 2mL(0.2%) ropivacaine after intubation with DLT. Whole procedure will take approxiately half an hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients having age between 18-65 years with either sex, posted for thoracotomy requiring DLT insertion and duration of surgery of 2-3 hours will be performed USG guided internal superior laryngeal nerve block with 2 ml ( 0.2 %) ropivacaine after DLT insertion |
|
| ExclusionCriteria |
| Details |
patient will be excluded fro study are surgery performed in the neck, mouth, or throat area, recent or ongoing upper respiratory infection, and existing preoperative sore throat cases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure incidence of sore throat within 24hrs of surgery |
To measure incidence of sore throat within 24hrs of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)To assess severity of sore throat assessed at study time points (0.5, 2, 6 and 24 h)
b)To assess hemodynamic at regular time points
c)To assess any complication related to block
|
At 0.5 , 2 , 6 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="9"
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
|
A total of 152 patients between 18-65 year of age with either sex posted for thoracic surgery requiring DLT insertion and duration of surgery of 2-3 hours will be randomly allocated into either group T or group C. Group T will receive a USG-guided internal superior laryngeal nerve block with 2 ml ( 0.2%) ropivacaine after Intubation with DLT while Group C will intubated with DLT without block. primary outcome of study will incidence of Post operative sore throat(POST) at 24 hours and secondary outcome will be severity of POST at 0.5 ,2, 6 and 24 hours ,hemodynamics at regular tie point and any associated adverse effect seen with intervention. |