| CTRI Number |
CTRI/2024/12/077613 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Blocking of internal branch of superior laryngeal nerve using ultrasound before surgery to decrease occurance of sore throat after surgery with face lying downward position spine surgery |
|
Scientific Title of Study
|
Preoperative ultrasound guided internal branch of superior laryngeal nerve block for alleviating postoperative sore throat in prone position surgery: a randomized controlled 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 |
Shubham Sahni |
| Designation |
Junior resident |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Department of Anaesthesia, 4th floor ,A block,Nehru hospital
,PGIMER,Sector 12,madhya marg ,Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7004975206 |
| Fax |
|
| Email |
shubhamsahni41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Suman Arora |
| Designation |
Professor |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Department of Anaesthesia, 4th floor ,A block,Nehru hospital
,PGIMER,Sector 12,madhya marg ,Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316025807 |
| Fax |
|
| Email |
drsumanarora@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Suman Arora |
| Designation |
Professor |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Department of Anaesthesia, 4th floor ,A block,Nehru hospital
,PGIMER,Sector 12,madhya marg ,Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316025807 |
| Fax |
|
| Email |
drsumanarora@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, 4th floor ,A block,Nehru hospital ,PGIMER,Sector 12,madhya marg ,Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER ,CHANDIGARH,INDIA |
| Address |
Department of Anaesthesia, 4th floor ,A block,Nehru hospital ,PGIMER,Sector 12,madhya marg ,Chandigarh, 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shubham Sahni |
PGIMER Chandigarh |
Operation theatre complex,3rd floor,Advanced trauma centre ,PGIMER ,Sector qq12,madhya marg,16002
Chandigarh
CHANDIGARH |
7004975206
shubhamsahni41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Internal branch of superior laryngeal nerve block |
Bilateral (both sides)internal branch of superior laryngeal nerve will be blocked with 2 ml 0.2 % Ropivacaine each injected using 23 g needle under ultrasound guidance out of plane technique after induction in supine position with neck extended,after block patient will be positioned prone and surgery will be proceed.Intraoperative vitals will be recorded and post operatively followed as per protocol |
| Comparator Agent |
Standard general anaesthesia |
No block will be given to these patients .
Patient will be induced similar to intervention group as per protocol ,thereafter will be positioned prone and surgery will be proceeded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Age -18-65 years
2)ASA grades 1 and 2
3)Elective thoracic and lumber spine surgery in the prone position
|
|
| ExclusionCriteria |
| Details |
1.Refusal to consent
2.ASA status III & IV
3.Preoperative hoarseness, sore throat or cough
4.Presence of any predictor of difficult intubation -MMP 3/4
5.Requirement of more than one attempt at endotracheal intubation
6.Patient on corticosteroids
7.Preoperative nasogastric tube in situ
8.Duration of surgery more than 5 hours
9.Allergy to Ropivacaine
|
|
|
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 |
| To assess the incidence of Postoperative sore throat at 6 hours |
6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the incidence of POST at 2 & 24 hrs
To assess the severity of POST at 2, 6 & 24 hrs
Incidence and severity of hoarseness of voice at 2, 6 & 24 hrs
Hemodynamic response to extubation.
Incidence of any other perioperative complications like laryngospasm
Satisfaction score of patient (swallowing discomfort)
|
2,6,24 hours |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
27/12/2024 |
| 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="0"
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
|
Study is designed to evaluate the effectiveness of USG-guided bilateral iSLNB block in alleviating postoperative sore throat in patients undergoing thoracolumber spine surgery in the prone position under general anaesthesia.
|