| CTRI Number |
CTRI/2025/02/081270 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the Effect of 3 different types of nerve blocks - interscalene block,superior trunk block,combined infraclavicular and suprascapular nerve block on regional lung function in patients undergoing shoulder surgery |
|
Scientific Title of Study
|
Comparison of Interscalene Block ,Superior Trunk Block and Combined Infraclavicular and Suprascapular Block on Regional Lung Ventilation in Patients Undergoing Shoulder Surgery - 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 |
Dr Ancy joy |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room No:1027,Department of Anaesthesia AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
6238575123 |
| Fax |
|
| Email |
ancy.joy99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samarjit Dey |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Anaesthesia
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7805920791 |
| Fax |
|
| Email |
drsamarjit@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ancy joy |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room No 1027, Department of Anaesthesia AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
6238575123 |
| Fax |
|
| Email |
ancy.joy99@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Mangalagiri,PIN:522503,GUNTUR ,ANDRA PRADESH, INDIA |
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES ,MANGALAGIRI,GUNTUR PIN:522503,ANDRA PRADESH ,INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 Ancy joy |
AIIMS Mangalagiri |
Room no 1027,Department of Anaesthesia, AIIMS Mangalgiri ,guntur, mangalagiri
Guntur
ANDHRA PRADESH |
6238575123
ancy.joy99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Mangalagiri ,Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blocks given -interscalene block,superior trunk block,combined infraclavicular and suprascapular nerve block |
Blocks given to the patients are randomised and each patient included in the study recieves the block as per the randomisation for a period of 1 year |
| Comparator Agent |
Comparing the effects on regional ventilation in interscalene block,superior trunk block , combined infraclavicular and suprascapular nerve block |
comparing the effect on regional lung ventilation in interscalene , superior trunk and combined infraclavicular and suprascapular nerve block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA 1-2 of age between 18 years to 65 years of both genders are included in this study |
|
| ExclusionCriteria |
| Details |
patient refusal
patients of age less than 18 years and more than 65 years old
ASA PS- 3 and above
pre existing pulmonary disease
previous neck or infraclavicular/suprascapular fossa surgery
BMI more than 30kg/m2
contralateral phrenic nerve palsy
Obstructive Sleep Apnoea |
|
|
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 compare changes in regional lung ventilation and diaphragmatic excursion ratio in interscalene block, superior trunk block and combined infraclavicular brachial and suprascapular nerve block |
T0-baseline
T1-1 hour after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of hemi diaphragmatic palsy
To determine the correlation between regional lung ventilation and diaphragmatic excursion ratio
To compare numerical rating score on pain among these nerve blocks |
T0- baseline
T1- 1 hour after surgery |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="11"
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
|
Regional anaesthesia has an established role in providing perioperative analgesia for shoulder surgeries. Interscalene block is considered as the gold standard analgesia ,but it holds a high risk of involving phrenic nerve (100%) and thereby hemi diaphragmatic palsy. It can increase morbidity in patients with pre existing respiratory diseases. Several alternatives to the Interscalene block have been proposed in order to avoid the effect on the diaphragm function ,which include Superior Trunk block, Combined Infraclavicular and Suprascapular Nerve block . The phrenic nerve lies in close proximity to the brachial plexus and diverge as it descends over the anterior scalene muscle and as it approaches the root of the neck ,the phrenic nerve usually lies between the subclavian artery and vein , before coursing medially in front of the Internal thoracic artery . Incidence of phrenic nerve involvement in Superior Trunk block and Combined Infraclavicular and Suprascapular Nerve block ranges between 25 - 76.3% and 6 % respectively. Even though the involvement of phrenic nerve is studied, its influence on respiratory parameters such as regional lung ventilation is not studied much in any other studies conducted before about these blocks. Electrical Impedence Tomograph is one of the recent lung imaging technique that can provide dynamic information on distribution of regional lung ventilation . EIT possess high temporal and functional resolution allowing the visualisation of dynamic physiological and pathological changes on a breath to breath basis. EIT detect changes in electrical impedence (i.e changes in gas/fluid ratio ) and describes them in real time, both visually through images and waveforms and numerically allowing the clinician to monitor the disease evolution .In this we are comparing the effect of Interscalene block, Superior Trunk block and Combined Infraclavicular Brachial and Suprascapular nerve block on regional lung ventilation by using Electrical Impedence Tomograph. |