| CTRI Number |
CTRI/2025/08/093758 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of diaphragm function in post-operative period after block in shoulder surgery. |
|
Scientific Title of Study
|
Evaluation of Hemi diaphragmatic paralysis in post-operative period after interscalene block in shoulder arthroscopic patients. |
| 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 Reshma Nath |
| Designation |
Anesthesiologist |
| Affiliation |
Sancheti Institute of Orthopedics and Rehabilitation |
| Address |
Sancheti Institute of orthopedics and Rehabilitation,
Thube park,shivajinagar
Pune
MAHARASHTRA
411005
India |
| Phone |
7447457752 |
| Fax |
|
| Email |
resham.vj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Anesthesiologist |
| Affiliation |
Sancheti Institute of Orthopedics and Rehabilitation |
| Address |
Department of Anesthesiology,
Sancheti Hospital,
Shivaji Nagar,
Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Anesthesiologist |
| Affiliation |
Sancheti Institute of Orthopedics and Rehabilitation |
| Address |
Department of Anesthesiology,
Sancheti Hospital,
Shivaji Nagar,
Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Reshma Nath |
| Address |
Sancheti Institute of orthopedics and Rehabilitation,
Thube park,Shivaji nagar.PIN -411005,Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sandeep Diwan |
Sancheti Hospital,Shivajinagar,Pune,Maharashtra-411005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Reshma Nath |
Sancheti Hospital |
Department of Anaesthesia,JRC wing 6th floor,Thube park,Shivajinagar,PIN-411005
Pune
MAHARASHTRA |
7447457752
resham.vj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M65-M67||Disorders of synovium and tendon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for shoulder arthroscopy for rotator cuff repair between the ages of 18-75 years old,
2. ASA physical status I-III,
3. Mentally competent and able to consent to the study were eligible for enrolment.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of symptomatic hemidiaphragmatic paresis in heterogeneous groups of different volumes and drug concentrations |
2hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate patient discharge time from PACU if affected by HDP.
To evaluate hospital discharge time if affected by HDP.
To assess sleep disturbances if affected by HDP.
|
2hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
08/09/2025 |
| 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="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
|
To investigate the incidence of symptomatic hemidiaphragmatic palsy in post operative period after interscalene block in shoulder arthroscopy patients. To investigate patient discharge time from PACU if affected by HDP To investigate hospital discharge time if affected by HDP To assess any sleep disturbance if affected by HDP |