| CTRI Number |
CTRI/2025/10/096588 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPARING TWO AMOUNTS OF PAIN RELIEF MADICATION
IN ANTERIOR SUPRASCAPULAR NERVE BLOCK FOR ARTHROSCOPIC SHOULDER SURGERY |
|
Scientific Title of Study
|
COMPARISON BETWEEN TWO VOLUMES OF 0.5% ROPIVACAINE
IN ANTERIOR SUPRASCAPULAR NERVE BLOCK IN TERMS OF
HEMI-DIAPHRAGMATIC PARESIS AND POST OPERATIVE
ANALGESIA FOR ARTHROSCOPIC SHOULDER 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 |
SHANA PARVEEN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Government Medical College,Kozhikode |
| Address |
Junior resident
Department of Anaesthesiology
Government Medical College, Kozhikode
Kozhikode KERALA 673008 India |
| Phone |
8086537744 |
| Fax |
|
| Email |
shanaparveen666@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K R Radha |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College,Kozhikode |
| Address |
Head Of Department
Professor
Department of Anaesthesiology
Government Medical College, Kozhikode
Kozhikode KERALA 673008 India |
| Phone |
9846228616 |
| Fax |
|
| Email |
kr.radha64@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Fijul Komu |
| Designation |
Professor |
| Affiliation |
Government Medical College,Kozhikode |
| Address |
Professor
Department of Anaesthesiology
Government Medical College, Kozhikode
Kozhikode KERALA 673008 India |
| Phone |
9895660004 |
| Fax |
|
| Email |
fij2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College,Kozhikode |
|
|
Primary Sponsor
|
| Name |
Dr Shana Parveen |
| Address |
Junior Resident
Department of Anaesthesiology, Government Medical College, Kozhikode |
| 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 Shana Parveen |
Government Medical College,Kozhikode |
GOVERNMENT MEDICAL COLLEGE, KOZHIKODE Kozhikode KERALA |
8086537744
shanaparveen666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GOVERNMENT MEDICAL COLLEGE, KOZHIKODE |
Approved |
| Institutional Ethics Committee,Government Medical College,Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex between 18–60 years
American Society of Anaesthesiologists (ASA) physical status I or II
Scheduled for elective unilateral arthroscopic shoulder surgery. |
|
| ExclusionCriteria |
| Details |
Existing chronic pain disorders
Patients with preexisting respiratory disease.
Existing neurologic deficits or neuropathy involving the brachial plexus on the surgical
side.
Contraindication to nerve blocks (infection, bleeding diathesis, allergy to local
anaesthetics)
History of significant psychiatric conditions that may affect patient assessment.
Pregnancy
Complex shoulder arthroscopic surgeries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess diaphragm function following anterior suprascapular nerve block with 6ml
0.5% ropivacaine and 10 ml 0.5% ropivacaine using ultrasonography. |
before the nerve block and 30 minutes after the block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the post operative pain score at 6 hours and 16 hours post operatively using
Numerical Rating Scale. |
6 hours and 16 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
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)
|
10/11/2025 |
| 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
|
This study is a prospective observational study comparing 6 ml and 10 ml of 0.5% Ropivacaine in Anterior Suprascapular nerve block in patients undergoing arthroscopic shoulder surgery. The primary objective of the study is to assess the diaphragm function following the block using ultrasonography and the secondary objective is to assess post operative pain score at 6 hours and 16 hours post operatively using numerical rating scale. Finding a phrenic sparing local anaesthetic volume with adequate post operative analgesia in anterior suprascapular nerve block achieves great relevance in patients with pulmonary compromise undergoing arthroscopic shoulder surgery. Identification of an adequate volume free of respiratory embarrassment as well as providing analgesia is the expected outcome of this study. |