| CTRI Number |
CTRI/2025/12/098605 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between two nerve blocking techniques in terms of pain control in key hole shoulder surgeries. |
|
Scientific Title of Study
|
SUBOMOHYOID ANTERTOR
SUPRASCAPULAR BLOCK VERSUS SELECTIVE SUPERIOR TRUNK
BLOCK FOR PERIOPERATIVE ANALGESIA IN 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 |
Anjaly Vattamparambil Remesh |
| Designation |
Junior resident |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology
Government medical college Kozhikode
Kozhikode
P.O 673008
Kozhikode KERALA 673008 India |
| Phone |
8921451632 |
| Fax |
|
| Email |
anjaly543@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. BIJI KP |
| Designation |
Professor (CAP) |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology
Government medical college Kozhikode
Kozhikode
P.O 673008
Kozhikode KERALA 673008 India |
| Phone |
8943162543 |
| Fax |
|
| Email |
bijimchclt@gmail.con |
|
Details of Contact Person Public Query
|
| Name |
Anjaly Vattamparambil Remesh |
| Designation |
Junior resident |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesia
Government medical college Kozhikode
Kozhikode
P.O 673008
Kozhikode KERALA 673008 India |
| Phone |
8921451632 |
| Fax |
|
| Email |
anjaly543@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kozhikode government medical college |
| Address |
Government medical college Kozhikode
pin 673008
|
| 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 ANJALY |
Kozhikode government medical college |
Department of anaesthesiology Kozhikode KERALA |
04952350216
anjaly543@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: M248||Other specific joint derangements,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Elective unilateral arthroscopic shoulder surgery.
2. ASA PS (American Society of Anaesthesiologists -Physical Status) I to II.
3. Age between 18 and 65.
4. BMI 18 – 25 |
|
| ExclusionCriteria |
| Details |
1. Surgeries expected to prolong more than 4 hours
2.severe brinchopulmonary disease, known phrenic nerve palsy
3.existing neurological deficit, chronic pain disorder
4.infection, bleeding disorder, alleegy to local anaesthetic
5. Contraindication to multimodal analgesia
6.Psychiatric illness
7.pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare total analgesics consumption intraoperatively and 24 hours postoperatively.
2. To compare NRS- Numerical Rating Score scores at individual time points (2, 4, 6,
12,18 & 24 hours) postoperatively.
3. To compare the duration of analgesia. |
2 HOURS, 4 HOURS, 6 HOURS, 12 HOURS, 18 HOURS, 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare reduction of diaphragmatic excursion at 30 minutes after block in
centimetres.
2. To compare post block complications.
3. To compare patient satisfaction with analgesia assessed using NRS at 24 hours. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
22/12/2025 |
| 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="2" Months="4" 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
|
This study compares two modern shoulder nerve blocks - Sub omohyoid anterior suprascapular (SSNB) and selective superior trunk block (STB) - to determine which provides better analgesia with fewer side effects for patients undergoing arthroscopic shoulder arthroscopic surgery. Traditional interscalene blocks though effective can cause diaphragmatic palsy and respiratory depression. Newer diaphragm sparing blocks like SSNB and STB may offer similar analgesia with improved safety but direct comparison between them is limited. This prospective observational study will include 64 participants (ASA I-II) undergoing elective unilateral shoulder arthroscopy. Patients will receive either of the blocks using 10 ml of 0.5% bupivacaine along with superficial cervical plexus block. Pain scores, total analgesic consumptions, diaphragmatic movement using USG, complications and patient satisfaction will be assessed. |