| CTRI Number |
CTRI/2026/01/101107 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing two types of shoulder nerve blocks to see which less breathing side effects and better pain relief after shoulder arthroscopic surgery. |
|
Scientific Title of Study
|
Comparison of Hemi diaphragmatic Sparing and Analgesic Efficacy of Combined
Infraclavicular and Suprascapular Block Versus Interscalene Block in Arthroscopic Shoulder 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 |
Aishwarya Palanikone Paulpandian |
| Designation |
PG resident |
| Affiliation |
Dr SN Medical College Jodhpur |
| Address |
Department of Anaesthesia and Critical care,Dr SN Medical College,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9047071209 |
| Fax |
|
| Email |
aishwarya3572@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandsana Sharma |
| Designation |
Associate professor |
| Affiliation |
Dr SN Medical College Jodhpur |
| Address |
Department of Anaesthesia and Critical care,Dr SN Medical College,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9460157024 |
| Fax |
|
| Email |
vandana.sh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandsana Sharma |
| Designation |
Associate professor |
| Affiliation |
Dr SN Medical College Jodhpur |
| Address |
Department of Anaesthesia and Critical care,Dr SN Medical College,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9460157024 |
| Fax |
|
| Email |
vandana.sh@gmail.com |
|
|
Source of Monetary or Material Support
|
| MDM Hospital Dr S N medical college Jodhpur Rajasthan 342001 |
|
|
Primary Sponsor
|
| Name |
Dr SN Medical College |
| Address |
Dr SN Medical College,Shastri Nagar,Residency Road ,jodhpur,Rajasthan 342001 |
| 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 |
| Aishwarya Palanikone Paulpandian |
Mathuradas Mathur hospital |
Orthopedics Operation theatre complex, First floor,Dr SN Medical college
Jodhpur
RAJASTHAN |
9047071209
aishwarya3572@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Sampurnanand Medical College Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined infraclavicular and suprascapular nerve block |
Ultrasound guided combined infra clavicular and suprascapular nerve block given preoperatively for athroscopic shoulder surgery as per study protocol and post operative hemidiaphragmatic sparing and analgesic efficacy recorded |
| Comparator Agent |
Interscalene brachial plexus block |
Ultrasound guided Interscalene block will be given preoperatively to patients undergoing arthroscopic shoulder surgery as per study protocol. Postoperative hemidiaphragmatic sparing and analgesic efficacy will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60 years
ASA grade I and II
Patient undergoing elective arthroscopic surgery
|
|
| ExclusionCriteria |
| Details |
patients with pre-existing diaphragmatic paralysis,
severe pulmonary disease,
coagulopathies,
allergy to local anaesthetics,
local site infection
and Patient refusal / not giving consent for undergoing procedure
|
|
|
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 |
| Incidence of hemidiaphragmatic paralysis assessed by ultrasound measurement of diaphragmatic excursion (below 1 to 1.5cm ) |
baseline at preblock ,at 30 minutes ,6 hours and 12 hours post block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare postoperative analgesic efficacy [by pain scores (using NRS), and opioid consumption in 24h].
To assess postoperative pulmonary function changes (FVC ,FEV1)using handheld spirometer.
To evaluate block-related complications.
To assess patient satisfaction (score 1 to 5 )
|
0,6,12,24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
24/01/2026 |
| 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="8"
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
|
Arthroscopic shoulder surgery commonly requires regional anesthesia for analgesia but interscalene block is associated with a high incidence of hemi diaphragmatic paresis and reduction in respiratory function. This randomized controlled trial will compare combined infraclavicular and suprascapular nerve block with interscalene block in adult patients undergoing elective arthroscopic shoulder surgery. After written informed consent, eligible ASA I and II patients will be randomly allocated to receive either ultrasound guided combined infraclavicular plus suprascapular block or ultrasound guided interscalene block before surgery. Diaphragmatic excursion by ultrasound, spirometry values, pain scores at rest and on movement, analgesic consumption and adverse events will be recorded at predefined time points up to twenty four hours postoperatively. The primary objective is to evaluate hemi diaphragmatic sparing, and the secondary objectives are to compare analgesic efficacy, respiratory function and incidence of complications between the two techniques |