| CTRI Number |
CTRI/2026/01/100530 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare changes in diaphragmatic function after USG guided Intermediate cervical plexus bock using 10ml 0.3 percent ropivacaine versus 10ml 0.5 percent ropivacaine in cases of upper limb surgeries under USG guided Supraclavicular brachial plexus block. |
|
Scientific Title of Study
|
A Randomized Comparative study for evaluation of diaphragmatic function after USG guided Intermediate cervical plexus bock 10ml of 0.3 percent versus 10ml of 0.5 percent ropivacaine in cases of upper limb surgeries under USG guided Supraclavicular brachial plexus block at SMS medical college, Jaipur |
| 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 Vandana Mangal |
| Designation |
Senior professor |
| Affiliation |
Sawai Man Singh medical college, Jaipur |
| Address |
Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur.
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Mangal |
| Designation |
Senior professor |
| Affiliation |
Sawai Man Singh medical college, Jaipur |
| Address |
Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur.
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmitha N |
| Designation |
Pg student |
| Affiliation |
Sawai Man Singh medical college, Jaipur |
| Address |
Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9482093916 |
| Fax |
|
| Email |
rashmithanneetpg@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh medical college and hospital |
| Address |
Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur |
| 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 Vandana Mangal |
Sawai Man Singh medical college, Jaipur |
Department of Anesthesiology, Second floor, Dhanwanti Building, JLN Marg, Jaipur Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur
Jaipur
RAJASTHAN |
9829056816
vandanamangal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, SMS Medical college and attached hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S422||Fracture of upper end of humerus, (2) ICD-10 Condition: S423||Fracture of shaft of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10ml 0f 0.5% ropivacaine for intermediate cervical plexus block |
We will evaluate whether USG guided U/L intermediate cervical plexus block with different concentrations of ropivacaine(10ml 0.3% vs 10ml of 0.5%) resulting in different degrees of diaphragmatic dysfunction in upper limb surgeries |
| Comparator Agent |
10ml of 0.3% ropivacaine for intermediate cervical plexus block |
We will evaluate whether USG guided U/L intermediate cervical plexus block with different concentrations of ropivacaine(10ml 0.3% vs 10ml of 0.5%) resulting in different degrees of diaphragmatic dysfunction in upper limb surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing upper limb surgery.
2. Adult patients aged 18-65 years of both sexes.
3. Patients belonging to American Society of Anaesthesiologists (ASA) physical
status I, II and III.
4. Patients giving consent for participation. |
|
| ExclusionCriteria |
| Details |
1. Patient should not be part of any other study.
2. History of allergy to local anaesthetics and Iohexol dye.
3. Patients on anticoagulant therapy and/or history of coagulation disorders.
4. Local infection at the proposed site of intermediate cervical plexus block or
supraclavicular brachial plexus block.
5. Patients with respiratory illness/compromise.
6. Patients with existing sensorineural deficit in the upper limb to be operated.
7. Patients not able to report assessment of block. |
|
|
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 |
Mean change in diaphragmatic excursion and thickness
from the baseline. |
Mean change in diaphragmatic excursion and thickness from the baseline at 40 minutes after ICPB. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Change in diaphragmatic
excursion after SCBP block
2) Change in diaphragmatic
thickness after SCBP block |
1) Change in diaphragmatic
excursion after 40 minutes of SCBP block
2) Change in diaphragmatic
thickness after 40 minutes of SCBP block |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/01/2026 |
| 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="3"
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
|
After obtaining Institutional Ethics Committee approval and written informed consent, 100 patients fulfilling inclusion criteria and exclusion criteria will be included.
In the operation theatre, patient will be identified and received, written and informed consent, PAC, and fasting status will be checked. Routine non-invasive monitors will be attached and vital parameters like pre-operative pulse rate, non-invasive blood pressure, and oxygen saturation will be noted. Peripheral venous access will be established in upper limb with 18G IV cannula and intravenous Ringer Lactate solution will be started.
Patient randomization will be performed using computer generated method.
GROUP A (n= 50): patients will receive 10ml 0.5% ropivacaine in intermediate cervical plexus block with 1ml Iohexol (after test done) dye under the guidance of USG. GROUP B (n= 50): patients will receive 10ml 0.3% ropivacaine in intermediate cervical plexus block with 1ml Ioxehol dye (after test done) under the guidance of USG. Spread of dye will be assessed immediately using image intensifier. Assessment of the diaphragmatic excursion and thickness by ultrasonography will be done at 0, 40 minutes after ICPB. Both the groups will receive 10ml 0.5% ropivacaine under ultrasound guided Supraclavicular brachial plexus block on the same side. Assessment of the diaphragmatic excursion and thickness by ultrasonography will be done at 40 minutes after SCBP block.
After achieving adequate sensory block, surgery will be started.
Intraoperative parameters such as Heart Rate, SBP, DBP, MAP and SpO2 will be monitored according to proforma. At the end of surgery, patients will be shifted to recovery room. |