| CTRI Number |
CTRI/2024/11/076323 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare incidence of hemidiaphragmatic parasis in two regional blocks in surgeries of upper limb. |
|
Scientific Title of Study
|
Comparison of Hemidiaphragmatic Paresis after ultrasoundguided Costoclavicular versus Supraclavicular brachial plexus
block in elective upper limb surgeries - A Randomised
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 |
Ajinkya Kalbande |
| Designation |
Junior Resident |
| Affiliation |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
9923054112 |
| Fax |
|
| Email |
ajinkyak31@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Heena Pahuja |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
9823188160 |
| Fax |
|
| Email |
heenapahuja15@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Ajinkya Kalbande |
| Designation |
Junior Resident |
| Affiliation |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
9923054112 |
| Fax |
|
| Email |
ajinkyak31@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Hingna , Nagpur - 440019 |
|
|
Primary Sponsor
|
| Name |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur |
| Type of Sponsor |
Private 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 Ajinkya Kalbande |
NKPSIMS |
NKP Salve Institute of Medical sciences and Research centre and Lata Mangeshkar Hospital, Digdoh hills, Hingna, Nagpur, Anaesthesia department Nagpur MAHARASHTRA |
9923054112
ajinkyak31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nkp salve institute of medical sciences and Research centre and Lata Mangeshkar Hospital institutional ethical committee Digdoh hills, Hingna , Nagpur 440019 |
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 |
Ultrasound Guided Costo-Clavicular Block |
Injection Ropivacaine 0.5% 20ml 10 minutes prior to surgery |
| Comparator Agent |
Ultrasound Guided Supraclavicular Block |
Injection Ropivacaine 0.5% 20ml 10 minutes prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient scheduled for elective upper limb surgery
2. ASA class 1,2,3
3. BMI less than 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Patients unable to cooperate or consent to surgery
2.Preexisting neuropathy
3.Significant pulmonary disease
4.Contralateral phrenic nerve palsy or diaphragmatic dysfunction
5.Allergy to local anaesthetics
6.Infection at needle insertion site |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to
• Diaphragmatic excursion measurement using M-mode during
-Normal breathing,
- Deep breathing and
-Voluntary sniff manoeuvre. |
To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to
• Diaphragmatic excursion measurement using M-mode during
-Normal breathing,
- Deep breathing and
-Voluntary sniff manoeuvre
At intervals of 15 minutes and 30 minutes post block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the block characteristics between ultrasound guided supraclavicular brachial plexus block and ultrasound guided costoclavicular brachial plexus block for elective upper limb surgeries with respect to
1 Block performance time
2 Sensory onset time
3 Motor onset time
4 Total block score |
Patient will be monitored for the above parameters from the time of giving block till 30 mins |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
• Ultrasound-guided supraclavicular (SC) and infraclavicular (IC) approaches have become increasingly common brachial plexus blocks (BPBs) for upper-extremity surgery, because of the greater safety of these methods due to real-time ultrasound guidance and faster onset times.
• The occurrence of hemidiaphragmatic paresis depends on site of injection with the incidence being 45-100% for interscalene brachial plexus block, 28-67% for supraclavicular brachial plexus block and 13-24% for lateral sagittal infraclavicular brachial plexus block.
• Hemidiaphragmatic paresis (HDP) is a frequent complication of the brachial plexus block, caused by unintentional blockade of the phrenic nerve, especially when the block is performed above the clavicle.
• The costoclavicular brachial plexus block (CCB) is a recently introduced infraclavicular approach that targets three cords located lateral to the axillary artery in the costoclavicular space
• The CCB can provide a successful and rapid onset of the blockade with a single injection of a relatively small volume of local anaesthetic.
• The costoclavicular space is considered a retrograde channel to the supraclavicular area, enabling reliable anesthesia, same as supraclavicular block and also there are chances of hemidiaphragmatic paresis. However the incidence of hemidiaphragmatic paresis after costoclavicular block is not clearly known.
• HDP can be easily tolerated in normal patients but it can cause complications in COPD patients. Hence our study to find out incidence of hemidiaphragmatic paresis after CCB will be useful.
• As there are very few studies comparing the hemidiaphragmatic paresis after ultrasound- guided supraclavicular and costoclavicular brachial plexus block in elective upper limb surgeries, we would like to conduct this study comparing the two blocks.
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