| CTRI Number |
CTRI/2025/02/080388 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate hemidiaphragmatic
Paralysis after costoclavicular brachial plexus block through ultrasound |
|
Scientific Title of Study
|
Ultrasonographric evaluation of
Hemidiaphragmatic paralysis following costoclavicular approch to brachial plexus block : A prospective observational study
|
| 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 Naval Jethaliya |
| Designation |
Junior Resident doctor in MD Anesthesiology |
| Affiliation |
Department of Anaesthesia |
| Address |
Department of Anesthesia Lokmanya Tilak Municipal Medical College & sion Hospital ,sion ,mumbai
Mumbai MAHARASHTRA 400022 India |
| Phone |
07588421514 |
| Fax |
|
| Email |
navaljethaliya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devangi Parikh |
| Designation |
Associate Professor , Anesthesiology |
| Affiliation |
Lokmanya Tilak Municipal Medical College & sion Hospital , sion , mumbai |
| Address |
Department of Anesthesia
Mumbai MAHARASHTRA 400022 India |
| Phone |
9820471638 |
| Fax |
|
| Email |
sdevangi10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Devangi Parikh |
| Designation |
Associate Professor , Anesthesiology |
| Affiliation |
Lokmanya Tilak Municipal Medical College & sion Hospital , sion , mumbai |
| Address |
Department of Anesthesia
Mumbai MAHARASHTRA 400022 India |
| Phone |
9820471638 |
| Fax |
|
| Email |
sdevangi10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal medical college & hospital , sion , Mumbai , Maharashtra 400022 |
|
|
Primary Sponsor
|
| Name |
Dr Naval Jethaliya |
| Address |
Department of anesthesia , Lokmanya Tilak Medical College , Sion hospital , Sion , Mumbai Maharashtra 400022 |
| Type of Sponsor |
Other [] |
|
|
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 Naval Jethaliya |
Lokmanya Tilak Municipal Medical College & sion Hospital |
OT complex ,3rd floor, ward building Lokmanya Tilak Municipal Medical College & sion Hospital , sion , mumbai 400022 Mumbai MAHARASHTRA |
7588421514
navaljethaliya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S59||Other and unspecified injuries ofelbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costoclavicular Brachial Plexus Block |
usg guided Costoclavicular Brachial Plexus Block given for the surgeries of arm , forearms .And Diaphragmatic Paralysis observed in patients immediately after Block , 20 min after block & after completion of surgical procedure to detect the incident of diaphragm paralysis |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and above
2. American Society of Anesthesiology (ASA) physical status 1-3
3. Patient scheduled for upper limb (including elbow, forearm, hand and wrist)
surgeries under ultrasound guided CCB
4. Patients with no distal neurovascular deficit |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Infection at the puncture site/ distorted anatomy of the supraclavicular region /
burns
3. Allergic to local anesthetic drugs
4. Significant pulmonary disease in which respiratory compromise can be expected
in case of HDP
5. Coagulopathy, sepsis
6. Pregnant patients
7. Contra-lateral diaphragmatic paralysis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To calculate the incidence of Ipsilateral hemi-diaphragmatic paralysis using
ultrasonography after administration of us guided costoclavicular approach to Brachial
plexus block.
|
immediately after block , 20 min after block & post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Effect of different volumes of local Anesthetic used for costoclavicular brachial
plexus block on hemi-diaphragmatic paralysis
2) Effect of different local anesthetics (Ropivacaine/ Bupivacaine/levobupivacaine)
used for block on diaphragmatic paralysis
3) Operator satisfaction using the two diaphragm assessment techniques |
immediately after block , 20 min after block & post surgery |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
01/03/2025 |
| 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
|
Upper limb surgeries are mainly performed under regional anesthesia as it is cost effective, easy to perform and provides better pain relief as compared to general anesthesia.[1] Brachial plexus provides nerve supply from shoulder to fingertips and it can be performed using various techniques. This includes interscalene block, superior trunk block, supraclavicular, infraclavicular, costoclavicular, lateral infraclavicular and axillary block by various approaches. [2] Hemi diaphragmatic paralysis (HDP) is a frequent complication of the brachial plexus block (BPB), caused by unintentional blockade of the phrenic nerve because of close proximity of brachial plexus and phrenic nerve that supplies diaphragm. Although HDP can reduce forced vital capacity and forced expiratory volume at 1 second but these reductions are generally well tolerated by most patients. HDP, however, can be a serious problem in some patients, including those with underlying lung disease or marginal pulmonary function. As brachial plexus and phrenic nerve move caudally they start to diverge from each other so a higher incidence of HDP is more likely to be associated with interscalene and supraclavicular block as compared to infraclavicular block.[4] The incidence of HDP after infraclavicular brachial plexus block is lower, likely due to the relatively long distance between the phrenic nerve and the block site.[3] Infraclavicular approach to BPB can be provided by traditional approach and the costoclavicular approach.[5] The costoclavicular brachial plexus block (CCB) is a relatively recently introduced (2018) infraclavicular approach that targets three cords located lateral to the axillary artery in the costoclavicular space. Anatomically costoclavicular approach is better than traditional block through lateral infraclavicular P a g e | 24 HDP AFTER COSTOCLAVICULAR BPB DR NAVAL R JETHALIYA approach. In lateral infraclavicular fossa, the cords are located deep to pectoral muscles and separated from each other by the axillary artery[6]. This requires large volume of LA and multiple needle punctures for a successful block, whereas in the costoclavicular fossa cords are located superficially and clustered together[10] so small dose of LA and single needle puncture can provide adequate anesthesia.[9] Moreover, the infraclavicular brachial plexus block alone has limited utility in patients undergoing shoulder surgery because of the poor coverage of the proximal branch, such as the suprascapular nerve. Costoclavicular space is located deep and posterior to middle third of clavicle with subclavius and clavicular head of pectoral muscle anteriorly. Costoclavicular space continues as supraclavicular fossa cranially and medial infraclavicular fossa caudally. The costoclavicular space is considered a retrograde channel to the supraclavicular area, enabling reliable anesthesia, including anesthesia to the suprascapular nerve during shoulder surgery. Because of these anatomical advantages, the CCB is emerging as a promising infraclavicular approach,[11] with several studies showing that the CCB can provide a successful and rapid onset of the blockade with a single injection of a relatively small volume of local anesthetic, with the effect similar to supraclavicular brachial plexus block. However, the costoclavicular space is located proximal to the lateral infraclavicular fossa, providing greater proximity to the phrenic nerve. The CCB may therefore increase the risk of HDP, with one study showing that local anesthetic injected into the costoclavicular space reached the interscalene region, at the level of the superior trunk.[12] Diaphragmatic dysfunction following brachial plexus blockade may be suspected based on clinical signs and symptoms of respiratory compromise. Traditional methods to confirm the diagnosis such as real-time fluoroscopy, pulmonary function testing, or even chest radiography involves radiation exposure, patient transportation, increased cost, are time consuming and can cause discomfort for the patient. Ultra-sonography (US) is an easy, reliable, real time, noninvasive and reproducible P a g e | 25 HDP AFTER COSTOCLAVICULAR BPB DR NAVAL R JETHALIYA alternative method to assess the diaphragm function that can be used at the bedside using standard ultrasound equipment which is readily available in the regional anesthesia block areas. Limited studies have primarily assessed the incidence of HDP following the CCB hence we planned a prospective observational cohort study to |