| CTRI Number |
CTRI/2022/10/046124 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
30/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
Comparison Of ultrasound guided three different nerve group blocks determined by diaphragmatic paresis in patients undergoing arthroscopic shoulder surgery |
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Scientific Title of Study
|
Comparative evaluation of hemidiaphragmatic paresis after Interscalene Brachial Plexus, Anterior Suprascapular And Posterior Suprascapular Nerve Block in patients undergoing arthroscopic shoulder surgery |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankush Mittal |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department Of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
7206746001 |
| Fax |
|
| Email |
ankush221096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Guria |
| Designation |
Associate Professor Anaesthesiology |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department Of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Guria |
| Designation |
Associate Professor Anaesthesiology |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department Of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
|
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Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankush Mittal |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department Of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building
South
DELHI |
7206746001
ankush221096@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anterior suprascapular nerve block |
Group AS will be receiving Anterior suprascapular nerve block. All patients are placed in supine position with head turned to the contralateral side. A linear array ultrasound probe (8–13MHz, M Turbo, Sono Site Inc., USA) is placed in transverse plane on the side of neck to visualize the C5 root of brachial plexus. The probe is moved laterally and suprascapular nerve is identified emerging from the superior trunk. Suprascapular nerve is traced laterally until it lies posteriorly to the omohyoid muscle in the supraclavicular fossa. After the skin infiltration with local anesthetic 1% lignocaine using 25G needle. Thereafter a 22G 100mm short beveled nerve block needle is introduced from the lateral side of probe and 10ml of 0.5% levobupivacaine will be injected slowly after negative aspiration.Diaphragmatic excursion using ultrasound and pulmonary function tests as determined by Forced expiratory volume in first second, Forced vital capacity are measured at preblock, post-block 30minutes and post-operatively 1hr. |
| Comparator Agent |
Interscalene brachial plexus block |
Group IS will be receiving ultrasound guided interscalene brachial plexus block. A linear array ultrasound probe (8–13MHz, M Turbo, Sono Site Inc., USA) will be placed first to obtain an image of sternocleidomastoid and scalene muscle. Followed by identification of brachial plexus nerve as the most hypoechoic nerve structures lying in the groove. C5-C6 roots will be confirmed by tracing and seeing them joining to form the superior trunk of the brachial plexus. After the skin infiltration with local anesthetic 1% lignocaine using 25 G needle, Thereafter a 22 G, 50 mm short beveled nerve block needle will be introduced from the lateral side of the probe to reach between the anterior and middle scalene muscle. Needle tip will be adjusted caudally toward the C6 trunk, 10 ml of 0.5% levobupivacaine will be injected slowly after negative aspiration.Diaphragmatic excursion using ultrasound and pulmonary function tests as determined by Forced expiratory volume in first second, Forced vital capacity are measured at preblock, post-block 30minutes and post-operatively 1hr. |
| Intervention |
Posterior suprascapular nerve block |
Group PS will be receiving Posterior suprascapular nerve block. All patients are in a seated position and linear array ultrasound probe (8–13MHz, M Turbo, Sono Site Inc., USA) is placed parallel to the scapula spine. Transducer is then moved cranially to locate the suprascapular fossa. Supraspinatus muscle is identified and transducer is moved laterally and suprascapular notch is visualized. Suprascapular nerve is identified as a hyperechoeic structure beneath the transverse scapular ligament in the suprascapular notch. After the skin infiltration with local anesthetic 1% lignocaine using 25G needle. Thereafter a 22G 100mm short beveled nerve block needle is introduced with medial to lateral approach and 10ml of 0.5% levobupivacaine will be injected slowly after negative aspiration. Diaphragmatic excursion using ultrasound and pulmonary function tests as determined by Forced expiratory volume in first second, Forced vital capacity are measured at preblock, post-block 30minutes and post-operatively 1hr. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA-I or II physical status scheduled to undergo arthroscopic shoulder surgery. |
|
| ExclusionCriteria |
| Details |
Patients with known case of coagulopathies or on anticoagulant therapy/infection at the proposed site of block/ known allergies to effect of local anesthetics/ Severe Hypertension/ Preexisting Neurological deficit in upper limbs / Preexisting lung diseases or hemidiaphragmatic dysfunction/ Duration of surgery more than 2 hours/ Arthroscopic Rotator cuff repair. |
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of hemidiaphragmatic paresis after ultrasound guided interscalene brachial plexus, anterior suprascapular and posterior suprascapular nerve block as determined by Forced expiratory volume in first second, Forced vital capacity and diaphragmatic excursion |
Pre-block, Post-Block 30 minutes and 1sr hour post-operatively. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To compare analgesic efficacy of interscalene brachial plexus, anterior suprascapular and posterior suprascapular nerve block with regards to 1)Total fentanyl requirements during intraoperative period 2)Numerical rating scale (NRS) pain score 3)Time taken to first rescue analgesia demand 4)Total tramadol consumption during first 24 hours of postoperative period |
Numeric rating pain score at immediate Postop, 1st Hr postop, 6th Hr postop, 12th Hr postop and 24th hour postop. |
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2022 |
| 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="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ankush221096@gmail.com].
- For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
This is a randomized comparative study to compare the incidence of hemidiaphragmatic paresis and analgesic efficacy after Ultrasound guided interscalene brachial plexus, anterior suprascapular and posterior suprascapular nerve block in patients undergoing arthroscopic shoulder surgery under general anaesthesia with the hypothesis that the incidence of hemidiaphragmatic paresis is less after posterior approach of suprascapular nerve block as compared to anterior approach of suprascapular nerve block and interscalene brachial plexus block plexus in patients undergoing arthroscopic shoulder surgery while providing noninferior analgesia. Primarily hemidiaphragmatic paresis is determined by Forced expiratory volume in first second, Forced vital capacity and diaphragmatic excursion at pre-block, post-block 30 minutes and 1st hour post-operatively. Secondarily analgesic efficacy is compared with regards to 1)Total fentanyl requirements during intraoperative period. 2)Numerical rating scale (NRS) pain score. 3)Time taken to first rescue analgesia demand. 4)Total tramadol consumption during first 24 hours of postoperative period. Numerical rating scale (NRS) pain score is measured at immediate post-operatively, 1st hour post-operatively, 6th hour post-operatively, 12th hour post-operatively and 24th hour post-operatively. |