| CTRI Number |
CTRI/2018/05/013613 [Registered on: 02/05/2018] Trial Registered Prospectively |
| Last Modified On: |
01/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of two different methods of interscalene brachial plexus block that is ultrasound guided and peripheral nerve stimulator guided for hemidiaphragmatic paresis in patients undergoing arthroscopic shoulder surgery. |
|
Scientific Title of Study
|
Comparative evaluation of Hemidiaphragmatic paresis after ultrasound and Peripheral Nerve Stimulator guided Interscalene Brachial plexus block in patients undergoing Arthroscopic shoulder surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishant Mishra |
| Designation |
Post Graduate |
| Affiliation |
Vardhman Mahaveer Medical College And Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive care
Vardhman Mahaveer Medical College and Safdarjung Hospital
New Delhi
South
DELHI
110029
India |
| Phone |
8853208989 |
| Fax |
|
| Email |
nishantmishra821@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Guria |
| Designation |
Senior Specialist and Associate Professor |
| Affiliation |
Vardhman Mahaveer Medical College And Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care
VMMC and Safdarjung hospital
South
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Mishra |
| Designation |
Post Graduate |
| Affiliation |
Vardhman Mahaveer Medical College And Safdarjung Hospital |
| Address |
Department of Anesthesia and IntensivE Care
Vardhman Mahaveer Medical College and Safdarjung hospital
West
DELHI
110029
India |
| Phone |
9871350066 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Intensive Care , Vardhman Mahaveer Medical College and Safdarjung Hospital , New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital
New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nishant Mishra |
Vardman Mahaveer Medical College and Safdarjung Hospital |
Department Of Anesthesia And Intensive Care
South
DELHI |
8853208989
nishantmishra821@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
adult patients (18-65 years) of either sex belonging to American Society of anesthesiology Physical status (ASA) grade I/II scheduled for unilateral arthrocsopic shoulder surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ultrasound guided and peripheral nerve stimualtor guided interscalene brachial plexus block |
ultrasound guided and peripheral nerve stimulator guided interscalene brachial plexus block with 10 ml of 0.5% bupivacain |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiology Physical Status (ASA) grade I/II and scheduled to undergo unilateral arthroscopic shoulder surgery |
|
| ExclusionCriteria |
| Details |
patients with preexisting lung diseases ,hemidiaphragmatic dysfunction , BMI >30 kg /meter2
History of known local anesthetic allergy /neurological deficit in upper limb / coagulopathy / local site infection |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemidiaphragmatic Paresis |
Post Block 30 min , At every hour post operation period till 6th hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
block success rate
duration of post operative analgesia
numerical pain rating scale
incidence of complication |
At the time of Block , During surgery and Post operative periode |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/05/2018 |
| 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" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: A critical
appraisal and review of current techniques. Anaesthesia 2010;65:608-24.
2. Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot
Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg
2015;120:1114-29.
3. Janssen H, Stosch RV, Poschl R, Buttner B, Bauer M, Hinz JM, et al. Blood pressure response
to combined general anaesthesia / interscalene brachial plexus block for outpatient shoulder
arthroscopy. BMC Anesthesiol 2014;14:50.
4. Zoremba M, Kratz T, Dette F, Wulf H, Steinfeldt T, Wiesmann T. Supplemental Interscalene
Blockade to General Anesthesia for Shoulder Arthroscopy: Effects on Fast Track Capability, Analgesic
Quality, and Lung Function. Biomed Res Int 2015; 2015: 325012.
5. Bowens C, Sripada R. Regional Blockade of the Shoulder: Approaches and Outcomes.
Anesthesiol Res Pract. 2012; 2012: 971963.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Prospective randomized interventional comparitive evaluation of hemidiaphragmatic paresis after ultrasound and peripheral nerve stimulator guided interscalene brachial plexus block with 10 ml of 0.5% Bupivacain in ASA Grade I / II patients (18-65 years) of either sex scheduled for unilateral arthroscopic shoulder surgery . |