| CTRI Number |
CTRI/2018/02/011651 [Registered on: 01/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Needle tip placement between outside brachial plexus sheath vs inside brachial plexus sheath for ultrasound guided interscalene block; acute pain outcomes and Rates of complications |
|
Scientific Title of Study
|
Hemidiaphragmatic paresis following extrafascial VERSUS conventional intrafascial injection for ultrasound guided interscalene brachial plexus block; A Randomized, Double-Blinded Clinical Study |
| Trial Acronym |
ISBPB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Basvaraja |
| Designation |
Assistant Professor |
| Affiliation |
S Nijalingappa Medical College Navanagar Bagalkot 587102 |
| Address |
C 39 Staff Quarters S Nijalingappa Medical College Navanagar Bagalkot 587102
S Nijalingappa Medical College Navanagar Bagalkot 587102
Bagalkot
KARNATAKA
587102
India |
| Phone |
9886334039 |
| Fax |
|
| Email |
basavarajapothnal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraja |
| Designation |
Assistant Professor |
| Affiliation |
S Nijalingappa Medical College Navanagar Bagalkot 587102 |
| Address |
C 39 Staff Quarters S Nijalingappa Medical College Navanagar Bagalkot 587102
S Nijalingappa Medical College Navanagar Bagalkot 587102
Bagalkot
KARNATAKA
587102
India |
| Phone |
9886334039 |
| Fax |
|
| Email |
basavarajapothnal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraja |
| Designation |
Assistant Professor |
| Affiliation |
S Nijalingappa Medical College Navanagar Bagalkot 587102 |
| Address |
C 39 Staff Quarters S Nijalingappa Medical College Bagalkot 587102
S Nijalingappa Medical College Bagalkot 587102
Bagalkot
KARNATAKA
587102
India |
| Phone |
9886334039 |
| Fax |
|
| Email |
basavarajapothnal@gmail.com |
|
|
Source of Monetary or Material Support
|
| S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL AND RESEARCH CENTER |
|
|
Primary Sponsor
|
| Name |
S Nijalingappa Medical College and HSK Hospital |
| Address |
S Nijalingappa Medical College and HSK Hospital Bagalkot 587102 |
| 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 Basavaraja |
S Nijalingappa Medical College and HSK Hospital |
Department of Anaesthesiology 2nd floor Major OT complex S Nijalingappa Medical College and HSK Hospital
Bagalkot
KARNATAKA |
9886334039
basavarajapothnal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC_Intititional Ethics Committee on Hman Subjects Researc |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, Patients those who undergoing shoulder, hemurus, clavicle, upper arm, forearm surgeries. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Procedure: Comparison OF Intrafascial VS Extrafacial Interscalene Brachial Plexus Block |
Intrafascial Interscalene Brachial Plexus Block with needle tip within Brachial Plexus Sheath with 0.5% Ropivacaine 20ml
Extrafascial Interscalene Brachial Plexus Block needle tip should be 5mm distance from lateral border OF brachial plexus sheath
|
| Intervention |
Procedure; Interscalene Brachial Plexus Block |
Interscalene Brachial Plexus Block with using Ultrasound guidance with 0.5% Ropivacain 20ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-III PHYSICAL STATUS
PATIENTS POSTED FOR SHOULDER AND UPPER ARM SURGERIES UNDER INTERSCALENE BRACHIAL PLEXUS BLOCK |
|
| ExclusionCriteria |
| Details |
Existing neurological deficit in upper limb.
History of neck surgery or radiotherapy.
Moderate to severe pulmonary disease.
Pre-existing chest deformity.
Allergy to amide type local anesthetics.
Coagulopathy.
Infection at site.
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Hemidiaphragmatic paresis assessed with ultrasound |
30 Minute after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rate of success block defined as complete motor sensory block on C5-C6
Functional Respiratory out come using spirometer
Pain Score by VAS Scale
Patint sarisfaction by NRS Scale |
30 Minutes after block |
|
|
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)
|
12/01/2018 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
REFERENCES
Verelst P. et al. in 2013 conducted an evidence-based case management study on respiratory impact of analgesic strategies for shoulder surgery and concluded that a “classic†ISB has near-certain expectation of PNP and might evoke respiratory compromise. Modified approaches at lower level in the neck, using doses of 10 ml or less of diluted concentrations of LAs, limit the risk but cannot reliably avoid it
Palhais N. et al. in 2016 conducted a randomized, controlled, double-blind trial on 40 ASA I-III patients undergoing elective shoulder and clavicle surgery under general anesthesia who received an US-guided ISB using 20 ml 0.5% bupivacaine with epinephrine 1:200000 injected either extrafascial or conventional intrafascial. They concluded extrafascial injection reduces incidence of hemidiaphragmatic paresis and impact on respiratory function while providing similar analgesia |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this randomized control study is Compare the rate of Hemidiaphragmatic paresis Between Extrafascial versus Intrafascial injection for interscalene brachial plexus block and other objectives are Rate of Success of block defined as complete motor sensory block on C5-6, Functional respiratory out come by using spirometer, Pain score will be assessed by VAS Scale, and Patient satisfaction by using NRS rate. |