| CTRI Number |
CTRI/2022/02/040120 [Registered on: 08/02/2022] Trial Registered Prospectively |
| Last Modified On: |
27/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness of two group of nerve blocks in patients undergoing upper arm and shoulder orthopaedic surgeries. |
|
Scientific Title of Study
|
A Prospective randomized study comparing the effectiveness of Ultrasound guided Costoclavicular and Suprascapular nerve block with Interscalene block in patients undergoing upper arm and shoulder orthopaedic surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eva Sharma |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College,Shimla |
| Address |
Department of Anaesthesiology,IGMCH Shimla Shimla Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8219021242 |
| Fax |
|
| Email |
evasharma130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Kaushal |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College,Shimla |
| Address |
Department of Anaesthesiology,IGMCH Shimla Shimla Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9888359167 |
| Fax |
|
| Email |
sonalikaushal33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Kaushal |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College,Shimla |
| Address |
Department of Anaesthesiology,IGMCH Shimla Shimla Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9888359167 |
| Fax |
|
| Email |
sonalikaushal33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, IGMCH Shimla,Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Eva Sharma |
| Address |
Junior Resident, Department of Anesthesiology,IGMCH,Shimla, Himachal Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Eva Sharma |
Indira Gandhi Medical College, Shimla,H.P. |
Room no. 501 , Division B, Department of Anesthesiology Indira Gandhi Medical College,Shimla Himachal Pradesh
Shimla
HIMACHAL PRADESH |
8219021242
evasharma130@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional ethics committee IGMC Shimla |
Approved |
|
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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 |
Costoclavicular and Suprascapular block |
Under ultrasound guidance 22G needle will be advanced in the middle of the three cords of brachial plexus in the costoclavicular space using in plane technique. 18ml of 0.5% ropivacaine + 1mcg/kg dexmedetomidine will be injected.
Another 22G needle will be inserted underneath the omohyoid muscle at the supraclavicular fossa and 7ml of 0.5% ropivacaine+1mcg/kg dexmedetomidine is injected. The patient will be followed up till 24 hours after the surgery.
|
| Intervention |
Interscalene block |
Using ultrasound guidance 22G needle will be inserted using in-plane technique within the interscalene groove in between the anterior and middle scalene muscles and 25ml of 0.5% ropivacaine with 1mcg/kg of dexmedetomidine will be given. The patient will be followed up till 24 hours after the surgery. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients in the age group of 18 to 65 years with physical status ASA I and ASA II. |
|
| ExclusionCriteria |
| Details |
1. ASA III,IV,V patients 2. Patients with coagulation abnormalities 3. Pregnant patients 4. Patients with known hypersensitivity to local anaesthetics 5. Uncooperative and unwilling patients 6. Morbid obese patients 7. Patients suffering from peripheral neuropathy or any demylienating disorders |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the difference in time of onset and duration of sensory blockade between the two groups.
2.To compare the difference in time of onset and duration of motor blockade between the two groups. |
Sensory block 0min
5min
7min
10min
20min
Motor block 0min
5min
7min
10min
2omin |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2022 |
| 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
|
NIL |
|
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-identiļ¬cation.
- 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 who provide a methodologically sound proposal.
- 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 [evasharma130@gmail.com].
- For how long will this data be available start date provided 13-01-2023 and end date provided 13-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title of the project - "A Prospective randomised study comparing the effectiveness of ultrasound guided costoclavicular + suprascapular nerve block with interscalene block in patients undergoing upper arm and shoulder orthopaedic surgeries." Objectives of the study: Primary objectives: 1. To compare the difference in the time of onset and duration of sensory blockade between the two groups. 2. To compare the difference in time of onset and duration of motor blockade between the two groups. Secondary objectives: 1. To compare analgesic consumption intraoperatively and postoperatively in the first 24 hours between the two groups. 2. To compare intra and postoperative hemodynamic changes if any. 3. To assess and compare patient satisfaction score after the surgery between the two groups. 4. To compare complications and adverse effects if any, between these two block techniques. 5. To compare incidence of failure rate between the two groups.
As according to the previous studies, costoclavicular block is safe in patients with pneumothorax and costoclavicular block when combined with suprascapular nerve block will result in more complete anaesthetic coverage of the shoulder joint . While interscalene block is often associated with hemi diaphragmatic paresis due to close proximity of phrenic nerve. However, limited studies are available that compare the effectiveness of combined costoclavicular and suprascapular brachial plexus block with interscalene block in upper arm and shoulder orthopaedic surgeries. Hence we decided to compare these ultrasound guided nerve blocks in terms of efficacy and quality of block, requirement of intra operative analgesia and post-operative analgesia and patient satisfaction score in patients undergoing upper arm and shoulder orthopaedic surgeries.
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