| CTRI Number |
CTRI/2020/03/024094 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
07/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of pain relief offered by two different techniques of intramuscular injections in patients who sustained elbow fracture |
|
Scientific Title of Study
|
Comparison of Ultrasound guided infraclavicular brachial plexus block with ultrasound guided periarticular elbow block for post-operative analgesia after elbow surgeries: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Diwan |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Sancheti Hospital |
| Address |
Department of Anaesthesia,
Sancheti Hospital,
11/12 Thube Park, 16, Chhatrapati Shivaji Maharaj Nagar Railway Station Rd, Pune, Maharashtra 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
|
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Diwan |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Sancheti Hospital |
| Address |
Department of Anaesthesia,
Sancheti Hospital,
11/12 Thube Park, 16, Chhatrapati Shivaji Maharaj Nagar Railway Station Rd, Pune
Department of Anaesthesia,
Sancheti Hospital,
11/12 Thube Park, 16, Chhatrapati Shivaji Maharaj Nagar Railway Station Rd, Pune, Maharashtra 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
|
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Diwan |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Sancheti Hospital |
| Address |
Department of Anaesthesia,
Sancheti Hospital,
11/12 Thube Park, 16, Chhatrapati Shivaji Maharaj Nagar Railway Station Rd, Pune, Maharashtra 411005
MAHARASHTRA
411005
India |
| Phone |
|
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti Hospital |
| Address |
11/12 Thube Park, 16, Chhatrapati Shivaji Maharaj Nagar Railway Station Rd, Pune, Maharashtra 411005 |
| 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 |
| Sandeep Diwan |
Sancheti Hospital |
11/12 Thube Park, 16, Chhatrapati Shivaji Maharaj Nagar Railway Station Rd,
Pune
MAHARASHTRA |
9823029328
sdiwan14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraclavicular block |
Patients will receive ultrasound guided brachial plexus block via the infraclavicular approach. |
| Intervention |
Ultrasound guided periarticular elbow plexus block |
Elbow plexus block will be injection of LA in safe zones away from the nerves, in the interfascial planes of muscle surrounding the humerus 5-6cm from the elbow crease. A posterior cutaneous nerve of arm will be injected separately. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Isolated, unilateral elbow fracture |
|
| ExclusionCriteria |
| Details |
Unwilling to participate, multiple fractures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 24 hour fentanyl consumption |
24 hour fentanyl consumption |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative fentanyl used,
Pain scores,
postoperative nausea/vomiting |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/04/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The perioperative analgesia offered by two block i.e. infraclavicular block and periarticular elbow plexus will be compared. Appropriate statistical analysis will be done to find out efficacy of one block over another. |