| CTRI Number |
CTRI/2018/07/014784 [Registered on: 10/07/2018] Trial Registered Prospectively |
| Last Modified On: |
25/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief in multiple fractured ribs by erector spinae plane block and serratus anterior plane block
|
|
Scientific Title of Study
|
prospective Randomized comparison of erector spinae plane block and serratus anterior plane block in patients with multiple fractured ribs-a pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief consultant and HOD department of anaesthesia and pain relief service |
| Affiliation |
Tata Motors Hospital |
| Address |
Operation Theater Complex, 1st floor, Tata Motors Hospital, Telco colony, Kharangajhar, Jamshedpur-831004
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
65796695676 |
| Fax |
2286318 |
| Email |
ashok.jadon@tatamotors.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief consultant and HOD department of anaesthesia and pain relief service |
| Affiliation |
Tata Motors Hospital |
| Address |
Operation Theater Complex, 1st floor, Tata Motors Hospital, Telco colony, Kharangajhar, Jamshedpur-831004
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
65796695676 |
| Fax |
2286318 |
| Email |
ashok.jadon@tatamotors.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief consultant and HOD department of anaesthesia and pain relief service |
| Affiliation |
Tata Motors Hospital |
| Address |
Operation Theater Complex, 1st floor, Tata Motors Hospital, Telco colony, Kharangajhar, Jamshedpur-831004
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
65796695676 |
| Fax |
2286318 |
| Email |
ashok.jadon@tatamotors.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ashok Jadon |
| Address |
OT complex 1st floor, Tata Motors Hospital, Telco Colony,
Jamshedpur-831004 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Motors Hospital |
Telco colony, Kharangajhar, Jamshedpur-831004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Jadon |
Tata Motors Hospital |
1st floor, OT complex, Tata Motors Hospital, Jamshedpur-831004
Purbi Singhbhum
JHARKHAND |
9234554341
2286318
ashok.jadon@tatamotors.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Motors Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, Patients with unilateral 3 or more than 3 fractured ribs with severe pain which is not controlled by routine analgesic drugs , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block (ESPB) |
Ultrasound guided ESPB with 20 ml of 0.25% bupivacaine. Then a catheter (18G epidural catheter) will be inserted and infusion of 0.1% bupivacaine +Fentanyl 1 mic/ml @6ml/hr will be infused over 5 days. |
| Comparator Agent |
Serratus anterior plane block (SAPB) |
Ultrasound guided SAPB with 20 ml of 0.25% bupivacaine. Then a catheter (18G epidural catheter) will be inserted and infusion of 0.1% bupivacaine +Fentanyl 1 mic/ml @6ml/hr will be infused over 5 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Unilateral 3 or more than 3 fractured ribs with pain
2. Routine oral and systemic drugs for pain management is insufficient
3. No contraindication for catheter based regional analgesia |
|
| ExclusionCriteria |
| Details |
1. Bilateral fractured ribs
2. Severe chest injury which requires ventilator support
3. patients on anticoagulants
4. Allergic to local anesthetics
5.Local site infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients achieved PIC score of 9/10 |
30 minutes, 60 minutes, 120 minutes.Then 8 AM and 8 PM every day for 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Amount of Rescue medicine used.
2. Complications during block.
3. Complication during treatment period
4. Hospital stay
5. satisfaction on discharge |
30 minutes, 60 minutes, 120 minutes.Then 8 AM and 8 PM every day for 5 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/07/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Multiple fractured ribs (MFRs) pain is debilitating and difficult to manage. Opioids were considered mainstay but results in severe side effects. Multi-modal pain management is a current standard practice in which erector spinae plane block (ESPB) and serratus anterior plane block (SAPB) have shown effective role. However, we do not know that which is more efficacious as there is no comparison of these two techniques. Therefore, we wish to conduct a pilot study to compare the relative effectiveness of each technique and safety. We have a plan to do 10 cases with each technique and compare them. All patients will receive ultrasound guided block (ESPB=10 patients, SAPB=10 patients) with 20 ml 0.25% bupivacaine followed by an infusion of 0.1% bupivacaine + fentanyl 1mic/ml @ 6ml/hr through volumeric pump. PIC (Pain -inspiratory capacity-cough) will be assessed and will be compared. The target will be to keep PIC score more than 8/10.The amount of rescue medication will recorded and compared. Any complication during block or during treatment period will also be recorded and compared. |