| CTRI Number |
CTRI/2025/03/083096 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rhomboid Intercostal and Subserratus plane block in patients with multiple rib fracture for pain management |
|
Scientific Title of Study
|
Analgesic efficacy of Rhomboid Intercostal and Subserratus plane block in patients with multiple rib fracture:A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rekha Kumari |
| Designation |
Assistant professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Trauma Surgery and Critical Care
Aiims patna
Patna
BIHAR
801507
India |
| Phone |
7903481143 |
| Fax |
|
| Email |
dr.rekha11636@aiimspatna.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Kumari |
| Designation |
Assistant professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Trauma Surgery and Critical Care
Aiims patna
Patna
BIHAR
801507
India |
| Phone |
7903481143 |
| Fax |
|
| Email |
dr.rekha11636@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha Kumari |
| Designation |
Assistant professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Trauma Surgery and Critical Care
Aiims patna
Patna
BIHAR
801507
India |
| Phone |
7903481143 |
| Fax |
|
| Email |
dr.rekha11636@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| Department of Trauma Surgery and Critical Care
AIIMS Patna
Phwarisharif, India, Pin code-801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical Sciences Patna |
| Address |
Department of trauma surgery and critical care
AIIMS Patna, Phulwarisharif, PIN code-801507 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NA |
NA |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rekha Kumari |
All India Institute of Medical sciences,Patna |
Department of trauma surgery and Critical Care, Trauma Building, 3rd floor OT complex OT No-2
Patna
BIHAR |
7903481143
dr.rekha11636@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J951||Acute pulmonary insufficiency following thoracic surgery, (2) ICD-10 Condition: J709||Respiratory conditions due to unspecified external agent, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 will receive IV patient controlled analgesia with RISS block
|
USG guided RISS block with 20 ml of0.25%bupivacaine will be given.
and Intravenous PCA pump (2mg morphine bolus dose)
Total duration :48 hour
|
| Comparator Agent |
Group 2: will receive only Patient controlled analgesia |
IV PCA Morphine 2 mg Bolus dose with 15 min lock out interval
Total duration : 48 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Rib fracture that induced any respiratory symptoms
History of Trauma not older than one week with multiple, unilateral, or bilateral rib fractures |
|
| ExclusionCriteria |
| Details |
long-standing analgesic therapy
opioids dependence
communication difficulty and any bleeding disorder
hemodynamically unstable
intubated patients
polytrauma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO measure the total morphine consumption in 48 hrs
|
48 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of first rescue analgesia
Hemodyanamic parameter
Adverse effect |
NRS at 30 min,2 hr,4hr,8hr,12hr,then every 6hr until 48hr |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The RISS block may be a good addition to pain control management in multiple Rib fractures as part of multimodal analgesia. It reduces opioid consumption and more Pain relief. RISS block has fewer adverse effects than IV PCA. |