| CTRI Number |
CTRI/2024/01/061043 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain control after chest injury |
|
Scientific Title of Study
|
INTRAPLEURAL ANALGESIA VS ERECTER SPINAE PLANE BLOCK IN PATIENTS OF BLUNT TRAUMA CHEST - A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
SPICE Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Kumar |
| Designation |
Additional professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 62
Department of General Surgery
AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
705110
India |
| Phone |
9438884253 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
Additional professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 62
Department of General Surgery
AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
705110
India |
| Phone |
9438884253 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aamir Zeshan |
| Designation |
Post Graduate Student |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of General Surgery
AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
705110
India |
| Phone |
9438884253 |
| Fax |
|
| Email |
aamirzeshant7023510931@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science, Bhubaneswar |
| Address |
Sijua, Patrapada, Bhubaneswar, Odisa |
| Type of Sponsor |
Government medical college |
|
|
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 Pankaj Kumar |
All India Institute of Medical Sciences,Bhubaneswar |
Department of General Surgery,
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA |
9438884253
drpkushwaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of medical Sciences, Bhubaneswar |
Approved |
|
|
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 |
| Comparator Agent |
Erector spinae plane catheter block |
Erector spinae plane catheter bolus injection of 15 ml Ropivacine 0.5% eight hourly. |
| Intervention |
Intrapleural infusion of local Anesthetic. |
Inj Ropivacine 0.5%, injected 8 hourly till the ICD removal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All patients with chest trauma and Intercostal chest tube drain in situ |
|
| ExclusionCriteria |
| Details |
-Prior involvement in other studies.
-Known allergy to Ropivacaine or hypersensitivity reaction detected after test dose
-Patients who are suffering from Cardiac and respiratory disorders.
-Patients not able to understand the nature of the study
-Patients with bilateral chest trauma,flail chest,patients needing ventilatory support, surgical intervention(thoracotomy),pre-existing pulmonary disease, associated abdominal/brain/spine injury.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain measured by VAS score |
Pain measured by VAS score 12 hourly till the discharge of patient from hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Total rescue analgesics needed postprocedure.
-Complications post procedure.
-VAS at 30 days post procedure. |
-Measuring the total amount of rescue analgesics in 72 hours post procedure.
-VAS score at 30 days post injury.
-Complications related to the procedures.
-Pulmonary complications upto 30 days.
|
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2024 |
| Date of Study Completion (India) |
29/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
| Comparative research with other forms of regional anesthesia (intercostal block) are scarce. The published articles are plagued with small sample size and unclear methodology. No studies have addressed the issue of persistent pain, a common issue following trauma. The blocks/intrapleural injections have typically not been utilized for longer than 24-48 hours in most studies as well. Erector spinae catheter infusion and intermittent intrapleural Ropivacaine injection were not compared in any studies that we could identify. To compare these two approaches in terms of the incidence of long-term pain after 30 days and the control of acute pain during the first 72 to 96 hours, we propose a study. Incidences of pulmonary problems and complications associated with procedures will also be compared. Primary Objective
ï‚· To compare the analgesic effect (Pain control) of intermittent intrapleural injection of Ropivacaine, with erector spinae catheter continuous infusion of Ropivacaine in blunt trauma chest patients Secondary Objective(s) ï‚· To compare the complications related to both technique ï‚· To assess the long term pain relief & pulmonary complications | |