| CTRI Number |
CTRI/2025/04/083809 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative efficacy of serratus anterior plane block vs standard care in alleviating pain during chest tube thoracostomy in emergency department |
|
Scientific Title of Study
|
Comparative Efficacy of Serratus Anterior Plane Block vs Standard care in alleviating pain during Chest Tube Thoracostomy in Emergency department: A Randomised control trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudiksha K S |
| Designation |
Junior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency medicine, AIIMS New Delhi , Delhi.
New Delhi
DELHI
110029
India |
| Phone |
7619270599 |
| Fax |
|
| Email |
sudikshabolubail@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parin Lalwani |
| Designation |
Associate professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Anesthesiology, Pain medicine and critical care, AIIMS, NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9650533388 |
| Fax |
|
| Email |
drparinlalwani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parin Lalwani |
| Designation |
Associate professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Anesthesiology, Pain medicine and critical care, AIIMS, NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9650533388 |
| Fax |
|
| Email |
drparinlalwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences, New Delhi , Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
Department of Emergency medicine , AIIMS New Delhi |
| Address |
AIIMS, New Delhi, Delhi 110029 |
| 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 |
| Dr Sudiksha K S |
All india institute of medical sciences,New Delhi |
Department of Emergency medicine, Ansari nagar AIIMS New Delhi 110029
New Delhi
DELHI |
7619270599
sudikshabolubail@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J90||Pleural effusion, not elsewhere classified, (2) ICD-10 Condition: J939||Pneumothorax, unspecified, (3) ICD-10 Condition: J86||Pyothorax, (4) ICD-10 Condition: J940||Chylous effusion, (5) ICD-10 Condition: J942||Hemothorax, (6) ICD-10 Condition: J948||Other specified pleural conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Serratus Anterior Plane Block |
Injection 0.5% Bupivacaine diluted in 0.9% Normal Saline to make it 0.25% solution and 20-30ml of this solution is injected using ultrasound guidance in mid axillary line along 5th rib between latissimus dorsi and Serratus Anterior muscles 20minutes prior to chest tube Thoracostomy. |
| Comparator Agent |
Standard care |
10ml Injection of 2% lignocaine with adrenaline given as local anesthesia at the site of Chest thoracostomy and Injection ketamine 0.25 to 0.5 mg/kg given intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who are 18 years and more with indicatons for chest tube Thoracostomy and willing to give consent. |
|
| ExclusionCriteria |
| Details |
1. Patients allergic to the drugs used in block and local infiltration
2. Infection near the insertion site
3. Cardiac arrest
4. Deranged coagulation parameters
5. Patients needing emergency intercostal drainage tube insertion like tension pneumothorax and patients in severe respiratory distress.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To asses pain using visual analogue scale (VAS) scores during ( 0 hour)and after the procedure at 1 hour , 4 hours and 12 hours
|
To asses pain using visual analogue scale (VAS) scores during ( 0 hour) and after the procedure at 1 hour, 4 hour and 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Ease of doing chest tube Thoracostomy procedure assessed by Physician using likert scale.
2. Total amount of need of rescue analgesia in both arms |
From 1 to 12 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is prospective, open labelled, Randomised control trial of parallel group to compare the efficacy of Serratus Anterior Plane Block versus standard care in alleviating pain during the chest tube thoracostomy procedure in emergency department. Patients with age 18 or more with indicatons for chest tube Thoracostomy and are willing to give consent are enrolled in study after excluding the patients meeting the exclusion criteria. The patients are then Randomised into two different arms based on block randomisation using computer generated sequences and allocation concealment will be done. Primary objective is to assess pain using mean Visual Analogue Scale (VAS) scores during procedure (zero hour), 1 hour, 4 hours,12 hours post procedure in Emergency Department. Secondary objectives are to assess the Ease of doing chest tube thoracostomy procedure assessed by Physician using Likert scale and the total amount of need of rescue analgesia in both the arms. |