| CTRI Number |
CTRI/2025/05/086831 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare Two Types of Pain Relief Methods for People Getting a Chest Tube |
|
Scientific Title of Study
|
Serratus Plane Block Versus Local Anesthesia Infiltration in Patients Undergoing Intercostal Drain Insertion: A Randomized 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 |
Sarath S Nair |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Emergency Medicine, AIIMS Rishikesh, virbhadra Road, Rishikesh, Uttarakhand
Dehradun UTTARANCHAL 249203 India |
| Phone |
7907069783 |
| Fax |
|
| Email |
sarathsajeevnair166@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Poonam Arora |
| Designation |
Associate professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Emergency Medicine, AIIMS Rishikesh, virbhadra Road, Rishikesh, Uttarakhand
Dehradun UTTARANCHAL 249203 India |
| Phone |
84477987835 |
| Fax |
|
| Email |
poonam.em@aiimsrishikesh.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Sarath S Nair |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Emergency Medicine, AIIMS Rishikesh, virbhadra Road, Rishikesh, Uttarakhand
UTTARANCHAL 249203 India |
| Phone |
7907069783 |
| Fax |
|
| Email |
sarathsajeevnair166@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS , Rishikesh, virbhadra road , rishikesh,dehradun district , uttarakhand , India
PIN: 249203 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, virbhadhra road , rishikesh, uttarakhand 249203 |
| 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 Sarath s nair |
AIIMS RISHIKESH |
Department of Emergency Medicine , Level 1 , C Block Dehradun UTTARANCHAL |
7907069783
sarathsajeevnair166@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
local anesthesia infiltration |
0.5 % ropivacaine is administered from the skin at the level of the 6th rib and intercostal space, then into the subcutaneous tissue along the tract to the 4th or 5th intercostal space, into the intercostal muscle and the pleura. Aspiration of air or fluid indicates that the needle has entered the pleural space. The remainder of the anesthetic is then infused into the pleural space.The procedure can be finished within 5 minutes |
| Intervention |
seratus plane block |
: For the SPB group, a 9 to 13.0 MHz high-frequency linear array ultrasonic probe encased in sterile isolation film will be placed longitudinally on the chest wall at the fifth rib in the mid axillary line for scanning. The probe was fixed after positioning to display latissimus dorsi, serratus anterior , and intercostal muscles, and a 22-gauge (80-mm) nerve block needle was inserted in the fifth intercostal space along the plane superior to the serratus anterior muscle. After withdrawing the plunger to check for blood and air, a 2-ml tracer was injected to confirm the position of the needle tip, followed by injection of 20 ml 0.5% ropivacaine. The procedure takes approximately around 5-10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are 18 yrs or more who gives consent and having indication for an intercostal drainage insertion |
|
| ExclusionCriteria |
| Details |
Patients who are in altered mental status
Patients having history of local anesthetic allergy
Patients with infection at the insertion site
Patients with deranged bleeding parameters
Patients those who need emergency inter costal drainage tube insertion like tension pneumothorax and patients in severe Respiratory distress
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients will be asked to score their average pain on a Numeric Pain Rating Scale 10 mm from 0-10 mm where 0 suggests no pain and 10 suggests extreme pain at 4th hr. |
4th hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. NRS score
|
8th and 12 th hr |
|
|
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)
|
18/05/2025 |
| 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="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
|
A life-saving technique known as chest
tube thoracostomy (CTT) facilitates lung re expansion, avoids tension
pneumothorax, aids in the healing process following surgery, and relieves symptoms
in some types of cancer(1,2).Pneumothorax, hemothorax, chylothorax, empyema,
penetrating or severe blunt chest trauma, symptomatic pleural effusion, and
chemical pleurodesis for benign and malignant disorders are among the
circumstances for which CTT is indicated(3,4,5).But CTT is an extremely painful
technique, with over 50% of patients reporting significant pain during or
following the surgery(6).The location of the surgical incision, injury to the
intercostal nerve, the pleural incision, or the presence of the drainage tubes
and the irritation they cause afterwards can all cause pain.
TT is inserted following a regional
anesthetic approach. Epidural, paravertebral, muscular plain,
intraspinal, intercostal nerve blockage (ICNB), cryo analgaesia,
and local administration of anesthetic agents are of presented regional
anesthesia for TT insertion .Of these local infiltration anesthesia (LIA)
is typically used, either with or without conscious sedation(7,8,9).Although
local infiltration is normally safe, its effectiveness is short-lived(10)
A new method to manage patients undergoing
CTT’s pain both during and after surgery is fascial plane block (also known as
serratus anterior plane block [SPB]). In addition to being useful for treating
rib fracture pain and situations requiring the insertion of a chest tube due to
anterior and lateral chest wall injuries, SPB was originally developed to give
analgesia during breast surgery .It has been demonstrated that SPB is a rather
long-lasting localized anesthetic, which enhances incentive spirometry volumes
and pain scores(11,12).
While most of the studies are done in a
controlled settings like operation theater
this study will compare the SPB and LIA for post procedural analgesia in
emergency department where pain management become a key role in managing these
patients. |