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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  
Name  Address 
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 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  
Status 
Not Applicable 
 
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. 

 
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