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CTRI Number  CTRI/2025/02/081066 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Is Intertransverse plane block better than Erector spinae plane block in rib fractures 
Scientific Title of Study   Comparative Efficacy of Ultrasound guided intertransverse plane ITP block with Erector Spinae Plane ESP block on pain scores in unilateral multiple rib fractures A prospective randomized control 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 Amrita Rath 
Designation  Associate Professor 
Affiliation  Institute Of Medical Sciences, Banaras Hindu University 
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu university , Pandit Madan Mohan Malaviya road, Kabir colony, Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  7379140545  
Fax    
Email  amritar@bhu.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amrita Rath 
Designation  Associate Professor 
Affiliation  Institute Of Medical Sciences, Banaras Hindu University 
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu university , Pandit Madan Mohan Malaviya road, Kabir colony, Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  7379140545  
Fax    
Email  amritar@bhu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gautham R 
Designation  Junior Resident 
Affiliation  Institute of medical sciences, Banaras Hindu university 
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi. Uttar Pradesh Varanasi UTTAR PRADESH

Varanasi
UTTAR PRADESH
221005
India 
Phone  9344220878  
Fax    
Email  gautham977@gmail.com  
 
Source of Monetary or Material Support  
Material support only by IMS BHU. Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi. Uttar Pradesh 221005 
 
Primary Sponsor  
Name  Institute of medical sciences 
Address  Institute of medical sciences, Banaras Hindu university. Varanasi 221005 
Type of Sponsor  Research institution and hospital 
 
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 Amrita Rath  Institute of medical sciences, Banaras Hindu university  Department of Anaesthesiology office, 1st floor, Sir Sunderlal hospital, Banaras Hindu University, Pandit Madan Mohan Malaviya Road, Kabir colony, Varanasi. Uttar Pradesh Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH 
7379140545

amritar@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE VARANASI 221005  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S224||Multiple fractures of ribs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector Spinae plane block  Patients with rib fractures presenting to the triage and complaining of pain will be given block.Patients will be placed in lateral position. The transducer will be placed in a longitudinal parasagittal orientation over the transverse process TP at the desired level. After adequate local infiltration, 22 gauge, 10cm Stimuplex needle B Braun Medical Inc., Bethlehem, PA will be inserted caudad to cephalad in plane with the needle contacting the tip of the TP. Correct needle tip position will be confirmed by injection of 1 to 2 mL of 0.9% normal saline solution, and linear fluid spread distending the fascial plane between the erector spinae muscle and the tip of the TP will be observed. After confirming negative aspiration, 20 ml of 0.2% Ropivacaine will be given. 
Intervention  InterTransverese process plane block  Patients with rib fractures presenting to the triage and complaining of pain will be given block. Patients will be placed in lateral position. The transducer will be placed in a longitudinal plane parasagittal orientation over the TP and to identify the Intertransverse tissue complex ITTC. After adequate local infiltration, the needle will be inserted in the caudad to cephalad in plane, with the tip just before contact with the superior costotransverse ligament. Correct needle tip position will be confirmed by injection of 1 to 2 mL of 0.9% normal saline solution and anterior pleural displacement will be identified. After confirming negative aspiration, 20 ml of 0.2% Ropivacaine will be given.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with unilateral multiple(more than one) rib fractures
2. Patients with Visual analog scale value more than 4 
 
ExclusionCriteria 
Details  1. Allergy to local anaesthetic
2. Bleeding disorders
3. Localised infections
4. Neurological disorders
5. Respiratory / cardiac disease
6. Patients not giving consent
7. Patients with poly trauma (cardio thoracic/ CNS) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Efficacy of block as assessed by Visual Analog Scale(VAS) between the Erector spinae plane block and Intertransverse process plane block
 
Baseline (0 hrs), 1 hour,2 hours,6 hours,12 hours,24 hours and 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Diaphragmatic excursion as assessed using M-Mode in Ultrasonography between the groups  baseline(0 hours),6 hrs,24 hrs and 48 hrs post block 
the total dose of rescue analgesia injection
required to achieve adequate analgesia in the
first 48 hours post block between two groups 
rescue analgesia - tramadol 1mg/kg; maximum
dose 3mg/kg over 24 hours.
adequate analgesia - VAS less than 4 
Patient satisfaction score as assessed by Likert’s scale  Likert scale assessed 48 hours post block 
Blood Pressure, Pulse Rate, Respiratory rate, SpO2   0 hrs,6 hrs,12 hrs,24 hrs and 48 hrs post block 
Number of balls lifted in Incentive spirometry  Baseline (0 hrs),6 hrs,24 hrs and 48 hrs post block 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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 
Date of First Enrollment (India)   09/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Randomization: Patients will be randomized using computer-generated random table number

 

 

Methods:

After obtaining approval from Institute Ethics Committee (IEC) and consent, registration will be done in clinical trials registry of India (CTRI) and patients scheduled for intervention who satisfy the inclusion criteria will be recruited for this study. The study participants will be randomized into two groups using computer-generated random table numbers, with allocated ratio of 1:1 into either of the group.

 

Group E: Ultrasound-guided ESP block will be given

Group I:  Ultrasound-guided ITP block will be given

 

The patients who meet the inclusion criteria will be recruited from the triage area. After stabilizing an admitting in the Trauma Intensive Care Unit (TICU), patients will undergo meticulous assessment including meticulous reviewing of medical records, laboratory investigations and chest imaging prior to block administration. Once the pre-block assessment were done and were within normal limits, the patient will be taken for performing the block. After getting informed written consent from the patient, the baseline hemodynamics such as Heart Rate (HR), Non-Invasive Blood Pressure (NIBP), Room air Saturation (SpO2), Respiratory rate (RR), along with Numerical Rating Scale (NRS) will be noted. The blocks will performed under aseptic precautions under ultrasound guidance (Acuson X300â„¢ PE, Siemens Medical Solutions, Malvern, USA) using a high frequency (4-11MHz) linear transducer. All patients will be premedicated with 0.3mg/kg of intravenous midazolam before the procedure.

 

Technique of ESP block:

Patients who received ESP block will be placed in lateral position. The transducer will be placed in a longitudinal parasagittal orientation over the transverse process (TP) at the desired level. After adequate local infiltration, 22 gauge, 10cm Stimuplex needle (B Braun Medical Inc., Bethlehem, PA) will be inserted caudad-to-cephalad in-plane with the needle contacting the tip of the TP. Correct needle tip position will be confirmed by injection of 1 to 2 mL of 0.9% normal saline solution, and linear fluid spread distending the fascial plane between the erector spinae muscle and the tip of the TP will be observed. After confirming negative aspiration, 30 ml of 0.2% Ropivacaine will be given.

 

Technique of ITP block:

Patients who received ESP block will be placed in lateral position.  The transducer will be placed in a longitudinal plane parasagittal orientation over the TP and to identify the Intertransverse tissue complex (ITTC). After adequate local infiltration, the needle will be inserted in the caudad-to-cephalad in-plane, with the tip just before contact with the superior costotransverse ligament. Correct needle tip position will be confirmed by injection of 1 to 2 mL of 0.9% normal saline solution and anterior pleural displacement will be identified.  After confirming negative aspiration, 30 ml of 0.2% Ropivacaine will be given.

 

Before and after performing the block in either of the group, ultrasound measurement of ipsilateral diaphragmatic excursion will be performed in the M-mode during deep breathing using a curved transducer (2-6MHz) applied sub costally in the mid-clavicular perpendicularly to the posterior third of corresponding hemi-diaphragm in supine position.

 

All patients will receive intravenous Paracetamol 1g every 6 hours. The patient will be observed for 48 hours. Whenever VAS equal to or more than 4, intravenous tramadol 1 mg per kg was administered as the rescue analgesic and the total 48  hour analgesic consumption was recorded The VAS, diaphragmatic excursion, hemodynamic parameters, patient satisfaction score and analgesic requirements will be measured immediately, at 6, 12, 24 and 48hours after the procedure. The complications such as pneumothorax, bradycardia, syncope, hypotension, failed block will be noted.

 


 
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