| 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
|
|
|
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
|
|
|
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 X300™ 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. |