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

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.