Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block in Multiple Rib Fractures

Study Overview
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Brief Summary
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The aim of this study is to compare the incentive spirometry volume and analgesic efficacy of ultrasound guided continuous Retrolaminar block and continuous Erector spinae plain block in patients with multiple rib fractures.

Detailed Description
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Thoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) are strongly recommended techniques for managing thoracic neuropathic pain However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia (TEA)and potential risk of pneumothorax in thoracic paravertebral block (TPVB).Newer approaches have been the focus of many studies in recent years; these approaches include retrolaminar block and erector spinae plane block. Retrolaminar block (RLB) is a new thoracic truncal block for controlling somatic pain in both the thoracic and abdominal walls. The Erector Spinae plane block (ESPB) has been used successfully to manage severe neuropathic pain arising from ribs .The basis to use ESPB is its likely site of action which is the dorsal and ventral rami of the thoracic spinal nerves.

Official Title
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Impact of Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block on Incentive Spirometry Volumes and Pain Scores in Multiple Rib Fractures

Conditions
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Spirometry, Retrolaminar Block, Erector Spinae Plane Block, Pain, Multiple Rib Fractures

Intervention / Treatment
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* Drug: Retrolaminar block group
* Drug: Erector spinae plane block group.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 65 years old. Both sexes. Patients with unilateral multiple traumatic rib fractures (≥ 3 ribs). Exclusion Criteria: 1st ken refusal. Patients with any contraindication for regional block as: Bleeding disorders. Infection at the injection site. Patients with hemodynamic instability. Patients with known hypersensitivity to the study drugs Unconscious patients Patients with significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries Patients with significant lung contusions, pneumothorax, flail chest Chronic opioid users. Uncooperative patients and patients with psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (Retrolaminar block group)<br>Patients received ultrasound guided Retrolaminar block bolus dose of 20 ml 0.25% bupivacaine then continuous infusion at a rate of 0.1 mL/kg/hr. for 4 days | Drug: Retrolaminar block group<br>* Under complete aseptic precautions and sterilization and in sitting position, A high-frequency linear ultrasound probe (6-11 MHz) was placed into a longitudinal orientation in the paraspinous line 1 cm from the midline. Lamina appeared as a continuous line interrupted by the intra laminar spaces. local infiltration of needle insertion site with 3ml of 2.0 % lidocaine was done Then, an 18-gauge Tuohy needle was inserted in plane 1 cm lateral to the spinous process using ultrasound imaging and advanced caudally or cranially until it contacts the lamina.<br>|
| Experimental: Group II (Erector spinae plane block group)<br>Patients received ultrasound guided Erector spinae plane block bolus dose of 20 ml 0.25% bupivacaine then continuous infusion at a rate of 0.1 mL/kg/hr. for 4 days | Drug: Erector spinae plane block group.<br>* Under complete aseptic precautions and sterilization and in sitting position, A high-frequency ultrasound transducer was placed in a longitudinal orientation 3 cm lateral to the midline midway between the uppermost and the lowest fractured rib to identify counting of ribs using ultrasound three muscles were identified as superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. However, when the rhomboid major muscle disappears this indicates that we are at the level of the seventh thoracic vertebra. local infiltration of needle insertion site with 3ml of 2.0 % lidocaine was done. Then, an 18-gauge Tuohy needle was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum inspired volume | Maximum inspired volume will be measure by incentive spirometry which indicate less pain. Inspiratory capacity (IC) measured by Incentive Spirometry before the block, 30 minutes, 60 minutes after the blocks and then every six hours for subsequent 4 days. | 4 days after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily and total rescue analgesics consumption. | Need for rescue analgesia and the total consumption of morphine in the form of incremental doses (0.05mg /kg) if Visual Analogue Score (VAS) ≥4 Pain score will be measured by Visual Analogue Score (VAS) from 0 to 10. Where 0: no pain, 10: the worst pain | 24 hours after intervention. | 
| Intensive care length of stay. | Time from admission till Intensive care discharge | 28 days after intervention | 
| Hospital length of stay. | Time from admission till Hospital discharge | 28 days after intervention | 
| pH | pH will be measure before the block ,6 hours after the block and then daily for subsequent 4 days. | 4 days after intervention. | 
| PaO2 | PaO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days. | 4 days after intervention. | 
| PaCo2 | PaCo2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days. | 4 days after intervention. | 
| FiO2 | FiO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days. | 4 days after intervention. | 
| Respiratory rate | Respiratory rate will be measure before the block ,6 hours after the block and then daily for subsequent 4 days. | 4 days after intervention. | 
| Adverse effects and complications. | Adverse effects and complications such as hypotension, complications related to catheter insertion, pneumothorax, local anesthetic toxicity, and respiratory depression | 4 days after intervention. |