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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088836
• Other study ID #: 36264MD35/2/23
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: October 2023
• Source: Tanta University
• Contact: Hossam I Ibrahim, Master
• Phone: 00201093230200
• Email: hossam.hesham[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Fractures, Bone
• Multiple Rib Fractures
• Pain
• Retrolaminar Block
• Rib Fractures
• Spirometry

Intervention

Drug:
• Retrolaminar block group
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.
• Erector spinae plane block group.
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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Intensive care length of stay.	Time from admission till Intensive care discharge	28 days after intervention
Secondary	Hospital length of stay.	Time from admission till Hospital discharge	28 days after intervention
Secondary	pH	pH will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.	4 days after intervention.
Secondary	PaO2	PaO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.	4 days after intervention.
Secondary	PaCo2	PaCo2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.	4 days after intervention.
Secondary	FiO2	FiO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.	4 days after intervention.
Secondary	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.
Secondary	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.