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

Not Applicable

Recruiting

• Conditions: Retrolaminar Block; Spirometry; Multiple Rib Fractures; Erector Spinae Plane Block; Pain
• Interventions: Drug: Erector spinae plane block group.; Drug: Retrolaminar block group

• Registration Number: NCT06088836
• Lead Sponsor: Tanta University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-12
• Study Start: 2023-10-18
• Study First Posted: 2023-10-18
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (Erector spinae plane block group)	Erector spinae plane block group.	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
Group I (Retrolaminar block group)	Retrolaminar block group	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

Primary Outcome Measures

Name	Time	Method
Maximum inspired volume	4 days after intervention.	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.

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	4 days after intervention.	Respiratory rate will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
Intensive care length of stay.	28 days after intervention	Time from admission till Intensive care discharge
Adverse effects and complications.	4 days after intervention.	Adverse effects and complications such as hypotension, complications related to catheter insertion, pneumothorax, local anesthetic toxicity, and respiratory depression
Hospital length of stay.	28 days after intervention	Time from admission till Hospital discharge
Daily and total rescue analgesics consumption.	24 hours after intervention.	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
PaO2	4 days after intervention.	PaO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
pH	4 days after intervention.	pH will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
PaCo2	4 days after intervention.	PaCo2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
FiO2	4 days after intervention.	FiO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt