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Completed

NCT Number: NCT06088836

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

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.

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Key information

Conditions

Retrolaminar Block Erector Spinae Plane Block Multiple Rib Fractures Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spirometry

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrolaminar block group

Drug

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.

Drug

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

Primary outcomes

  1. Maximum inspired volume

    Time frame: 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 outcomes

  1. Daily and total rescue analgesics consumption.

    Time frame: 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

  2. Intensive care length of stay.

    Time frame: 28 days after intervention

    Time from admission till Intensive care discharge

  3. Hospital length of stay.

    Time frame: 28 days after intervention

    Time from admission till Hospital discharge

  4. pH

    Time frame: 4 days after intervention.

    pH will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.

  5. PaO2

    Time frame: 4 days after intervention.

    PaO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.

  6. PaCo2

    Time frame: 4 days after intervention.

    PaCo2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.

  7. FiO2

    Time frame: 4 days after intervention.

    FiO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.

  8. Respiratory rate

    Time frame: 4 days after intervention.

    Respiratory rate will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.

  9. Adverse effects and complications.

    Time frame: 4 days after intervention.

    Adverse effects and complications such as hypotension, complications related to catheter insertion, pneumothorax, local anesthetic toxicity, and respiratory depression

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2023
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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