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NCT Number: NCT07069101

Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures

This prospective randomized clinical trial aims to compare the effect of continuous erector spinae plane block versus continuous edge of laminar block on the quality of analgesia and diaphragmatic excursion in patients with unilateral traumatic multiple rib fractures.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Heba A Muhammed, Master

CONTACT

[email protected]

00201032901343

Mohammed M Abu El Yazed, MD

SUB_INVESTIGATOR

Mona B Fayad, MD

SUB_INVESTIGATOR

Saad A Mohammed, MD

SUB_INVESTIGATOR

Shaimaa F Abdelkader, MD

SUB_INVESTIGATOR

About this study

Rib fractures occur in up to 12% of all trauma patients, most commonly due to blunt thoracic trauma, and pose a significant health care burden with their associated morbidity and mortality.

The erector spinae plane block (ESB) is a myofascial plane technique in which a needle is inserted under ultrasound guidance deep to the erector spinae muscle group, allowing an infusion of local anesthetic to diffuse to both the dorsal and ventral rami of the spinal nerves, thereby supplying the rib cage. This technique can be used as a single-shot method or to facilitate the placement of a catheter, allowing for continuous infusion and/or intermittent bolus to provide long-lasting analgesia.

The edge of laminar block (ELB) is a novel technique in which local anesthetics are injected at the lateral edge of the lamina. It has been proven to provide sensory analgesia during rib fractures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 21 and 65 years.
  • Both sexes.
  • With unilateral traumatic multiple fracture ribs (≥ 3), admitted to the surgical intensive care unit within the first day of trauma.

Exclusion criteria

  • Patients' rejection.
  • Body mass index ≥ 35 (kg/m2).
  • Bleeding and Coagulation disorders.
  • Known hypersensitivity to the study drugs.
  • Vertebral deformity.
  • Respiratory, cardiac, renal or hepatic dysfunction.
  • Patients with major trauma involving extra-thoracic structures (e.g., head, spine, pelvis, and abdominal visceral injuries).
  • Mental or cognitive dysfunction,
  • History of chronic analgesic or drug abuse.
  • Local infection at the site of the block.

Treatment and study plan

erector spinae block

Other

Patients will receive continuous ipsilateral erector spinae plane block.

Edge of lamina block

Other

Patients will receive continuous ipsilateral edge of laminar block.

Primary outcomes

  1. Total morphine consumption

    Time frame: 4 days postoperatively

    If the Numeric Rating Scale (NRS) is 4 or more IV morphine 3mg will be given.

Secondary outcomes

  1. Degree of pain

    Time frame: 4 days postoperatively

    The degree of pain will be assessed using the Numeric Rating Scale (NRS) at rest and on coughing will be assessed before the block, at 60 minutes after the block, and then every 8 hours for 4 days.

  2. Diaphragmatic excursion

    Time frame: 4 days postoperatively

    Diaphragmatic excursion will be assessed before the block, at 60 minutes after the block, and then every 8 hours for 4 days.

  3. Incidence of adverse events

    Time frame: 4 days postoperatively

    Incidence of adverse events such as hematoma, local anesthetic systemic toxicity, respiratory complications, pneumothorax, nausea, and vomiting.

  4. Forced vital capacity

    Time frame: 4 days postoperatively

    Forced vital capacity (FVC) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.

  5. Forced expiratory volume 1

    Time frame: 4 days postoperatively

    Forced expiratory volume 1 (FEV1) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.

  6. Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC)

    Time frame: 4 days postoperatively

    Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Heba A Muhammed, Master

CONTACT

[email protected]

00201032901343

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Effect of Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures. A Prospective Randomized Trail.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 20, 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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