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Recruiting 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

No phase Interventional Erector Spinae Block Edge of Laminar Block Analgesia Diaphragmatic Excursion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector spinae block, Edge of lamina block.
Who it may be relevant to
Registry conditions: Erector Spinae Block, Edge of Laminar Block, Analgesia, Diaphragmatic Excursion. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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.

Overview

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.

Detailed description

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.

Interventions

  • Other Erector spinae block
    Patients will receive continuous ipsilateral erector spinae plane block.
  • Other Edge of lamina block
    Patients will receive continuous ipsilateral edge of laminar block.

Primary outcome measures

  • Total morphine consumption [Time frame: 4 days postoperatively]
Secondary outcome measures (6)
  • Degree of pain [Time frame: 4 days postoperatively]
  • Diaphragmatic excursion [Time frame: 4 days postoperatively]
  • Incidence of adverse events [Time frame: 4 days postoperatively]
  • Forced vital capacity [Time frame: 4 days postoperatively]
  • Forced expiratory volume 1 [Time frame: 4 days postoperatively]
  • Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC) [Time frame: 4 days postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07069101 · 36265MD297/10/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗