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Completed

NCT Number: NCT03853330

Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs

To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs.

Completed

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, 71111, Egypt

About this study

Erector spinae plane (ESP) block is a recently described technique which may be an alternative to Paravertebral block (PVB) for providing thoracic analgesia. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. ESP is a more superficial block with a better defined end-point injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. ESP does not have the same risk of pneumothorax as PVB.

Epidural analgesia has become the standard of care. Although thoracic epidurals provide excellent analgesia for the management of rib fractures, they are limited to a certain population due to patient factors and side-effects. Many trauma patients have other injuries which contraindicate the use of epidurals, or which prevent positioning for insertion. There are disadvantages to thoracic epidural analgesia. They are technically challenging to insert, with a risk of dural puncture or spinal cord injury. Adverse effects include hypotension, and if opioids used, urinary retention and pruritus. Patients can develop a motor block and are unable to mobilize with an epidural in situ.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with multiple fracture ribs.

Exclusion criteria

  • Patient refusal.
  • Patients with pre-existing infection at the block site.
  • Coagulopathy.
  • Allergy to local anesthetics.
  • Pre-existing neurological deficits.
  • Psychiatric illness.

Treatment and study plan

Ultrasound

Device

Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.

Bupivacaine HCl Inj 0.25%

Drug

Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml

Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution

Drug

infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.

Primary outcomes

  1. Pain score (verbal numeric rating scale) as the median VNRS at rest and cough

    Time frame: up to 24 hours

    All patients will be assessed for pain score using the 11 points verbal numeric rating scale (VNRS), where zero equals no pain and 10 equals the worst pain imaginable. This assessment will be done before the block and after the block by 60 minutes and then every 6 hours up to 24 hours.

Secondary outcomes

  1. Pulmonary function test

    Time frame: up to 24 hours

    Pulmonary function test will be done before the block, 60 minutes after the block and then every 6 hours up to 24 hours.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2019
Registry last updated
Mar 14, 2022

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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