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

Fracture; Rib, Multiple Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853330
• Other study ID #: Analgesia for Fracture Ribs
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fracture; Rib, Multiple
• Fractures, Bone

Intervention

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

Drug:
• Bupivacaine HCl Inj 0.25%
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
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.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score (verbal numeric rating scale) as the median VNRS at rest and cough	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.	up to 24 hours
Secondary	Pulmonary function test	Pulmonary function test will be done before the block, 60 minutes after the block and then every 6 hours up to 24 hours.	up to 24 hours