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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03853330
Enrollment
108
Registered
2019-02-25
Start date
2019-12-01
Completion date
2021-12-30
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture; Rib, Multiple

Brief summary

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

Detailed 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.

Interventions

DEVICEUltrasound

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

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

DRUGBupivacaine 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

prospective, double-blinded controlled trial; both the patient and data collector is unaware of the study nature

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain score (verbal numeric rating scale) as the median VNRS at rest and coughup to 24 hoursAll 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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026