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

A

Assiut University

Status

Completed

Conditions

Fracture; Rib, Multiple

Treatments

Device: Ultrasound
Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution
Drug: Bupivacaine HCl Inj 0.25%

Study type

Interventional

Funder types

Other

Identifiers

NCT03853330
Analgesia for Fracture Ribs

Details and patient eligibility

About

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

Full 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.

Enrollment

108 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

108 participants in 2 patient groups

Thoracic Epidural Analgesia group
Active Comparator group
Description:
25 patients will receive ultrasound-guided thoracic epidural analgesia for multiple fracture ribs at the level of T8 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used.
Treatment:
Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution
Drug: Bupivacaine HCl Inj 0.25%
Device: Ultrasound
Erector spinae plane block group
Active Comparator group
Description:
25 patients will receive ultrasound-guided ESP block for multiple fracture ribs at the level from T1 to T5 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used.
Treatment:
Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution
Drug: Bupivacaine HCl Inj 0.25%
Device: Ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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