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.

Study Overview

• Status: Completed
• Conditions: Fracture; Rib, Multiple
• Intervention / Treatment: Device: Ultrasound; Drug: Bupivacaine HCl Inj 0.25%; Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic Epidural Analgesia group; 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.	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; Drug: 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.
Active Comparator: Erector spinae plane block group; 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.	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; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma; Fractures, Bone; Fractures, Multiple; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Analgesia for Fracture Ribs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No