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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03853330

Collaborator

(none)

108

Enrollment

Location

Arms

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fracture; Rib, Multiple	Device: Ultrasound Drug: Bupivacaine HCl Inj 0.25% Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 1, 2019

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain score (verbal numeric rating scale) as the median VNRS at rest and cough [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 Outcome Measures

Pulmonary function test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospital	Assiut		Egypt	71111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rasha Hamed, Ass. Prof. in Anesthesia and ICU, Assiut University

ClinicalTrials.gov Identifier:

NCT03853330

Other Study ID Numbers:

Analgesia for Fracture Ribs

First Posted:

Feb 25, 2019

Last Update Posted:

Mar 14, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Fractures, Multiple

Bupivacaine

Study Results

No Results Posted as of Mar 14, 2022