Prospective Comparative Study Between Ultrasound-guided Continuous Erector Spinae Plane Block and the Use of Intravenous Patient Controlled Analgesia for Management of Pain in Patients With Multiple Fracture Ribs

NCT ID: NCT05975294

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-08-31

Brief Summary

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Rib fractures are common after blunt injury to the chest. Present in 10% of blunt trauma admissions. Pain associated with rib fractures can result in compromise of pulmonary function causing hypoxaemia or pneumonia, which may require mechanical ventilation. Adequate relief of rib fracture pain allows the patient to breathe deeply, avoid intubation and clear secretions effectively, which will minimise the pulmonary complications .

Pain control is essential for not only primary pain relief but also preventing secondary complications such as atelectasis or pneumonia as well as the transition to chronic pain. Accordingly, further steps are now being taken from the conventional pain control medication and techniques by the introduction of more aggressive pain control measures .Traditional regional anaesthesia (RA) techniques such as paravertebral, intercostal and epidurals injections are resource-intensive and time-consuming, limited to single dermatomes; provide incomplete analgesia of the hemithorax; and are associated with significant potential complications such as local anaesthetic intoxication, vasovagal syncope, hemi diaphragmatic paresis and pneumothorax .

The erector spinae plane block (ESPB) is a novel fascial plane block. Its use has been documented in numerous instances with positive outcomes in controlling acute as well as chronic pain. The most popular technique was the continuous infusion through a catheter . Fascial plane blocks that can be used for rib fracture pain management are serratus anterior plane block, erector spinae plane block and the rhomboid intercostal and subserratus (RISS) block. The procedure is more simple to use with a lower incidence of complications ,less time consuming , more superficial than others so it can be used in patients on anticoagulant therapy .

Providing analgesia for patients with rib fractures continues to be a management challenge. Therefore, further studies are needed comparing between different techniques to prove their efficacy in pain management

Detailed Description

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Conditions

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Multiple Fracture Ribs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group(E):

including 30 patients with multiple fracture ribs will undergo ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.

Group Type ACTIVE_COMPARATOR

amixture 0.125% bupivicaine with fentanyl

Intervention Type DRUG

ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.

Group (C)

including 30 patients with multiple fracture ribs will be given intravenous PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.

Group Type ACTIVE_COMPARATOR

100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset

Intervention Type DRUG

PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.

Interventions

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amixture 0.125% bupivicaine with fentanyl

ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.

Intervention Type DRUG

100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset

PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* • Age 18:60 years

* Patient with 2 or more unilateral rib fractures.
* ASA 1 , ASA 2

Exclusion Criteria

* • patient refusal

* History of chronic pain or daily use of analgesics
* History of psychiatric disorder or inability to understand the consent form or how to use a visual analog scale (VAS) for pain measurement
* Severe renal or hepatic dysfunction
* Allergy to any required drug
* Second thoracic surgery
* Local infection at the injection site
* Spinal deformity
* head injury
* lung complications related to trauma ( pneumothorax , haemothorax , lung collapse).
* need of mechanical ventilation
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahmoud Azmy

assistant lecteurer anaethesia and ICU department sohag univerisity hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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ahmed m azmy, assistant lecutrer

Role: CONTACT

01004793896

elhdad A MOUSA, professor

Role: CONTACT

References

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Truitt MS, Murry J, Amos J, Lorenzo M, Mangram A, Dunn E, Moore EE. Continuous intercostal nerve blockade for rib fractures: ready for primetime? J Trauma. 2011 Dec;71(6):1548-52; discussion 1552. doi: 10.1097/TA.0b013e31823c96e0.

Reference Type BACKGROUND
PMID: 22182865 (View on PubMed)

Kumar G, Kumar Bhoi S, Sinha TP, Paul S. Erector spinae plane block for multiple rib fracture done by an Emergency Physician: A case series. Australas J Ultrasound Med. 2020 Aug 30;24(1):58-62. doi: 10.1002/ajum.12225. eCollection 2021 Feb.

Reference Type BACKGROUND
PMID: 34760612 (View on PubMed)

Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.

Reference Type BACKGROUND
PMID: 25210700 (View on PubMed)

Picard J, Meek T. Complications of regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:105-15. doi: 10.1111/j.1365-2044.2009.06205.x.

Reference Type BACKGROUND
PMID: 20377552 (View on PubMed)

Other Identifiers

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Soh-Med-23-07-01MD

Identifier Type: -

Identifier Source: org_study_id

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