Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures

NCT ID: NCT04575272

Last Updated: 2024-04-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2023-12-10

Brief Summary

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The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.

Detailed Description

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Thoracic blunt trauma, especially when multiple rib fractures are associated, is challenging to manage and causes significant morbidity due to the severe pain implied.

Patients can present with respiratory compromise as their capacity to expand the thorax is limited by pain. As a result, they are at high risk to develop atelectasis and pneumonia.

the key goal of management is adequate analgesia and pulmonary volume expansion Various strategies to treat such pain have been utilized, including regional analgesia (intrapleural, intercostal paravertebral nerve blockade), and neuraxial analgesia (thoracic epidural analgesia (TEA), intrathecal opioids).

The use of neuraxial analgesia in polytrauma is frequently limited by the need for aggressive venous thromboembolic (VTE) prophylaxis, and positioning of the patient for a neuraxial approach may be impossible.

There is a growing interest in exploring treatments that are less invasive than EA and can be performed on patients who have contraindications to neuraxial analgesia. Ultrasound-guided Serratus Anterior Plane (SAP) block is a recent technique, first described by Blanco et al. in 2013, that provides analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. It is a safe, simple to perform block with no significant contraindications or side effects. he described 2 potential spaces, one superficial and another deep to serratus. The SAPB has been used effectively for the management of pain in the context of rib fractures, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome, few studies compared the two approaches, and the difference between them has not yet been studied in patients with multiple rib fractures.

Conditions

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Multiple Rib Fractures Pain, Acute Serratus Anterior Plane Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
neither the patient or the investigator included in data collection will be aware of the type of block performed or the group allocation

Study Groups

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Continuous Deep Serratus Anterior Plane Block group

at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately deep to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started.

Group Type EXPERIMENTAL

Ultrasound-guided continuous serratus anterior plane block

Intervention Type PROCEDURE

Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib

Continuous Superficial Serratus Anterior Plane Block group

at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately superficial to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started.

Group Type ACTIVE_COMPARATOR

Ultrasound-guided continuous serratus anterior plane block

Intervention Type PROCEDURE

Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib

Interventions

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Ultrasound-guided continuous serratus anterior plane block

Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads.

Exclusion Criteria

* significant head injury and unconsciousness (GCS less than 14)
* Patients with significant pain from other injuries
* pathological obesity (body mass index ≥35)
* history of drug allergy local anesthetics
* local infection at the injection site
* inability to obtain consent from patient or surrogate, and patient refusal
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed mamdouh mohammed mahmoud

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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May L, Hillermann C, Patil S. Rib fracture management. BJA Educ. 2016 Jan 1;16(1):26-32.

Reference Type BACKGROUND

Chien CY, Chen YH, Han ST, Blaney GN, Huang TS, Chen KF. The number of displaced rib fractures is more predictive for complications in chest trauma patients. Scand J Trauma Resusc Emerg Med. 2017 Feb 28;25(1):19. doi: 10.1186/s13049-017-0368-y.

Reference Type BACKGROUND
PMID: 28241883 (View on PubMed)

Lotfipour S, Kaku SK, Vaca FE, Patel C, Anderson CL, Ahmed SS, Menchine MD. Factors associated with complications in older adults with isolated blunt chest trauma. West J Emerg Med. 2009 May;10(2):79-84.

Reference Type BACKGROUND
PMID: 19561823 (View on PubMed)

Vasigh A, Jaafarpour M, Khajavikhan J, Khani A. The Effect of Gabapentin Plus Celecoxib on Pain and Associated Complications After Laminectomy. J Clin Diagn Res. 2016 Mar;10(3):UC04-8. doi: 10.7860/JCDR/2016/17923.7346. Epub 2016 Mar 1.

Reference Type BACKGROUND
PMID: 27134973 (View on PubMed)

Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.

Reference Type BACKGROUND
PMID: 27939192 (View on PubMed)

Hernandez N, de Haan J, Clendeninn D, Meyer DE, Ghebremichael S, Artime C, Williams G, Eltzschig H, Sen S. Impact of serratus plane block on pain scores and incentive spirometry volumes after chest trauma. Local Reg Anesth. 2019 Aug 2;12:59-66. doi: 10.2147/LRA.S207791. eCollection 2019.

Reference Type BACKGROUND
PMID: 31447581 (View on PubMed)

Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.

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PMID: 28447227 (View on PubMed)

Beard L, Hillermann C, Beard E, Millerchip S, Sachdeva R, Gao Smith F, Veenith T. Multicenter longitudinal cross-sectional study comparing effectiveness of serratus anterior plane, paravertebral and thoracic epidural for the analgesia of multiple rib fractures. Reg Anesth Pain Med. 2020 May;45(5):351-356. doi: 10.1136/rapm-2019-101119. Epub 2020 Mar 11.

Reference Type BACKGROUND
PMID: 32165553 (View on PubMed)

Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

Reference Type BACKGROUND
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Durant E, Dixon B, Luftig J, Mantuani D, Herring A. Ultrasound-guided serratus plane block for ED rib fracture pain control. Am J Emerg Med. 2017 Jan;35(1):197.e3-197.e6. doi: 10.1016/j.ajem.2016.07.021. Epub 2016 Jul 19. No abstract available.

Reference Type BACKGROUND
PMID: 27595172 (View on PubMed)

Piracha MM, Thorp SL, Puttanniah V, Gulati A. "A Tale of Two Planes": Deep Versus Superficial Serratus Plane Block for Postmastectomy Pain Syndrome. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):259-262. doi: 10.1097/AAP.0000000000000555.

Reference Type BACKGROUND
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Zocca JA, Chen GH, Puttanniah VG, Hung JC, Gulati A. Ultrasound-Guided Serratus Plane Block for Treatment of Postmastectomy Pain Syndromes in Breast Cancer Patients: A Case Series. Pain Pract. 2017 Jan;17(1):141-146. doi: 10.1111/papr.12482. Epub 2016 Sep 2.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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Serratus Plane Block and MFRs

Identifier Type: -

Identifier Source: org_study_id

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