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

NCT04575272 | Completed

• 1 other identifier: Serratus Plane Block and MFRs
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Rib Fractures; Pain, Acute; Serratus Anterior Plane Block

Keywords

serratus anterior plane block; multiple rib fractures

Outcome Measures

Primary Outcomes (1)

• Change in pain score

  patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable"

  before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"

Secondary Outcomes (6)

• Change in inspiratory volumes (mL)

  before and after block at "90 minutes" then every "12hours" for 3 days

• change in Serum beta-endorphin level

  before procedure and at 24 hours post procedure

• Lung Ultrasound Score (LUSS)

  before and after block at "90 minutes" then every "24 hours" for 3 days

• mean arterial blood pressure

  before and after the block every "2hours" for 3 days

• heart rate

  before and after the block every "2hours" for 3 days

Study Arms (2)

Continuous Deep Serratus Anterior Plane Block group

EXPERIMENTAL

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.

Procedure: Ultrasound-guided continuous serratus anterior plane block

Continuous Superficial Serratus Anterior Plane Block group

ACTIVE COMPARATOR

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.

Procedure: Ultrasound-guided continuous serratus anterior plane block

Interventions

Ultrasound-guided continuous serratus anterior plane block PROCEDURE

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

Continuous Deep Serratus Anterior Plane Block group; Continuous Superficial Serratus Anterior Plane Block group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (16)

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

  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.

  PMID: 28241883 BACKGROUND

• 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.

  PMID: 19561823 BACKGROUND

• 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.

  PMID: 27134973 BACKGROUND

• 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.

  PMID: 27939192 BACKGROUND

• 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.

  PMID: 31447581 BACKGROUND

• 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.

  PMID: 28447227 BACKGROUND

• 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.

  PMID: 32165553 BACKGROUND

• 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.

  PMID: 23923989 BACKGROUND

• 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.

  PMID: 27595172 BACKGROUND

• 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.

  PMID: 28079733 BACKGROUND

• 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.

  PMID: 27587333 BACKGROUND

• Bhoi D, Selvam V, Yadav P, Talawar P. Comparison of two different techniques of serratus anterior plane block: A clinical experience. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):251-253. doi: 10.4103/joacp.JOACP_294_16. No abstract available.

  PMID: 30104841 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

  PMID: 16984837 BACKGROUND

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  PMID: 22392031 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: neither the patient or the investigator included in data collection will be aware of the type of block performed or the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: October 5, 2020
• Study Start: August 3, 2021
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

EG (1)