Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Erector Spinae Plane Block

Rib Fractures Clinical Trial

Official title:

Ultrasound-Guided Continuous Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Continuous Erector Spinae Plane Block for Analgesia in Patients With Multiple Traumatic Rib Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506761
• Other study ID #: 35167/12/21
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: August 2022
• Source: Tanta University
• Contact: Ahmed G. ElNawagy
• Phone: 01158170077
• Email: ahmed.nawagy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the quality of analgesic efficacy and improvement of pulmonary function in patients with fracture ribs receiving either continuous rhomboid intercostal block combined with sub-serratus block or continuous erector spinae plane block by comparing and evaluating the differences between the two techniques.

Description:

Rib fractures are common injuries usually following blunt thoracic trauma. Depending on the extent of the injury, rib fractures are associated with a high risk of pulmonary complications, requirement for critical care admission and mechanical ventilation with increased risk of mortality, especially in older patients.

Thoracic pain caused by rib fractures or chest contusion limits patients' coughing and deep breathing, which may cause atelectasis and pneumonia. Patients may also suffer from pulmonary contusion due to injuries and this situation may cause acute respiratory distress syndrome and/or respiratory failure.

The key points in the management of patients with rib fractures are a combination of adequate pain control, respiratory support and physiotherapy.

Previously, pain control of rib fractures has been managed with systemic analgesia alone, with only a minority of patients receiving regional anesthesia. The presence of comorbid conditions, debility and alterations in pharmacodynamics/pharmacokinetics in older patients often results in a higher incidence of adverse effects with systemic analgesia, especially when opioid analgesia is required.

Therefore, different kinds of analgesic techniques have been proposed, including epidural analgesia, local anesthetic infiltration, erector spinae plane (ESP) block, paravertebral block and serratus plane block (SAB) or a combination of the mentioned methods are used to relieve pain.

Erector spinae plane block (ESB) is a novel myofascial plane block introduced into clinical practice. It has been successfully utilized in the management of pain after both rib fractures and surgery of the abdomen and thorax, and in the management of chronic thoracic pain.

The ultrasound-guided rhomboid intercostal block (RIB) and rhomboid intercostal block combined with the sub-serratus plane (RISS) block are two new analgesic techniques work by anesthetizing the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia.

This study suggests that the use of ultrasound-guided continuous ESPB or continuous RIB may improve the analgesia in patients with multiple fracture ribs, decrease the opioid analgesia consumption, and improve the outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult patients between 21 - 60 years.

• Patients with blunt chest trauma.

• Multiple fracture ribs (at least 3 ribs).

• Patients with acute trauma less than 48 hours.

Exclusion Criteria:

• Patients with major trauma outside the chest wall e.g., severe traumatic brain injury or major abdominal visceral injuries.

• Patients with bilateral rib fractures.

• Patients that are intubated and mechanically ventilated.

• Pregnant Individuals.

• Patients with local deformity or infection at the site of injection.

• Sensitivity to local anesthetic drugs.

• Patients with flail chest.

• Patients with Suspected or diagnosed coagulopathy.

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Procedure:
• ultrasound-guided erector spinae plane block
Patients will receive 20 ml plain bupivacaine 0.25 % bolus, then 10 ml per hour plain bupivacaine 0.125 % continuous infusion via ultrasound-guided erector spinae plane block
• ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block
Patients will receive 20 ml plain bupivacaine 0.25 % bolus, then 10 ml per hour plain bupivacaine 0.125 % continuous infusion via ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Bachoumas K, Levrat A, Le Thuaut A, Rouleau S, Groyer S, Dupont H, Rooze P, Eisenmann N, Trampont T, Bohé J, Rieu B, Chakarian JC, Godard A, Frederici L, Gélinotte S, Joret A, Roques P, Painvin B, Leroy C, Benedit M, Dopeux L, Soum E, Botoc V, Fartoukh M, Hausermann MH, Kamel T, Morin J, De Varax R, Plantefève G, Herbland A, Jabaudon M, Duburcq T, Simon C, Chabanne R, Schneider F, Ganster F, Bruel C, Laggoune AS, Bregeaud D, Souweine B, Reignier J, Lascarrou JB. Epidural analgesia in ICU chest trauma patients with fractured ribs: retrospective study of pain control and intubation requirements. Ann Intensive Care. 2020 Aug 27;10(1):116. doi: 10.1186/s13613-020-00733-0. — View Citation

Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6. Review. — View Citation

Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: An overview. Chin J Traumatol. 2020 Jun;23(3):125-138. doi: 10.1016/j.cjtee.2020.04.003. Epub 2020 Apr 20. Review. — View Citation

Jiang CW, Liu F, Zhou Q, Deng W. Comparison of rhomboid intercostal nerve block, erector spinae plane block and serratus plane block on analgesia for modified radical mastectomy: A prospective randomised controlled trial. Int J Clin Pract. 2021 Oct;75(10):e14539. doi: 10.1111/ijcp.14539. Epub 2021 Jul 2. — View Citation

O'Connell KM, Patel KV, Powelson E, Robinson BRH, Boyle K, Peschman J, Blocher-Smith EC, Jacobson L, Leavitt J, McCrum ML, Ballou J, Brasel KJ, Judge J, Greenberg S, Mukherjee K, Qiu Q, Vavilala MS, Rivara F, Arbabi S. Use of regional analgesia and risk of delirium in older adults with multiple rib fractures: An Eastern Association for the Surgery of Trauma multicenter study. J Trauma Acute Care Surg. 2021 Aug 1;91(2):265-271. doi: 10.1097/TA.0000000000003258. — View Citation

Ostermann RC, Joestl J, Lang N, Tiefenboeck TM, Ohnesorg S, Platzer P, Hofbauer M. Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome. Injury. 2021 Jun;52(6):1316-1320. doi: 10.1016/j.injury.2021.02.033. Epub 2021 Feb 17. — View Citation

Peek J, Beks RB, Hietbrink F, Heng M, De Jong MB, Beeres FJP, Leenen LPH, Groenwold RHH, Houwert RM. Complications and outcome after rib fracture fixation: A systematic review. J Trauma Acute Care Surg. 2020 Aug;89(2):411-418. doi: 10.1097/TA.0000000000002716. — View Citation

Warfield DJ Jr, Barre S, Adhikary SD. Current understanding of the fascial plane blocks for analgesia of the chest wall: techniques and indications update for 2020. Curr Opin Anaesthesiol. 2020 Oct;33(5):692-697. doi: 10.1097/ACO.0000000000000909. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid analgesic consumption per day		4 days
Secondary	change in pain scores by Numerical rating score (NRS) after the procedure		4 days
Secondary	Time to First rescue analgesic request.		4 days
Secondary	Patient satisfaction.		4 days
Secondary	Changes in heart rate.		4 days
Secondary	Changes in mean arterial blood pressure.		4 days
Secondary	Incidence of adverse effects.		4 days
Secondary	Incidence of respiratory complications.		4 days