Clinical trial NCT05506761: Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Erector Spinae Plane Block
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rib Fractures
Keywords: Rib Fractures
Intercostal nerve block
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total opioid analgesic consumption per day
timeFrame: 4 days
Secondary outcomes:
measure: change in pain scores by Numerical rating score (NRS) after the procedure
timeFrame: 4 days
measure: Time to First rescue analgesic request.
timeFrame: 4 days
measure: Patient satisfaction.
timeFrame: 4 days
measure: Changes in heart rate.
timeFrame: 4 days
measure: Changes in mean arterial blood pressure.
timeFrame: 4 days
measure: Incidence of adverse effects.
timeFrame: 4 days
measure: Incidence of respiratory complications.
timeFrame: 4 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbia
Study officials:
References:
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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.
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