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

August 17, 2022 updated by: Ahmed Gamal Mahmoud ElNawagy, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt
        • Recruiting
        • Tanta University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group I
This group includes patients with rib fractures receiving patient-controlled analgesia.
Experimental: Group II
This group includes patients with rib fractures receiving continuous ultrasound-guided erector spinae plane block.
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
Experimental: Group III
This group includes patients with rib fractures receiving continuous ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total opioid analgesic consumption per day
Time Frame: 4 days
4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
change in pain scores by Numerical rating score (NRS) after the procedure
Time Frame: 4 days
4 days
Time to First rescue analgesic request.
Time Frame: 4 days
4 days
Patient satisfaction.
Time Frame: 4 days
4 days
Changes in heart rate.
Time Frame: 4 days
4 days
Changes in mean arterial blood pressure.
Time Frame: 4 days
4 days
Incidence of adverse effects.
Time Frame: 4 days
4 days
Incidence of respiratory complications.
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35167/12/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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