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

April 21, 2024 updated by: Mohammed mamdouh mohammed mahmoud, Assiut University

Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

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
      • Assiut, Egypt, 71515
        • Assiut University

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

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
Experimental: 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.
Procedure: 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
Active Comparator: 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.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain score
Time Frame: before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inspiratory volumes (mL)
Time Frame: before and after block at "90 minutes" then every "12hours" for 3 days
Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device
before and after block at "90 minutes" then every "12hours" for 3 days
change in Serum beta-endorphin level
Time Frame: before procedure and at 24 hours post procedure
We will use radioimmunoassays to measure plasma beta-endorphin level
before procedure and at 24 hours post procedure
Lung Ultrasound Score (LUSS)
Time Frame: before and after block at "90 minutes" then every "24 hours" for 3 days
We will use a techniques based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound ,The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 24).
before and after block at "90 minutes" then every "24 hours" for 3 days
mean arterial blood pressure
Time Frame: before and after the block every "2hours" for 3 days
mean arterial blood pressure by non invaisive blood pressure monitoring
before and after the block every "2hours" for 3 days
heart rate
Time Frame: before and after the block every "2hours" for 3 days
heart rate by EKG monitor
before and after the block every "2hours" for 3 days
peripheral arterial oxygen saturation (SpO2)
Time Frame: before and after the block every "2hours" for 3 days
measured by Pulse oximetry
before and after the block every "2hours" for 3 days

Collaborators and Investigators

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

Sponsor

Assiut 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)

August 3, 2021

Primary Completion (Actual)

December 10, 2023

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

September 20, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Estimated)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Serratus Plane Block and MFRs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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