Ultrasound-Guided Continuous Serratus Anterior Plane Block vs Dexmedetomidine Infusion in Patients With Rib Fractures.

October 9, 2023 updated by: Dina Mahmoud Fakhry, Beni-Suef University

Ultrasound-Guided Continuous Serratus Anterior Plane Block Versus Intravenous Dexmedetomidine Infusion for Pain Control in Patients With Multiple Rib Fractures: A Prospective Randomized Clinical Trial.

The aim of this work is to compare analgesic efficacy in patients with multiple rib fractures who will be managed with Ultrasound-guided continuous serratus anterior plane block versus patients who will be managed with dexmedetomidine infusion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In thoracic trauma patients with rib fractures, the ability to cough and clear secretions is impaired by pain, leading to an increased risk of atelectasis, retention of secretions, chest infections and prolonged ICU stay thereby leads to significant morbidity, mortality and cost of treatment.Hence, aggressive pain management is a vital component of rib fracture management for the healing of rib fractures, improvement of pulmonary functions, and pulmonary rehabilitation.

The number of rib fractures >3, rib fracture locations, bilateral rib fractures, intraparenchymal pulmonary injuries, flail chest, and a first rib fracture influence the mortality rates.

The involvement of acute pain services in Multiple rib fractures (MRFs) is based on "Rib Fracture score". Rib fracture score = (breaks × sides) + age factor. "Breaks" is the total number of fractures to the rib. Score of 1 is for unilateral fractures and 2 for bilateral fractures. Age is factored into the equation due to an increased risk of complications (age factor = 0 if <50 years; 1 if 51-60 years; 2 if 61-70 years; 3 if 71-80 years; 4 if above 80 years). A score >7, requires the involvement of acute pain team.

There is a wide variety of strategies for treating acute pain , including multimodal opioid and non-opioid systemic analgesics, regional anesthesia including thoracic epidural analgesia (TEA), paravertebral blocks (PVB),intercostal nerve blocks and a recent expansion in the use of novel fascial plane blocks.

Ultrasound-guided Serratus Anterior Plane (SAP) block is an ultrasound (US) guided interfascial plane block which has been used in managing pain due to MRFs. It is a relatively recent technique, first described in 2013, that provides almost complete analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. Two planes were described, one superficial to serratus anterior muscle and second underneath the muscle and above the rib. It is a safe, simple to perform block with no significant contraindications or side effects. It can be performed in patients lying supine, rendering it particularly useful in polytrauma patients who are unable to sit up or turn lateral for regional blocks on the back. It can be safely given to polytrauma patients who may be having hemodynamic instability or coagulopathy, unlike epidural and paravertebral. There is a theoretical possibility of local anesthetic toxicity and hematoma such as other interfacial plane blocks. Pneumothorax is a potential complication, but under ultrasound guidance, it would be a remote possibility as the injection is far from the pleura between two muscles or above the rib.

Use of continuous techniques using catheters has the benefit of providing prolonged analgesia titrated to patient response.

Dexmedetomidine is a highly selective α-2 adrenoceptor agonist. It has sympatholytic, sedative, amnestic, and analgesic properties. It provides a unique analgesia, without respiratory depression best described as opioid- sparing. The analgesic properties of α-2 agonists are mediated by Supraspinal (locus ceruleus) and spinal (dorsal horn) mechanisms. Also it decreases sympathetic outflow through a central action in a dose-dependent manner, and these presynaptic sites of action are clinically significant because they modulate the release of norepinephrine. This inhibitory effect on neurotransmitter release is mediated by the blockage of calcium entry into nerve terminals. Systemic administration of the α-2 agonists has been tested in the perioperative period. The reduced opioid requirement was a feature of the administration of such group of medications. This feature is indirect evidence that these drugs have analgesic action. However, the perioperative period involves many conflicting factors. Clearly, the sedative effect may be the reason behind the reduced opioid requirements.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Beni-Suef
      • Banī Suwayf, Beni-Suef, Egypt, 62814
        • Recruiting
        • Beni-Suef University Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Rib fracture score of more than 7
  • Patient with isolated multiple rib fractures, ●American Society of Anesthesiologists classification of physical status < IV
  • Body mass index (BMI) ≤ 35.

Exclusion Criteria:

  • Refusal of the patient
  • Trauma survey include multiple injuries including head injuries, visceral and long bone fractures
  • Intubated patients
  • Known hypersensitivity to any study medication, ●Chronic opioid use or chronic pain patient, ●Hemodynamic instability
  • Haemothorax or pneumothorax.

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: US-guided SAP block group
Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.
Procedure: Ultrasound-guided continuous serratus anterior plane block
Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.
Other Names:
  • Group S
Active Comparator: Dexmedetomidine group
Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.
Drug: intravenous dexmedetomidine infusion
Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.
Other Names:
  • Group D

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of analgesia measured by visual analogue scale
Time Frame: The first 48 hours.
rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.
The first 48 hours.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sedation score
Time Frame: Every 8 hours for 48 hours
Ramsay score was used to evaluate sedation. Score 1 represents agitated and uncomfortable patient. Score 2 represents cooperative and orientated patient. Score 3 represents a patient who can follow simple directions. Score 4 represents an asleep patient with a strong response to stimulation. Score 5 represents an asleep patient with a slow response to stimulation. Score 6 represents an asleep patient with no response to stimulation.
Every 8 hours for 48 hours
parameters of adequate ventilation and oxygenation
Time Frame: at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.
PaO2/FiO2 ratio and PaCO2 will be recorded
at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beni-Suef University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dina M Fakhry, MD, Beni-Suef University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMBSUREC/09072023/Fakhry

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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