Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.

January 10, 2023 updated by: Osama Rehab, Tanta University

Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block For Analgesia in Multiple Traumatic Rib Fractures.

The aim of this study is to compare the analgesic efficacy of ultrasound guided continuous SAP block and ultrasound guided continuous TPVB in patients with multiple traumatic rib fractures.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
70

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.
  • 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 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
    • ElGharbiaa
      • Tanta, ElGharbiaa, Egypt, 31527
        • Tanta University Hospitals

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

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of either gender aged between 22-65 years with unilateral traumatic multiple fracture ribs (≥ 3 fractured ribs).

Exclusion Criteria:

  • • Contraindications to regional block such as patient's refusal, coagulopathy, local infection at the site of the block, known allergy to local anesthetic drugs and spinal deformity.

    • Patients suffer from severe cardiovascular disease, hepatic or renal disease and patients with history of psychiatric illness.
    • Patients had indications for mechanical ventilation on admission or during the study period.
    • Patients had indications for immediate surgery for other associated injuries.
    • Patients with hemodynamic instability.
    • Patients having spine or pelvic fracture, traumatic brain injury, altered conscious level or spinal cord injury.

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: None (Open Label)

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.
Experimental: Thoracic paravertebral block
Patients will receive ultrasound-guided continuous thoracic paravertebral blockusing bupivacaine 0.25% for 4 days.
Procedure: Thoracic paravertebral block
A bolus dose of 0.25% bupivacaine (0.3 ml/kg) will be injected slowly over 3-5 minutes. At 30 minutes after injection of the loading dose, the dermatomal loss of sensation to pinprick was tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion will be continued for 4 days.
Experimental: Serratus anterior plane block
Patients will receive ultrasound-guided continuous SAP block using bupivacaine 0.25% for 4 days.
Procedure: Serratus anterior plane block
A bolus of 30 ml of 0.25% bupivacaine will be injected slowly over 3-5 minutes between latissmus dorsi muscle and serratus anterior muscle (Figure 15). Then a catheter was inserted through the Tuohy needle and advanced 3cm into the space and secured in place. At 30 minutes after injection of a loading dose, the dermatomal loss of sensation to pinprick will be tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion was continued for 4 days.

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
Degree of pain scores
Time Frame: Four days after the block
Pain will be assessed at rest and on coughing using the VAS on a scale from 0 (no pain) to 100 (worst pain) before the block, 30 minutes, 60 minutes after the block, and then every six hours for 4 days. But in order not to interrupt the sleeping pattern of patients, patients will be considered pain free (VAS= 0) if they will be at sleep with no tachypnea, tachycardia, or hypertension.
Four days after the block

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
Total consumption of morphine
Time Frame: Four days after the block
Rescue analgesia will be provided with morphine (0.05 mg/kg) intravenously if visual analogue score (VAS) ≥ 40.
Four days after the block
Changes of forced vital capacity (FVC)
Time Frame: Four days after the block
Forced vital capacity (FVC) will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days
Four days after the block
Changes of forced expiratory volume in one second (FEV1)
Time Frame: Four days after the block
Forced expiratory volume in one second (FEV1) will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days
Four days after the block
Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)
Time Frame: Four days after the block
FEV1/FVC ratio will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days
Four days after the block
Length of ICU stay
Time Frame: Four days after the block
Length of ICU stay, defined as the time from admission to ICU to time of transfer to the surgical ward.
Four days after the block
Length of hospital stay
Time Frame: Four days after the block
Four days after the block
Incidence of complications
Time Frame: Four days after the block
Incidence of respiratory complications and mechanical ventilation
Four days after the block

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.
Tanta 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.
January 16, 2021

Primary Completion (Actual)

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.
April 25, 2021

Study Completion (Actual)

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.
April 30, 2021

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).
January 11, 2021

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.
January 13, 2021

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.
January 15, 2021

Study Record Updates

Last Update Posted (Estimate)

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.
January 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.
January 10, 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.
January 1, 2023

More Information

Terms related to this study

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.
  • 32596/09/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be available upon a reasonable request.

IPD Sharing Time Frame

After 3 months from the end of study and for one year

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

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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