Back to resultsUltrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.
Primary Purpose
Serratus Anterior Plane Block, Thoracic Paravertebral Block, Ultrasound
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic paravertebral block
Serratus anterior plane block
Sponsored by
About this trial
This is an interventional treatment trial for Serratus Anterior Plane Block
Eligibility Criteria
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.
Sites / Locations
- Tanta University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Thoracic paravertebral block
Serratus anterior plane block
Arm Description
Patients will receive ultrasound-guided continuous thoracic paravertebral blockusing bupivacaine 0.25% for 4 days.
Patients will receive ultrasound-guided continuous SAP block using bupivacaine 0.25% for 4 days.
Outcomes
Primary Outcome Measures
Degree of pain scores
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.
Secondary Outcome Measures
Total consumption of morphine
Rescue analgesia will be provided with morphine (0.05 mg/kg) intravenously if visual analogue score (VAS) ≥ 40.
Changes of forced vital capacity (FVC)
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
Changes of forced expiratory volume in one second (FEV1)
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
Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)
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
Length of ICU stay
Length of ICU stay, defined as the time from admission to ICU to time of transfer to the surgical ward.
Length of hospital stay
Incidence of complications
Incidence of respiratory complications and mechanical ventilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04710823
Brief Title
Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.
Official Title
Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block For Analgesia in Multiple Traumatic Rib Fractures.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2021 (Actual)
Primary Completion Date
April 25, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serratus Anterior Plane Block, Thoracic Paravertebral Block, Ultrasound, Multiple Traumatic Rib Fractures, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thoracic paravertebral block
Arm Type
Experimental
Arm Description
Patients will receive ultrasound-guided continuous thoracic paravertebral blockusing bupivacaine 0.25% for 4 days.
Arm Title
Serratus anterior plane block
Arm Type
Experimental
Arm Description
Patients will receive ultrasound-guided continuous SAP block using bupivacaine 0.25% for 4 days.
Intervention Type
Procedure
Intervention Name(s)
Thoracic paravertebral block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of pain scores
Description
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.
Time Frame
Four days after the block
Secondary Outcome Measure Information:
Title
Total consumption of morphine
Description
Rescue analgesia will be provided with morphine (0.05 mg/kg) intravenously if visual analogue score (VAS) ≥ 40.
Time Frame
Four days after the block
Title
Changes of forced vital capacity (FVC)
Description
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
Time Frame
Four days after the block
Title
Changes of forced expiratory volume in one second (FEV1)
Description
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
Time Frame
Four days after the block
Title
Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)
Description
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
Time Frame
Four days after the block
Title
Length of ICU stay
Description
Length of ICU stay, defined as the time from admission to ICU to time of transfer to the surgical ward.
Time Frame
Four days after the block
Title
Length of hospital stay
Time Frame
Four days after the block
Title
Incidence of complications
Description
Incidence of respiratory complications and mechanical ventilation
Time Frame
Four days after the block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
ElGharbiaa
ZIP/Postal Code
31527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.
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