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

Primary Purpose

Pain

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound-guided continuous serratus anterior plane block
intravenous dexmedetomidine infusion
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Serratus anterior, Dexmedetomidine, Rib, Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beni-Suef University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

US-guided SAP block group

Dexmedetomidine group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of analgesia measured by visual analogue scale
rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.

Secondary Outcome Measures

parameters of adequate ventilation and oxygenation
PaO2/FiO2 ratio and PaCO2 will be recorded
Sedation score
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.

Full Information

First Posted
July 20, 2023
Last Updated
October 9, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05965895
Brief Title
Ultrasound-Guided Continuous Serratus Anterior Plane Block vs Dexmedetomidine Infusion in Patients With Rib Fractures.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Serratus anterior, Dexmedetomidine, Rib, Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
US-guided SAP block group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dexmedetomidine group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided continuous serratus anterior plane block
Other Intervention Name(s)
Group S
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
intravenous dexmedetomidine infusion
Other Intervention Name(s)
Group D
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of analgesia measured by visual analogue scale
Description
rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.
Time Frame
The first 48 hours.
Secondary Outcome Measure Information:
Title
parameters of adequate ventilation and oxygenation
Description
PaO2/FiO2 ratio and PaCO2 will be recorded
Time Frame
at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.
Title
Sedation score
Description
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.
Time Frame
Every 8 hours for 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina M Fakhry, MD
Phone
+201289998680
Email
dina_fakhry_91@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina M Fakhry, MD
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-Suef University hospital
City
Banī Suwayf
State/Province
Beni-Suef
ZIP/Postal Code
62814
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina M Fakhry, MD
Phone
+201289998680
Email
dina_fakhry_91@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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