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Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

Primary Purpose

Thoracic Epidural Analgesia, Fracture Ribs

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupivacaine
Magnesium Sulfate
Fentanyl
Thoracic epidural
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Epidural Analgesia, Fracture Ribs

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients 16 years of age and greater
  2. Non-intubated at the time of block placement
  3. Traumatic Rib Fractures two or greater
  4. Block must be done within 12-24 hours of presentation to the emergency room
  5. ASA physical status: I-II

Exclusion Criteria:

  1. Patient refusal
  2. BMI more than 30 kg/m2
  3. Need for mechanical ventilation on admission
  4. Hemodynamic instability
  5. Haemothorax or Pneumothorax
  6. Contraindications of performing blocks as coagulopathy, vertebral column deformities, local infection
  7. Traumatic head injury
  8. Allergy to local anesthetic agents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group I

    Group II

    Group III

    Arm Description

    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125% bupivacaine, followed by continuous infusion of 8 ml/hour

    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml mixture of 0.125% bupivacaine and 30 mg/kg magnesium sulfate, followed by continuous infusion of 8 ml/hour of a mixture of 0.125% bupivacaine and 20% magnesium sulfate

    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125 bupivacaine and 2 mcg/ml fentanyl, followed by continuous infusion of 8 ml/hour

    Outcomes

    Primary Outcome Measures

    Difference in Pain Scores (Visual Analogue pain scale)
    Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal or vertical scale usually 10 cm or 100 mm length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale]. The pain visual analog scale is self completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. After the patient has marked, using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark. The scores can be from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain, the following cut points on the pain VAS have been recommended: No pain (0 -4 mm) Mild pain (5-44 mm) Moderate pain (45-74 mm) Severe pain (75-100 mm)

    Secondary Outcome Measures

    Development of pulmonary complications: respiratory rate by breath per minute (need for mechanical ventilation)
    By observing respiratory rate of patients using clinical assessment every 1 hour
    Assessment of parameters of adequate ventilation and oxygenation: PaO2/FIO2 ratio
    by measuring O2 level in the blood using arterial blood gases every 3 hours
    Assessment of parameters of adequate ventilation and oxygenation: PaCO2 in mmHg
    by measuring CO2 level in the blood using arterial blood gases every 3 hours
    Changes in heart rate (HR) by beats per minute
    By monitoring patients heart rate every 1 hour
    changes in arterial blood pressure (ABP) by mmHg
    By monitoring patients arterial blood pressure using non invasive arterial blood pressure monitoring every 1 hour

    Full Information

    First Posted
    July 1, 2018
    Last Updated
    July 12, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03595397
    Brief Title
    Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs
    Official Title
    Comparative Study of Magnesium Sulfate Versus Fentanyl as Adjuvants to Bupivacaine for Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    August 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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
    This work aims at comparing the analgesic effect of Thoracic Epidural Magnesium sulfate versus Fentanyl when added as adjuvants to Bupivacaine in patients with multiple traumatic fracture ribs.
    Detailed Description
    Rib fractures are a common condition following trauma with a reported incidence of up to 10% in trauma in general, and up to 39% in blunt chest trauma. Traumatic rib fractures are associated with significant morbidity and mortality, and mortality rates reaching 10-16% has been reported. An estimated one third of patients with traumatic rib fractures develop secondary pulmonary complications with an associated mortality rate as high as 65% . Pain is recognized as a contributing factor to adverse outcome in traumatic rib fractures due to pain-induced inadequate respiratory efforts leading to atelectasis, difficulties in clearing secretions and an increased risk of developing pneumonia. Consequently, adequate analgesia is considered a core intervention in the management of patients with traumatic rib fractures. There are a variety of ways to manage a patient's pain. Oral analgesic drugs and regional modes are more likely to be used . Regional analgesia is often supplemented with a small dose of either NSAIDs or opioids and pain reduction is typically strong and immediate. There is little sedation, so evaluation of head and abdominal injuries is easier. A major disadvantage is the technical complexity of the procedures, leading to occasional errors in the administering of the treatments. They can also be painful while the needle is entering (or catheter is being installed), toxicity is a possibility, and the patients require more intensive monitoring and care by the physicians and nurses. There are a variety of modes; the four most common are TEA, thoracic paravertebral block, intercostal block, and intrapleural block. This study focuses on thoracic epidural analgesia. Narcotic infusions and continuous local anesthetic can be delivered through thoracic or lumbar epidural catheters. Opioid receptors exist in the spinal cord that can alter the perception of pain without needing stimulation of receptors in the brain. After inserting the catheter into this area, local anesthetics and narcotics are administered, blocking the anterior and posterior nerve roots crossing this space. The anesthetic/analgesic agents diffuse across the dura and begin to block sensory nerves. Motor nerves are affected to a lesser degree. It takes a large dose to achieve the desired effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thoracic Epidural Analgesia, Fracture Ribs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I
    Arm Type
    Active Comparator
    Arm Description
    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125% bupivacaine, followed by continuous infusion of 8 ml/hour
    Arm Title
    Group II
    Arm Type
    Active Comparator
    Arm Description
    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml mixture of 0.125% bupivacaine and 30 mg/kg magnesium sulfate, followed by continuous infusion of 8 ml/hour of a mixture of 0.125% bupivacaine and 20% magnesium sulfate
    Arm Title
    Group III
    Arm Type
    Active Comparator
    Arm Description
    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125 bupivacaine and 2 mcg/ml fentanyl, followed by continuous infusion of 8 ml/hour
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Description
    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125% bupivacaine, followed by continuous infusion of 8 ml/hour
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium Sulfate
    Other Intervention Name(s)
    bupivacaine
    Intervention Description
    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml mixture of 0.125% bupivacaine and 30 mg/kg Magnesium Sulfate, followed by continuous infusion of 8 ml/hour mixture of 0.125% bupivacaine and 20% Magnesium sulfate
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Other Intervention Name(s)
    bupivacaine
    Intervention Description
    20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125 bupivacaine and 2 mcg/ml fentanyl, followed by continuous infusion of 8 ml/hour.
    Intervention Type
    Procedure
    Intervention Name(s)
    Thoracic epidural
    Intervention Description
    All patients will receive mid-thoracic epidural analgesia
    Primary Outcome Measure Information:
    Title
    Difference in Pain Scores (Visual Analogue pain scale)
    Description
    Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal or vertical scale usually 10 cm or 100 mm length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale]. The pain visual analog scale is self completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. After the patient has marked, using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark. The scores can be from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain, the following cut points on the pain VAS have been recommended: No pain (0 -4 mm) Mild pain (5-44 mm) Moderate pain (45-74 mm) Severe pain (75-100 mm)
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Development of pulmonary complications: respiratory rate by breath per minute (need for mechanical ventilation)
    Description
    By observing respiratory rate of patients using clinical assessment every 1 hour
    Time Frame
    48 hours
    Title
    Assessment of parameters of adequate ventilation and oxygenation: PaO2/FIO2 ratio
    Description
    by measuring O2 level in the blood using arterial blood gases every 3 hours
    Time Frame
    48 hours
    Title
    Assessment of parameters of adequate ventilation and oxygenation: PaCO2 in mmHg
    Description
    by measuring CO2 level in the blood using arterial blood gases every 3 hours
    Time Frame
    48 hours
    Title
    Changes in heart rate (HR) by beats per minute
    Description
    By monitoring patients heart rate every 1 hour
    Time Frame
    48 hours
    Title
    changes in arterial blood pressure (ABP) by mmHg
    Description
    By monitoring patients arterial blood pressure using non invasive arterial blood pressure monitoring every 1 hour
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 16 years of age and greater Non-intubated at the time of block placement Traumatic Rib Fractures two or greater Block must be done within 12-24 hours of presentation to the emergency room ASA physical status: I-II Exclusion Criteria: Patient refusal BMI more than 30 kg/m2 Need for mechanical ventilation on admission Hemodynamic instability Haemothorax or Pneumothorax Contraindications of performing blocks as coagulopathy, vertebral column deformities, local infection Traumatic head injury Allergy to local anesthetic agents
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed K Fathy, resident
    Phone
    00201117012741
    Email
    king009009@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emad Z Kamel, Lecturer
    Phone
    00201007046058
    Email
    emadzarief@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    24368355
    Citation
    Gage A, Rivara F, Wang J, Jurkovich GJ, Arbabi S. The effect of epidural placement in patients after blunt thoracic trauma. J Trauma Acute Care Surg. 2014 Jan;76(1):39-45; discussion 45-6. doi: 10.1097/TA.0b013e3182ab1b08.
    Results Reference
    background
    PubMed Identifier
    24458051
    Citation
    Dehghan N, de Mestral C, McKee MD, Schemitsch EH, Nathens A. Flail chest injuries: a review of outcomes and treatment practices from the National Trauma Data Bank. J Trauma Acute Care Surg. 2014 Feb;76(2):462-8. doi: 10.1097/TA.0000000000000086.
    Results Reference
    background
    PubMed Identifier
    16269301
    Citation
    Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
    Results Reference
    background
    PubMed Identifier
    7996614
    Citation
    Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
    Results Reference
    background
    PubMed Identifier
    10498316
    Citation
    Wu CL, Jani ND, Perkins FM, Barquist E. Thoracic epidural analgesia versus intravenous patient-controlled analgesia for the treatment of rib fracture pain after motor vehicle crash. J Trauma. 1999 Sep;47(3):564-7. doi: 10.1097/00005373-199909000-00025.
    Results Reference
    background
    PubMed Identifier
    1902264
    Citation
    Mackersie RC, Karagianes TG, Hoyt DB, Davis JW. Prospective evaluation of epidural and intravenous administration of fentanyl for pain control and restoration of ventilatory function following multiple rib fractures. J Trauma. 1991 Apr;31(4):443-9; discussion 449-51.
    Results Reference
    background

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    Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

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