Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs
Comparative Study of Magnesium Sulfate Versus Fentanyl as Adjuvants to Bupivacaine for Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedJuly 23, 2018
July 1, 2018
1 year
July 1, 2018
July 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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)
48 hours
Secondary Outcomes (5)
Development of pulmonary complications: respiratory rate by breath per minute (need for mechanical ventilation)
48 hours
Assessment of parameters of adequate ventilation and oxygenation: PaO2/FIO2 ratio
48 hours
Assessment of parameters of adequate ventilation and oxygenation: PaCO2 in mmHg
48 hours
Changes in heart rate (HR) by beats per minute
48 hours
changes in arterial blood pressure (ABP) by mmHg
48 hours
Study Arms (3)
Group I
ACTIVE COMPARATOR20 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
Group II
ACTIVE COMPARATOR20 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
Group III
ACTIVE COMPARATOR20 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
Interventions
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 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.
All patients will receive mid-thoracic epidural analgesia
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
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.
PMID: 24368355BACKGROUNDDehghan 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.
PMID: 24458051BACKGROUNDFlagel 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.
PMID: 16269301BACKGROUNDZiegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
PMID: 7996614BACKGROUNDWu 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.
PMID: 10498316BACKGROUNDMackersie 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.
PMID: 1902264BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 1, 2018
First Posted
July 23, 2018
Study Start
July 1, 2018
Primary Completion
July 1, 2019
Study Completion
August 1, 2019
Last Updated
July 23, 2018
Record last verified: 2018-07