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Erector Spinae Plane Block Versus Thoracic Epidural Block for Chest Trauma

Primary Purpose

Chest Trauma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ESP block
TEA
Catheter insertion
Bupivacaine
Sponsored by
Sameh Fathy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Trauma focused on measuring Erector spinae plane block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) status: 1 or 2 .
  • Blunt chest trauma.
  • Multiple rib fractures.
  • Flail chest.
  • Lung contusions.

Exclusion Criteria:

  • Bilateral chest trauma.
  • Intubated patients.
  • Other peripheral or abdominal injuries.
  • Traumatic brain injury, altered mental status or un-cooperative patients.
  • Acute spine fractures or pre-existing spine deformity.
  • Unstable hemodynamics.
  • Sensitivity to local anesthetic drugs.
  • Coagulation abnormalities.
  • Infection at the site of procedure.
  • Significant cardiac or respiratory dysfunction, hepatic or renal impairment.

Sites / Locations

  • Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A (ESP block)

Group B (TEA)

Arm Description

Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

Outcomes

Primary Outcome Measures

Improvement in pain scores by Visual analogue scale (VAS)
VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed every two hours for 48 hours after the procedure.

Secondary Outcome Measures

Total analgesic requirements of fentanyl
The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 48 hours.
First analgesic request
The time of the first analgesic request for fentanyl will be recorded.
Changes in heart rate (HR)
HR will be recorded every two hours for 48 hours after the procedure.
Changes in mean arterial blood pressure (MAP)
MAP will be recorded every two hours for 48 hours after the procedure.
Improvement in forced expiratory volume in one second (FEV1)
FEV1 will be assessed by spirometry before and 48 hours after the procedure.
Improvement in forced vital capacity (FVC)
FVC will be assessed by spirometry before and 48 hours after the procedure.
Improvement in forced expiratory flow (FEF 25-75%)
FEF 25-75% will be assessed by spirometry before and 48 hours after the procedure.
Improvement in the level of tumor necrosis factor alpha (TNF-α)
TNF-α will be measured before, 24, 48 hours after the procedure.
Improvement in the level of interleukin 6 (IL-6)
IL-6 will be measured before, 24, 48 hours after the procedure.
Incidence of adverse effects
Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, hematoma, or allergic reactions will be recorded.

Full Information

First Posted
January 2, 2019
Last Updated
June 8, 2021
Sponsor
Sameh Fathy
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1. Study Identification

Unique Protocol Identification Number
NCT03797079
Brief Title
Erector Spinae Plane Block Versus Thoracic Epidural Block for Chest Trauma
Official Title
Erector Spinae Plane Block Versus Thoracic Epidural Block as Analgesic Techniques for Chest Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sameh Fathy

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
Rib fractures are very common as a consequence of blunt chest trauma which is associated with severe pain, morbidity and mortality. The key to managing these patients is prompt and effective analgesia, early mobilization, respiratory support, with chest physiotherapy. The aim of this study is to compare and evaluate the differences between either continuous erector spinae plane (ESP) block, or thoracic epidural analgesia (TEA) as analgesic modalities in patients with chest trauma. It is hypothesized that ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer side effects.
Detailed Description
Trauma is a major cause of morbidity and mortality worldwide as a leading cause of death. Rib fractures are very common and are detected in at least 10% of all injured patients, the majority of which are as a consequence of blunt chest trauma. Chest trauma are associated with severe pain, morbidity and mortality, as it contributes to atelectasis, lobar collapse, pneumonia, effusion, aspiration, acute respiratory distress syndrome pulmonary embolism, increased intensive care admissions, and poor overall clinical outcomes. Trauma is associated with release of cytokines, which contribute to the development of hemodynamic instability and metabolic derangement, which can worsen prognosis. The efficacy of utilizing different modalities for analgesia in controlling extent of tissue damage can be compared by measuring these cytokines levels. Multiple analgesic modalities have been used in these patients with chest trauma, such as oral analgesics, intravenous opioids, patient-controlled opioid analgesia, inter-pleural blocks, intercostal blocks, serratus plane blocks, paravertebral blocks, and TEA. In trauma patients with rib fractures, retrospective studies showed that TEA has become the gold standard of care, while ultrasound-guided paravertebral and serratus plane blocks are possible alternatives. However, no single best analgesic modality could be recommended or established, based on available data in this population, as no meta-analysis on this topic has yet been completed. Ultrasound has been the fundamental tool for a significant improvement in the progress of regional analgesic techniques of inter-fascial chest wall blocks, allowing their description and introduction into clinical practice. Ultrasound-guided ESP block is a new technique that has been recently described in the control of both chronic neuropathic pain as well as acute postsurgical or post-traumatic pain of the chest wall. The ESP block holds promise as a simple, easy, fast and safe technique for thoracic analgesia in the context of pain associated with chest trauma. Aim of the Study: The aim of this study is to assess the quality of pain relief and improvement of pulmonary function in patients with chest trauma receiving either continuous ESP block or TEA by comparing and evaluating the differences between the two techniques. It is hypothesized that ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer side effects. Sample Size Calculation: The literature available on ESP block is limited to some sporadic case reports and editorials. Hence, this clinical trial will be conducted on 50 patients and post hoc analysis will be performed using pain scores obtained from the present study with an α (type I error) = 0.05 and β (type II error) = 0.2 (power = 80%). Methods: The study will be conducted in Mansoura Emergency Hospital on fifty patients admitted with chest trauma. They will be randomly assigned to two equal groups (ESP group and TEA group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent. Patient demographic data including age, sex, body weight, and status of American Society of Anesthesiologists (ASA) will be recorded. A written informed consent will be obtained from all study subjects after ensuring confidentiality. The study protocol will be explained to all patients after enrollment into the study. In both groups, catheter-based analgesia will be performed with a bolus dose of bupivacaine followed by a continuous infusion for 48 hours. Later on, the catheters will be removed, and the pain management will be switched to parental or oral analgesics. Statistical Methods: The collected data will be coded, processed, and analyzed using Statistical Package for the Social Sciences (SPSS) program (version 22) for Windows. Normality of numerical data distribution will be tested by Shapiro-Wilk test. Continuous data of normal distribution will be presented as mean ± standard deviation, and compared with the unpaired student's t test. Non-normally distributed data will be presented as median (range), and compared with the Mann-Whitney U test. Repeated measures analysis of variance (ANOVA) test will be used for comparisons within the same group. Categorical data will be presented as number (percentage), and compared with the Chi-square test. All data will be considered statistically significant if P value is ≤ 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Trauma
Keywords
Erector spinae plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double blind study
Masking
ParticipantOutcomes Assessor
Masking Description
The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (ESP block)
Arm Type
Active Comparator
Arm Description
Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.
Arm Title
Group B (TEA)
Arm Type
Active Comparator
Arm Description
TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.
Intervention Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
A high-frequency linear ultrasound probe will be placed superficial to erector spinae muscle (ESM) in a parasagittal plane 3 cm lateral to the midline at the level of fifth thoracic vertebra. Three muscles will be identified superficial to the hyperechoic transverse process shadow: trapezius (uppermost), rhomboids major (middle), and ESM (lowermost). After local infiltration of skin and using in-plane approach, an 18 G Tuohy needle will be inserted, until the tip lay between the rhomboid major muscle and ESM.
Intervention Type
Procedure
Intervention Name(s)
TEA
Intervention Description
Skin will be locally infiltrated at the site of needle insertion, and 18 G Tuohy needle will be introduced until its tip lay in the epidural space of the T5-T6 thoracic intervertebral space.
Intervention Type
Device
Intervention Name(s)
Catheter insertion
Intervention Description
After obtaining loss of resistance, 20 G epidural catheter will be threaded for 5 cm and then fixed on the skin.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
After the negative aspiration for blood, a bolus dose of 15 ml 0.125% plain bupivacaine will be injected in the catheter, followed by a continuous infusion of 0.25% plain bupivacaine at the rate of 0.1 ml/kg/h for 48 hours
Primary Outcome Measure Information:
Title
Improvement in pain scores by Visual analogue scale (VAS)
Description
VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed every two hours for 48 hours after the procedure.
Time Frame
Up to 48 hours after the procedure
Secondary Outcome Measure Information:
Title
Total analgesic requirements of fentanyl
Description
The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 48 hours.
Time Frame
Up to 48 hours after the procedure
Title
First analgesic request
Description
The time of the first analgesic request for fentanyl will be recorded.
Time Frame
Up to 48 hours after the procedure
Title
Changes in heart rate (HR)
Description
HR will be recorded every two hours for 48 hours after the procedure.
Time Frame
Up to 48 hours after the procedure
Title
Changes in mean arterial blood pressure (MAP)
Description
MAP will be recorded every two hours for 48 hours after the procedure.
Time Frame
Up to 48 hours after the procedure
Title
Improvement in forced expiratory volume in one second (FEV1)
Description
FEV1 will be assessed by spirometry before and 48 hours after the procedure.
Time Frame
Up to 48 hours after the procedure
Title
Improvement in forced vital capacity (FVC)
Description
FVC will be assessed by spirometry before and 48 hours after the procedure.
Time Frame
Up to 48 hours after the procedure
Title
Improvement in forced expiratory flow (FEF 25-75%)
Description
FEF 25-75% will be assessed by spirometry before and 48 hours after the procedure.
Time Frame
Up to 48 hours after the procedure
Title
Improvement in the level of tumor necrosis factor alpha (TNF-α)
Description
TNF-α will be measured before, 24, 48 hours after the procedure.
Time Frame
Up to 48 hours after the procedure
Title
Improvement in the level of interleukin 6 (IL-6)
Description
IL-6 will be measured before, 24, 48 hours after the procedure.
Time Frame
Up to 48 hours after the procedure
Title
Incidence of adverse effects
Description
Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, hematoma, or allergic reactions will be recorded.
Time Frame
Up to 48 hours after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) status: 1 or 2 . Blunt chest trauma. Multiple rib fractures. Flail chest. Lung contusions. Exclusion Criteria: Bilateral chest trauma. Intubated patients. Other peripheral or abdominal injuries. Traumatic brain injury, altered mental status or un-cooperative patients. Acute spine fractures or pre-existing spine deformity. Unstable hemodynamics. Sensitivity to local anesthetic drugs. Coagulation abnormalities. Infection at the site of procedure. Significant cardiac or respiratory dysfunction, hepatic or renal impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh M El-Sherbiny, MD
Organizational Affiliation
Faculty of Medicine, Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
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
27533913
Citation
Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.
Results Reference
background
PubMed Identifier
30052229
Citation
Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
Results Reference
background
PubMed Identifier
28924315
Citation
Singh S, Jacob M, Hasnain S, Krishnakumar M. Comparison between continuous thoracic epidural block and continuous thoracic paravertebral block in the management of thoracic trauma. Med J Armed Forces India. 2017 Apr;73(2):146-151. doi: 10.1016/j.mjafi.2016.11.005. Epub 2016 Dec 24.
Results Reference
background
PubMed Identifier
29102405
Citation
Veiga M, Costa D, Brazao I. Erector spinae plane block for radical mastectomy: A new indication? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):112-115. doi: 10.1016/j.redar.2017.08.004. Epub 2017 Nov 2. English, Spanish.
Results Reference
background
PubMed Identifier
29766081
Citation
Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.
Results Reference
background
PubMed Identifier
22704784
Citation
Yeh DD, Kutcher ME, Knudson MM, Tang JF. Epidural analgesia for blunt thoracic injury--which patients benefit most? Injury. 2012 Oct;43(10):1667-71. doi: 10.1016/j.injury.2012.05.022. Epub 2012 Jun 16.
Results Reference
background

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Erector Spinae Plane Block Versus Thoracic Epidural Block for Chest Trauma

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