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Chest TraumaNCT03797079

Erector Spinae Plane Block Versus Thoracic Epidural Block for Chest Trauma

A study testing ESP block, TEA and Catheter insertion in people with Chest Trauma, run by Sameh Fathy at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chest Trauma
What is being tested?
ESP block, TEA and Catheter insertion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
20 Jan 2019to 20 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 10Show fewer
  • Sensitivity to local anesthetic drugs.
  • Coagulation abnormalities.
  • Infection at the site of procedure.
  • Significant cardiac or respiratory dysfunction, hepatic or renal impairment.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansoura University Hospitals

    Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

Official title: Erector Spinae Plane Block Versus Thoracic Epidural Block as Analgesic Techniques for Chest Trauma

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.

Read the 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.

Conditions
Chest Trauma
Being tested
ESP block, TEA, Catheter insertion, Bupivacaine
Keywords
Erector spinae plane block
Medical subject headings
Thoracic Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESP blockProcedure or surgery

    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.

  • TEAProcedure or surgery

    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.

  • Catheter insertionDevice

    After obtaining loss of resistance, 20 G epidural catheter will be threaded for 5 cm and then fixed on the skin.

  • BupivacaineDrug

    Also called Marcaine

    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

Study groups in NCT03797079
Study groupRoleWhat they receive
Group A (ESP block)Active comparatorUltrasound-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.
Receives: Procedure: ESP block; Device: Catheter insertion; Drug: Bupivacaine
Group B (TEA)Active comparatorTEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.
Receives: Procedure: TEA; Device: Catheter insertion; Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 48 hours after the procedure

Secondary outcomes (10)
  1. 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.

    Measured: Up to 48 hours after the procedure

  2. First analgesic request

    The time of the first analgesic request for fentanyl will be recorded.

    Measured: Up to 48 hours after the procedure

  3. Changes in heart rate (HR)

    HR will be recorded every two hours for 48 hours after the procedure.

    Measured: Up to 48 hours after the procedure

  4. Changes in mean arterial blood pressure (MAP)

    MAP will be recorded every two hours for 48 hours after the procedure.

    Measured: Up to 48 hours after the procedure

  5. Improvement in forced expiratory volume in one second (FEV1)

    FEV1 will be assessed by spirometry before and 48 hours after the procedure.

    Measured: Up to 48 hours after the procedure

  6. Improvement in forced vital capacity (FVC)

    FVC will be assessed by spirometry before and 48 hours after the procedure.

    Measured: Up to 48 hours after the procedure

  7. Improvement in forced expiratory flow (FEF 25-75%)

    FEF 25-75% will be assessed by spirometry before and 48 hours after the procedure.

    Measured: Up to 48 hours after the procedure

  8. Improvement in the level of tumor necrosis factor alpha (TNF-α)

    TNF-α will be measured before, 24, 48 hours after the procedure.

    Measured: Up to 48 hours after the procedure

  9. Improvement in the level of interleukin 6 (IL-6)

    IL-6 will be measured before, 24, 48 hours after the procedure.

    Measured: Up to 48 hours after the procedure

  10. Incidence of adverse effects

    Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, hematoma, or allergic reactions will be recorded.

    Measured: Up to 48 hours after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2019
  2. Study start20 Jan 2019
  3. Primary completion20 Feb 2020
  4. Study completion20 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, double blind study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03797079
Sponsor's protocol ID
ESP Block for Chest Trauma
Status last verified
Jun 2021
First submitted
2 Jan 2019
Last updated
10 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27501016
  • 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.

    PubMed 24368355
  • 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.

    PubMed 27533913
  • 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.

    PubMed 30052229
  • 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.

    PubMed 28924315
  • 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.

    PubMed 29102405
  • 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.

    PubMed 29766081
  • 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.

    PubMed 22704784

Questions about this trial

What is this clinical trial studying?

A study testing ESP block, TEA and Catheter insertion in people with Chest Trauma, run by Sameh Fathy at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in pain scores by Visual analogue scale (VAS) (time frame: Up to 48 hours after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03797079, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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