Erector Spinae Plane Block Versus Thoracic Epidural Block for Chest Trauma
Condition: Chest Trauma
MeSH terms: Wounds and Injuries; Thoracic Injuries
Study type: Interventional

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.
    

Intervention name(s): ESP block; TEA; Catheter insertion; Bupivacaine
Intervention type(s): Procedure; Procedure; Device; Drug
Intervention description(s): 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.; 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.; After obtaining loss of resistance, 20 G epidural catheter will be threaded for 5 cm and then fixed on the skin.; 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
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, double blind study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erector spinae plane block