Ultrasound Guided Serratus Plane Block Versus Thoracic Epidural for Post Thoracotomy Pain
Condition: Ultrasound Guided Serratus Plane Block; Thoracic Epidural; Post Thoracotomy Pain
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      This study aims at comparing the effect of serratus plane block versus thoracic epidural in
      patients undergoing thoracotomy for lung cancer surgery regarding pain control and possible
      side effects.
    

Detailed description: 
      Introduction:

      One of the most painful devastating surgical incisions is post-thoracotomy pain which can
      occur secondary to skin incision, damage to serratus anterior and intercostal muscles, rib
      retraction and injury of the intercostal nerves (1). It leads to pulmonary complications in
      the short term and chronic post-thoracotomy pain in the long term (2). The thoracic epidural
      is usually used as the reference analgesic approach for controlling thoracotomy pain (3) but
      it carries several risks and limitations (4). Serratus anterior plane block is performed by
      blocking the lateral cutaneous branches of the intercostal nerves (5) and can be a possible
      alternative to epidural block with lesser risks (6).

      Aim of the work This study aims at comparing the effect of serratus plane block versus
      thoracic epidural in patients undergoing thoracotomy for lung cancer surgery regarding pain
      control and possible side effects.

      Authors suggest that this technique is easy to perform, safe, effective with lesser side
      effects.

      Study Design A randomized controlled study. Methodology

      After approval of the institutional board ethical committee, written informed consent will be
      taken from the patients undergoing the study. Sixty patients between 20 to 60 years old
      undergoing thoracic surgery will be included in the study and randomly allocated into one of
      the two study groups:

      Group (I) 30 patients: will receive 10 mL bolus of levobupivacaine 0.25% 30 mint before skin
      incision followed by an infusion of 5 ml/hour of 0.125% levobupivacaine after surgery.

      Group (II) 30 patients: will receive 30 ml bolus of 0.25% levobupivacaine 30 mint before skin
      incision followed by an infusion of 5 ml/hour of 0.125% levobupivacaine after surgery.

      Interventions:

      Routine preoperative assessment will be conducted as standard (Complete blood count, liver,
      and kidney function tests, coagulation profile and chest x-ray) in addition to pulmonary
      function tests.

      Upon arrival to the holding area, all the patients will be monitored by standard monitoring
      (ECG, Pulse oximetry and non-invasive automated arterial blood pressure). Then all patients
      will be pre-medicated with midazolam (3-5 mg intravenous) after fixation of 20 G cannula.

      In group I: thoracic epidural inserted at a low thoracic level in sitting position then test
      dose will be administered to detect any complications, then a bolus of 10 ml of 0.25%
      levobupivacaine 30 mint before skin incision followed by an infusion of 5 ml/hour of 0.125%
      levobupivacaine after surgery.

      In group II: after induction of anesthesia and Patients will be placed in the lateral
      position with the diseased side up. A linear ultrasound transducer (10-12 MHz) will be placed
      over the mid-axillary region of the thoracic cage in a sagittal plane. The rib will be
      counted inferiorly and laterally until the fifth rib is identified in the mid-axillary line.
      The following muscles will be identified easily overlying the fifth rib: the latissimus dorsi
      (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior).
      The needle (22- G, 50 - mm Touhy needle) will be introduced in-plane with respect to the
      ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous
      ultrasound guidance a bolus of 30 ml of 0.25% levobupivacaine 30 mint before skin incision.
      At the end of the surgery, the surgeon will put the catheter deep to serratus muscle and get
      it out with chest tube and fix it followed by an infusion of 5 ml/hour of 0.125%
      levobupivacaine.

      Pain Management:

      Intraoperative: by bolus dose for both groups. To ensure adequate analgesia throughout the
      operation all patients will be closely observed and upon the appearance of signs of
      inadequate analgesia e.g. increase in heart rate or systolic blood pressure 20% above the
      baseline, fentanyl rescue doses of 0.5µ/kg will be supplemented and recorded.

      Postoperative: by continues infusion for both groups. All patients will have Intravenous
      paracetamol every 8 hours. Morphine 5mg intravenous will be given when the visual analogue
      scale (VAS) pain score becomes >3 as rescue analgesia.

      Sample size:

      The sample size was calculated based on the previous paper (7) estimating the difference in
      pain score at 24 h between 2 groups will be 2±2.1. Using power 80% and 5% significance level
      of 18 patients in each group will be sufficient to be able to reject the null hypothesis that
      the population means of the experimental and control groups are equal. This number is to be
      increased to 21 in each group to correct for non-parametric usage. Sample size calculation
      was achieved using Power and Sample Size Calculation Software Version 3.1.2 (Vanderbilt
      University, Nashville, Tennessee, USA).

      Statistical analysis:

      Data will be analyzed using Statistical Package for the Social Sciences (SPSS) win
      statistical package version 17. Parametric demographic data will be analyzed using student's
      t-test, Qualitative data will be compared using Chi-square test or Fisher's exact as
      appropriate. Numerical data will be described as mean and standard deviation (SD) or median
      and range as appropriate. While qualitative data will be described as frequency and
      percentage. P<0.05 will be considered statistically significant.
    

Intervention name(s): Serratus anterior block; thoracic epidural
Intervention type(s): Procedure; Procedure
Intervention description(s): after induction of anesthesia and Patients will be placed in the lateral position with the diseased side up. A linear ultrasound transducer (10-12 MHz) will be placed over the mid-axillary region of the thoracic cage in a sagittal plane. The rib will be counted inferiorly and laterally, until the fifth rib is identified in the mid-axillary line. The following muscles will be identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). The needle (22- G, 50 - mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance a bolus of 30 ml of 0.25% levobupivacaine 30 mint before skin incision. At the end of surgery, surgeon will put the catheter deep to serratus muscle and get it out with chest tube and fix it followed by an infusion of 5 ml/hour of 0.125% Levobupivacaine.; In group I: thoracic epidural inserted at low thoracic level in sitting position then test dose will be administered to detect any complications then a bolus of 10 ml of 0.25% levobupivacaine 30 mint before skin incision followed by an infusion of 5 ml/hour of 0.125% levobupivacaine after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment