Lumbar Epidural Analgesia With Bilateral Erector Spinae Block for Pain Management in Lumbar Spine Surgery
Condition: Perioperative Pain
Study type: Interventional

Summary: 
      Surgical procedures on the spine and spinal cord are common and are performed for a wide
      variety of diseases. They range from minimally invasive, single-level decompression to highly
      complex, multi-stage extensive reconstruction. Operative procedures for degenerative spine
      diseases and herniated discs are most common in those under 60 years of age. While those over
      60 years of age most commonly undergo spine surgery for spinal stenosis

      Patients undergoing spine surgery experience severe pain in the postoperative period. Recent
      studies show that the incidence of acute postoperative pain following spine surgery vary from
      30 to 64%. Postoperative pain may also increase morbidity and incidence of complications and
      prolong postoperative rehabilitation. In addition, it is a risk factor for development of
      chronic pain syndromes

      Postoperative pain is usually treated with oral or intravenous opioids in combination with
      non-steroidal anti-inflammatory drugs. However, they often results in insufficient pain
      control and side effects such as respiratory depression, nausea, and vomiting.

      Epidural anaesthesia and analgesia have been shown to be superior to intravenous analgesia.
      The former is better with respect to pain quality, incidence of side effects, pulmonary,
      cardiac, and gastrointestinal dysfunction. However, it may be associated with hemodynamic
      instability. Migration of the epidural catheter with unpredictable absorption of the local
      anaesthetics remains a challenge to the anaesthetists. The Erector Spinae block proved to be
      efficient in controlling post-operative pain. It is a simple interfascial plane block,
      published in 2016. It provides effective analgesia for 24 hours in patients undergoing lumbar
      spine surgery.

      Therefore, a prospective, randomized study was designed to compare the analgesic and side
      effects of the epidural analgesia with the Erector Spinae block in patients undergoing lumbar
      spine surgery. To our knowledge, this is the first clinical trial that compares the Erector
      Spinae block with the epidural analgesia in a variety of lumbar spine surgeries.
    

Detailed description: 
      History will be taken from all patients. Age and then American Society of Anaesthesiologists'
      (ASA) score will be recorded.

      Preoperatively patients' pain score, laboratory investigations as complete blood picture,
      coagulation profile, liver and renal functions will be recorded. General examination will be
      carried out with examination of the back to exclude infection at the injection site and
      anatomical deformities.

      Baseline vital signs will be recorded including non-invasive measurement of systolic, mean,
      diastolic arterial pressures, and heart rate and oxygen saturation.

      After inserting an intravenous (IV) access, the patient will be pre-medicated with midazolam
      in a dose 0.1 mg/kg and metoclopramide in a dose 0.1-0.2 mg/kg.

      Upon arrival to the operating room, appropriate monitors (continuous pulse oximetry,
      electrocardiography and non-invasive blood pressure) will be placed. Then, general
      anaesthesia will be induced. 1.5 μg/kg fentanyl and 2 mg/kg propofol will be given. Tracheal
      intubation will be facilitated with 0.5 mg/kg atracurium. Anaesthesia will be maintained
      using isoflurane in oxygen and air. Additional doses of 0.1 mg/kg atracurium will be
      administrated every 30 minutes. A urinary catheter will be placed for control of diuresis.
      the patient will receive either lumber epidural or erector spinae analgesia according to the
      group randomization.

      The surgical intervention will be then allowed 20 minutes after finishing the block
      procedure.

      Failed block is defined as increase in heart rate (HR) and mean arterial blood pressure
      (MABP)>20% from base line with skin incision. This will be treated by 1ug /kg of fentanyl as
      top-up doses and increasing isoflurane concentration in case of inadequate response to
      fentanyl.

      In case of decrease in MABP>20% from base line, the patient will receive a 500 ml ringer
      infusion with 5 mg ephedrine. If HR decrease to 45 beats/minute, atropine 0.5 mg will be
      given.

      postoperative nausea and vomiting will be managed with 0.1 mg/kg ondansetron
    

Intervention name(s): lumber epidural analgesia; erector spinae analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): the lumber epidural analgesia will be given after induction of general anesthesia.; the erector spinae analgesia will be given after induction of general anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention