Ultrasound Guided Bilateral Erector Spinae Block Versus Caudal in Lumbar Spine Surgeries
Condition: Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Major lumbar spine surgeries are associated with severe postoperative pain that usually lasts
      for at least 3 days.Caudal epidural analgesia has a crucial role in providing effective pain
      relief post lumbar spine surgeries by blocking sensory input at the level of the spinal cord.
      Erector Spinae Plane Block (ESPB) as a new technique of trunk fascia block was proposed in
      2016Reports showed that ESPB significantly relieved postoperative pain in patients with
      lumbosacral spine surgery, reducing the use of analgesics.

      The aim of this work is to evaluate the pre-emptive analgesic effect of Ultrasound guided
      bilateral erector spinae block Vs Caudal epidural analgesia in Lumbar spine surgeries during
      peri-operative period.

      Objectives:

        -  To assess the duration of analgesia in both groups and time to rescue analgesia .

        -  To assess Visual analogue scale (VAS) score in both groups.

        -  To assess complications of both groups
    

Detailed description: 
      This is a randomized controlled study designed to include 50 patients aged from 18 to 65
      years old undergoing lumbar spine surgeries.

      fifty patients meeting the inclusion criteria will be randomly assigned into two equal
      groups: Group A(n=25): caudal epidural group. Group B(n=25): bilateral ultrasound guided
      Erector spinae block group.

      All patients will be assessed clinically and investigated for exclusion of any of the above
      mentioned contraindications. Laboratory work needed will be: Complete blood count (CBC);
      prothrombin time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time
      (BT); clotting time (CT) , liver function tests and kidney function tests .

      ● Operating Room preparation & Equipment: The ultrasound used will be SonoSite M Turbo (USA),
      the scanning probe will be the linear multi-frequency 6-13 megahertz transducer (L25 x 6-13
      MHz linear array).

      Methods:

      General anaesthesia will be induced. 1.5 μg/kg fentanyl based on lean body weight with
      maximum dose of 200 μg and 2 mg/kg propofol will be given based on total body weight. (14)
      Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on ideal body weight.
      (15) . The surgical intervention will be then allowed 20 minutes after finishing the block
      procedure.

      Volume controlled ventilation will be adjusted to maintain normocapnia. Anesthesia will be
      maintained by using 1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top
      ups at a dose of 0.1mg/kg every 30 minutes.

      Patients will be placed in the prone position on a Relton Hall frame or padded bolsters.

      All participants will be given 1 gram of intravenous paracetamol with maximum dose of 4 gm
      every 24 hour, together with 4 mg ondansetron 10 min prior to the end of surgery for
      postoperative nausea and vomiting prophylaxis.

      Failed block (increase in Heart rate (HR) and mean arterial blood pressure (MABP)>20% from
      base line with skin incision) will be treated by 1 ug/kg of fentanyl as top-up doses and
      increasing isoflurane concentration in case of inadequate response to fentanyl.

      After skin closure, inhalational anesthesia will be discontinued and reversal of muscle
      relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered
      intravenous after return of patient's spontaneous breathing. Patients will then be
      transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and
      monitoring.

        -  At any time hypotension (defined as a decrease in mean arterial pressure (MAP) >25% from
           baseline value or systolic arterial pressure (SAP <100 mmHg)) will be treated with 5 mg
           IV bolus ephedrine and repeated every 3 minutes until the hypotension resolved.
           Bradycardia (defined as a HR <40 beats per minute) will be treated with atropine 0.5 mg
           IV.

        -  In group (A): Caudal Epidural Analgesia

        -  For the caudal block, the patient will be positioned in prone position, sterilized from
           the iliac crest margin to the lower buttock by betadine three times and will be covered
           by sterile drapes exposing the sacral area. Sacral horns will be palpated and sacral
           hiatus and epidural area will be determined at S4-S5 level through the ultrasound
           transducer that is covered in sterile plastic bag . Short axis (transverse) is used
           first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure
           "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An
           18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal
           membrane out of plane then the probe is rotated to long axis (longitudinal) and the
           needle is seen in plane in the epidural space. Injection of 30 ml 0.125% bupivacaine
           will expand the epidural space.

        -  In group (B): Bilateral Ultrasound guided Erector spinae group.

        -  The patient will be in the prone position, after skin sterilization, ESP block will be
           performed at the level of L3. a curvilinear high-frequency ultrasound transducer will be
           placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the
           transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle
           will be inserted in cranial to caudal direction toward TP in plane to the ultrasound
           transducer until the needle touches the TP crossing the whole muscles. The location of
           the needle tip will be confirmed by visible normal saline solution separating erector
           spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the
           needle site, 30 mL of 0.25% bupivacaine will be injected. The procedure will be repeated
           following the same steps on the other side.

        -  Rescue analgesia :

      Intra operative :0.5ug /kg of fentanyl as top-up doses at any time if blood pressure and
      heart rate increased by more than 20% from baseline reading .

      Post-operative : Nalbuphine (0.1 mg/kg) will be given if the pain score > 4/10 at the VAS
      assessment times or when the patient asks for supplementary analgesia due to an emerging pain
      in between the assessment points.
    

Intervention name(s): caudal block; Erector spinae block
Intervention type(s): Procedure; Procedure
Intervention description(s): . Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound,. Short axis (transverse) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.125% bupivacaine will expand the epidural space.; ● The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound) will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 30 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.
Other intervention name(s): caudal epidural block; ESP block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: caudal; Erector spinae block; lumbar surgery