Erector Spinea Plane Block in Pediatric Hip Surgery
Condition: Postoperative Pain; Opioid Use
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective randomized controlled double-blind study will be carried out to evaluate the
      effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in
      children after hip surgeries, the total morphine consumption in the first postoperative day
      will be the primary outcome and the time to first request for rescue analgesia and
      postoperative pain score will be the secondary outcome.

      The study will be carried out on pediatric patients undergoing hip surgery where they will
      receive real or sham ultrasound guided erector spinae plane block before the onset of the
      surgery.
    

Detailed description: 
      This prospective randomized controlled double-blind study will be carried out to evaluate the
      effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in
      children after hip surgeries.

      Primary outcome: Total morphine consumption in the first postoperative day. Secondary
      outcome: The time to first request for rescue analgesia and postoperative pain score.

      This clinical trial will be carried out in Tanta University Hospitals for a period of 6 month
      that may be extended on pediatric patients scheduled for surgical treatment of hip disorder
      under general anesthesia.

      A written informed consent will be obtained from the parents of all patients. Randomization
      will be performed by an independent data manager assigned the patients to groups based on a
      computer-generated randomization program introduced in closed opaque envelope.

      Group 1 (20 patients): patients in this group will receive sham ipsilateral ultrasound-guided
      single shot erector spinae block at the level of second lumbar vertebra after induction of
      anesthesia and before the start of surgery without injection of local anesthetics.

      Group 2 (20 patients): patients in this group will receive real ipsilateral ultrasound-guided
      single shot erector spinae block att the level of second lumbar vertebra after induction of
      anesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain
      bupivacaine.

      Anesthetic technique All the patients will be adequately assessed preoperatively in the
      anesthesia clinic through history taking, general and local examination, and requesting
      investigation. Adequate explanation of the procedure, benefit, and potential hazards will be
      done to the parents with final reassurance of them. All children will receive sedation in the
      form of oral midazolam 0.5 mg/kg 15 minutes before admission to the operating room.

      Upon admission to the operating room, intravascular access will be obtained with starting i.v
      infusion of Dextrose 5% in normal saline (7 ml/kg). Then, the patients will be attached to a
      monitor of pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide,
      temperature, and 5 leads electrocardiogram. Induction of anesthesia will be carried out using
      sevoflurane 6% in oxygen: air (4:1) till the child loss the consciousness, then, fentanyl 0.5
      ug/kg will be given intravenously and atracurium 0.5 mg/kg will be given intravenously to
      facilitate endotracheal intubation. A suitable sized endotracheal tube will be introduced and
      secured with connection of the patients to a mechanical ventilator (pressure-controlled mode)
      which parameters will be adjusted to maintain end-tidal carbon dioxide 36-40 mmHg.

      Anesthesia will be maintained by sevoflurane (1 MAC) with incremental doses of atracurium.
      Also, incremental doses of fentanyl 0.5 ug/kg will be given i.v in case of increase
      bispectral index (BIS) more than 60 or by increase in the heart rate or the mean arterial
      pressure by more than 20% of the baseline values.
    

Intervention name(s): Real ultrasound-guided single shot erector spinae plane block (ESP B); Sham ultrasound-guided single shot erector spinae plane block (ESP B)
Intervention type(s): Procedure; Radiation
Intervention description(s): ESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM.
After negative aspiration, 0.3 mL/kg- of bupivacaine 0.25% will be injected confirming correct position by visualizing the solution lifting the ESM off the transverse process .Spread of LA between the L1 and L4 transverse processes will be thereafter visually tracked with the transducer. In the control group, no local anesthetics will be injected.; EESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM.
No local anesthetics will be injected
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment Prospective study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Erecto spinae plane; Hip surgery; Children; Pain; Morphine consumption