Sacral Erector Spinae,Penile and Caudal Block for Pain Relief After Hypospadias Surgery
Condition: Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius Surgery
Study type: Interventional

Summary: 
      Caudal anaesthesia is recommended for most surgical procedures of the lower part of the body,
      mainly below the umbilicus, including inguinal hernia repair, urinary and digestive tract
      surgery and orthopaedic procedures on the pelvic girdle and lower extremities.

      It has been well established that a dorsal penile nerve block immediately after surgery
      decreases postoperative pain in children undergoing hypospadias repair. For decades, penile
      block was widely and effectively used for various types of penile reconstructive surgery.

      Recently, due to improved composition, dosage and concentration of local anaesthetics and low
      incidence of negative side effects, such as motor blockade and postoperative nausea and
      vomiting, caudal anaesthesia has become one of the most used and accepted regional blocks for
      children undergoing hypospadias repair.

      However, postoperative patient comfort is a major issue after distal hypospadias repair and
      depends on adequate analgesia and unimpaired micturition, especially when no suprapubic
      catheter is in place. Micturition impairment and urinary retention is a known side effect of
      caudal block anaesthesia.

      The comparison of penile block and caudal block has not been described in the literature to
      our knowledge.

      Use of ESPB for different indications from different levels has become the new trend of
      regional anesthesia practice from the moment it was first defined . There have been many
      reports for its use in thoracic and lumbar levels.

      This great interest probably depends on its effectiveness as well as the ease of the block
      technique: injecting the local anesthetic deep to the erector spinae muscle (ESM) above the
      transverse process. With this report, we would like to identify a modification to sacral ESPB
      with our longitudinal midline approach with the presentation of a case of an infant who was
      scheduled for hypospadias repair.
    

Detailed description: 
      Patients will be randomly divided into three groups by using a computer-generated
      randomization. Sealed opaque envelopes containing group allocation will be before the blocks
      will be performed. Then, each patient will be asked to choose one of the envelopes and give
      to an anesthesiologist who will compare it to the computer-generated list and hence assignee
      her to one of the three groups. Anesthesiologist (who will be blinded to the collected data
      until the end of the study) will perform the block techniques and administer the medication.

        -  Group C (Caudal group) n=44: after prep and drep, in left lateral position caudal block
           will be performed with bupivacaine 0.25%, 1 ml/kg (max 20 ml).

        -  Group P (Penile block) n=44: after prep and drep in supine position, the penis will be
           retracted downward and fixed with leucoplast. The markers for injection will be,
           symphysis pubis, 0.5 to 1 cm lateral to the midline, the needle will be inserted
           vertically (medially-caudally) until penetrating fascia scarpa and bupivacaine 0.5%, 0.1
           ml/kg (max 2.5 ml), will be injected in each side. Blocks will be performed with 22-G
           needles and skin incision will be performed 20 minutes after block in each group.

        -  Group E (Erector spinea plain block group) n=44:

      Before the start of surgery, patient will be turned to prone position for block application.
      Following cleansing of the block area, linear ultrasound probe (Esaote My Lab 6 US machine,
      Florence, Italy) will be placed longitudinally to midline just above the sacrum . Median
      sacral crests and erector spinae muscle will be identified.

      A 22G, 50mm needle (B. Braun Melsungen, Germany) will be inserted from the edge of the probe
      using in-plane technique. Needle will be advanced with a cranial to caudal direction until
      its tip touched to the top of the 4th median sacral crest. Following negative aspiration, 8
      mL of 0, 25% Bupivacaine (with a dose of 1 mL/kg) will be injected for the block application.
      Then the patient will be turned to supine position and surgery started.

      Anesthesia Protocol 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 0.05 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 1 ug/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.

      At the end of the surgery, the sevoflurane will be switched off with reversal of the muscle
      relaxation by combination of neostigmine 0.04 mg/kg and atropine 0.01 mg/kg. Awake extubation
      will be then performed with transporting the child to the recovery room for adequate
      postoperative monitoring. All the children will receive paracetamol 15 mg/kg i.v infusion
      every 6 h. The children will be discharged from the recovery room when their modified
      Aldrete's score reach 10.

      Postoperatively, patient was evaluated with Face, Leg, Activity, Cry, Consolability Revised
      (FLACC-R) score for pain management and it was 0 or 1 for entire postoperative 24 h. In
      recovery or ward, rectal acetaminophen was administered for an age-appropriate pain score
      between 3 and 5 (0-10) and intravenous meperidine 1 mg/kg for an age-appropriate pain score
      of >5 (0-10).

      Measurements The following parameters will be recorded by an anesthesia resident not included
      in the study and blinded to its groups: -

        -  Demographic data (Age in month, body weight, and ASA class)

        -  Total consumption of pethidine (mg/kg) in first day postoperatively. (secondary outcome)

        -  The duration of postoperative analgesia which defied as: The time (in hours)from the
           beginning of the block to the first rescue analgesia request (primary outcome)

        -  The postoperative pain score (FLAC pain score) every 2 hours in the first 8 hours then
           every 4 hours till 24 h. (Secondary outcome)

        -  The total dose of fentanyl consumed intraoperatively.

        -  The incidence of perioperative complications including bradycardia, hypotension, nausea
           and vomiting, localized hematoma, infection, or pruritis.
    

Intervention name(s): Penile block; Erector spinea plain block; Caudal block
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Penile block was performed in supine position. The penis was retracted caudally and then fixed with a leucoplast. After identifying the symphysis pubis (SP), a 22-gauge needle was inserted vertically about 1 cm lateral to the SP, and bupivacaine 0.5% (0.1 ml/kg, maximum 2.5 ml) was injected on each side after penetrating the Scarpa's fascia.; Ultrasound guided ESPB was performed in prone position by Philips © (CX50 Extreme edition). The superficial probe was placed longitudinally at the midline just above the sacrum, and both erector spinae muscles and median sacral crests were identified. Using the in-plane approach, a 22-gauge needle was inserted in a craniocaudal direction till reaching the tip of the fourth median sacral crest. After negative aspiration to avoid intravascular or intrathecal puncture, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered.; Caudal block was performed in the left lateral position. A 22 G needle was inserted through the sacral hiatus. The loss of resistance method was used to pass through the sacrococcygeal membrane and enter the caudal epidural space. Negative aspiration was then performed. When no blood or cerebrospinal fluid was observed, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. The patient was returned to the supine position after the procedure was completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment