Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Orchiopexy Repair
Condition: Testicle Undescended; Pain, Postoperative
MeSH terms: Cryptorchidism; Pain, Postoperative
Study type: Interventional

Summary: 
      Surgical intervention to treat undescended testis is a very common pediatric surgical
      procedure, often performed using an inguinal incision or subscrotal incision approach.
      Children who undergo orchiopexy can suffer from a significant degree of discomfort
      postoperatively. The investigators are evaluating the effectiveness of an ultrasound guided
      caudal-epidural (CE) block to an US guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block
      in achieving post operative analgesia following a orchiopexy repair. It is hypothesized that
      US guided IIG/IHG nerve block leads to more effective pain control post-operatively while in
      hospital relative to an US guided CE block for orchiopexy surgery.
    

Detailed description: 
      Surgical intervention to treat undescended testis is a very common pediatric surgical
      procedure, often performed using an inguinal incision or subscrotal incision approach.
      Children who undergo orchiopexy can suffer from a significant degree of discomfort
      postoperatively. A multimodal pain management approach including medications such as
      acetaminophen, non-steroidal anti-inflammatory drugs and opioids have traditionally been used
      in combination with a regional anesthetic technique. Regional anesthetic techniques include
      surgical infiltration of local anesthetic, caudal-epidural (CE) block or an
      ilioinguinal/iliohypogastric (IIG/IHG) nerve block.

      Regional anesthetic techniques such as CE and ultrasound (US) guided IIG/IHG are
      well-established methods shown to reduce the use of intraoperative anesthetics and the need
      post operative rescue analgesia. Traditionally, IIG/IHG nerve blocks were completed using a
      landmark-based approach but due to unpredictable block results with failure rates over 30%
      and potentially serious complications such as unintentional intraperitoneal injection, many
      anesthesiologists preferred the more reliable CE technique (2, 3). However, while the CE
      provides excellent intraoperative anesthesia it provides short duration of post-operative
      analgesia (4-6 hours) and can be associated with lower limb motor block and urinary retention
      (4). Recent literature has demonstrated that an US guided IIG/IHG can be completed with
      smaller volume of local anesthetic with a success rate of up to 100% with low risk of
      complications. Furthermore there is evidence to suggest that it provides an increased
      duration of postoperative analgesia for pediatric patients undergoing groin surgery (3, 5).
      Finally, two publications retrospectively reviewing complications in over 45000 regional
      anesthetic blocks suggest that US guided peripheral nerve blocks (e.g., IIG/IHG) should be
      favoured over neuraxial techniques such as epidural and caudal anesthetics due to the
      risk-benefit profile (6,7). A recent meta-analysis comparing IIG/IIH block to the CE block in
      children notes that additional comparative studies are required as previous studies comparing
      these two techniques have many methodological limitations including small sample sizes, using
      blind (non-US guided) regional anesthetic techniques and grouping patients undergoing various
      surgical procedures (e.g., orchiopexy and hernia repair) despite significant differences in
      recovery pain profiles (8).

      The investigators are proposing to complete a prospective randomized single-blinded
      non-inferiority study to evaluate and compare the effectiveness of an US guided CE block to
      an US guided IIG/IHG nerve block in achieving post operative analgesia following orchiopexy
      for undescended testicle(s). Currently, a number of Pediatric Anesthesiologists at the
      Alberta Children's Hospital do not routinely complete IIG/IIH or CE blocks under ultrasound
      guidance. As part of this study investigators hope to provide necessary knowledge
      (sonoanatomy, technique) and offer supervised clinical training to anesthesiologists who are
      interested in participating in the study. While orchiopexy remains a common procedure, no
      studies have compared the use of US guided CE to US guided IIG/IHG. The aim of this study is
      to establish non-inferiority in post-operative pain while in hospital as assessed through the
      Face, Leg, Activity, Cry, Consolability (FLACC) scale for the US guided IIG/IHG as compared
      to US guided CE following orchiopexy surgery. Secondary objectives will assess for group
      differences in need for rescue analgesia in hospital, analgesia administered at home, and
      postoperative pain measures within 24 hours post hospital discharge.

      The investigators hypothesize that a US guided IIG/IHG nerve block leads to non-inferior
      objectively measured FLACC pain scores (≤ 1 point on FLACC scale) post-operatively while in
      hospital relative to an US guided CE block for orchiopexy surgery.
    

Intervention name(s): Ilioinguinal/iliohypogastric nerve block; Caudal-epidural nerve block; Acetaminophen; Sevoflurane; Remifentanil; Propofol; Morphine; Ondansetron; Dexamethasone; Ketorolac; Ropivacaine
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): See arm description; See arm description; See arm description; See arm description; See arm description; See arm description; See arm description; See arm description; See arm description; See arm description; See arm description
Intervention MeSH terms: Acetaminophen; Dexamethasone; Ketorolac; Morphine; Remifentanil; Ondansetron; Propofol; Ropivacaine; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Testicle; Pain; Orchiopexy; Caudal nerve block; Ilioinguinal nerve block