Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Surgical intervention to treat a inguinal hernia is a very common pediatric surgical procedure, often performed using an inguinal incision. Children who undergo hernia repair 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 hernia 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 inguinal hernia surgery.

Detailed Description
-----------------
Surgical intervention to treat a inguinal hernia is a very common pediatric surgical procedure, often performed using an inguinal incision. Children who undergo hernia repair 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. 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. 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. 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. 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. 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 a hernia repair. 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 a hernia repair 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 hernia repair 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. 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 inguinal hernia surgery.

Official Title
-----------------
Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair

Conditions
-----------------
Hernia, Inguinal, Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Ilioinguinal/iliohypogastric nerve block
* Procedure: Caudal-epidural nerve block
* Drug: Acetaminophen
* Drug: Sevoflurane
* Drug: Remifentanil
* Drug: Propofol
* Drug: Morphine
* Drug: Ondansetron
* Drug: Dexamethasone
* Drug: Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children (ASA I and II) between the ages of 6 months and 4 years presenting for elective hernia repair who are scheduled for day stay only. Exclusion Criteria: Patients with a history of clinically important renal, hepatic, cardiac, or neurological conditions and those with a history of allergic reactions to local anesthetics, bleeding diatheses, coagulopathy, and spinal abnormality such as a sacral dimple will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal-epidural nerve block<br>All patients will receive acetaminophen (15mg/kg) within one hour of induction of anesthesia. Inhalation induction of anesthesia will be performed with sevoflurane in 100% O2. A single dose of up to 2-4 mg/kg of propofol and Remifentanil 0.5-1mcg/kg will be given prior insertion of a laryngeal mask airway or endotracheal tube. Anesthesia will be maintained with Propofol and Remifentanil (2.5mcg/ml) which will be started at 300 mcg/kg/min and titrated to effect. If necessary additional boluses of Propofol (1mg/kg) and/or Remifentanil (0.5-1mcg/kg) and/or Morphine 0.05mg/kg boluses IV will be administered. Ondansetron (0.1mg/kg) and Dexamethasone (0.15mg/kg) will be given as antiemetic prophylaxis for all patients. Ketorolac 0.3mg/kg will be given to each patient. The CE group will receive an US-confirmed CE nerve block with 0.8 mL/kg of 0.2% ropivacaine (maximum 15 mL). | Procedure: Caudal-epidural nerve block<br>* See arm description<br>Drug: Acetaminophen<br>* See arm description<br>Drug: Sevoflurane<br>* See arm description<br>Drug: Remifentanil<br>* See arm description<br>Drug: Propofol<br>* See arm description<br>Drug: Morphine<br>* See arm description<br>Drug: Ondansetron<br>* See arm description<br>Drug: Dexamethasone<br>* See arm description<br>Drug: Ketorolac<br>* See arm description<br>|
| Experimental: ilioinguinal/iliohypogastric nerve block<br>All patients will receive acetaminophen (15mg/kg) within one hour of induction of anesthesia. Inhalation induction of anesthesia will be performed with sevoflurane in 100% O2. A single dose of up to 2-4 mg/kg of propofol and Remifentanil 0.5-1mcg/kg will be given prior insertion of a laryngeal mask airway or endotracheal tube. Anesthesia will be maintained with Propofol and Remifentanil (2.5mcg/ml) which will be started at 300 mcg/kg/min and titrated to effect. If necessary additional boluses of Propofol (1mg/kg) and/or Remifentanil (0.5-1mcg/kg) and/or Morphine 0.05mg/kg boluses IV will be administered. Ondansetron (0.1mg/kg) and Dexamethasone (0.15mg/kg) will be given as antiemetic prophylaxis for all patients. Ketorolac 0.3mg/kg will be given to each patient. The IIG/IHG group will receive a unilateral US guided IIG/IHG with 0.4mL/kg of ropivacaine 0.2% (max 12 mL). | Procedure: Ilioinguinal/iliohypogastric nerve block<br>* See arm description<br>Drug: Acetaminophen<br>* See arm description<br>Drug: Sevoflurane<br>* See arm description<br>Drug: Remifentanil<br>* See arm description<br>Drug: Propofol<br>* See arm description<br>Drug: Morphine<br>* See arm description<br>Drug: Ondansetron<br>* See arm description<br>Drug: Dexamethasone<br>* See arm description<br>Drug: Ketorolac<br>* See arm description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age). | Immediately following the procedure | 
| Post-operative pain | Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age). | 15 minutes post-operatively | 
| Post-operative pain | Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age). | 30 minutes post-operatively | 
| Post-operative pain | Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age). | 60 minutes post-operatively | 
| Post-operative pain | Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age). | 120 minutes post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Patients will be contacted 24 hours following their surgery to complete the parents' postoperative pain measure (PPPM). The PPPM is a well-established post-operative pain assessment tool with high inter-rater reliability and construct validity that has been designed specifically for use by parents in the post-operative care of their children. The measure includes 15 items scored between 0 and 1. The questionnaire will be completed over the telephone within 24 hours of the patient's surgery. | 24 hours post-operatively | 
| Total ibuprofen consumption | Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up | Up to 24 hours post-operatively | 
| Total acetaminophen consumption | Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up | Up to 24 hours post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, Caudal nerve block, Ilioinguinal nerve block, Pain