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

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ClinicalTrials.gov Identifier: NCT03041935
Recruitment Status : Unknown
Verified January 2018 by Bryce Weber, Alberta Children's Hospital.
Recruitment status was:  Recruiting
First Posted : February 3, 2017
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Bryce Weber, Alberta Children's Hospital

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date January 10, 2018
Actual Study Start Date  ICMJE September 1, 2015
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • Post-operative pain [ Time Frame: Immediately following the procedure ]
    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).
  • Post-operative pain [ Time Frame: 15 minutes post-operatively ]
    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).
  • Post-operative pain [ Time Frame: 30 minutes post-operatively ]
    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).
  • Post-operative pain [ Time Frame: 60 minutes post-operatively ]
    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).
  • Post-operative pain [ Time Frame: 120 minutes post-operatively ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • Post-operative pain [ Time Frame: 24 hours post-operatively ]
    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.
  • Total ibuprofen consumption [ Time Frame: Up to 24 hours post-operatively ]
    Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
  • Total acetaminophen consumption [ Time Frame: Up to 24 hours post-operatively ]
    Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Orchiopexy Repair
Official Title  ICMJE Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Orchiopexy Repair
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Testicle Undescended
  • Pain, Postoperative
Intervention  ICMJE
  • Procedure: Ilioinguinal/iliohypogastric nerve block
    See arm description
  • Procedure: Caudal-epidural nerve block
    See arm description
  • Drug: Acetaminophen
    See arm description
  • Drug: Sevoflurane
    See arm description
  • Drug: Remifentanil
    See arm description
  • Drug: Propofol
    See arm description
  • Drug: Morphine
    See arm description
  • Drug: Ondansetron
    See arm description
  • Drug: Dexamethasone
    See arm description
  • Drug: Ketorolac
    See arm description
  • Drug: Ropivacaine
    See arm description
Study Arms  ICMJE
  • Active Comparator: Caudal-epidural nerve block
    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). An additional 0.2 mL/kg of ropivacaine 0.2% (max 4mL) will be used for scrotal skin infiltration.
    Interventions:
    • Procedure: Caudal-epidural nerve block
    • Drug: Acetaminophen
    • Drug: Sevoflurane
    • Drug: Remifentanil
    • Drug: Propofol
    • Drug: Morphine
    • Drug: Ondansetron
    • Drug: Dexamethasone
    • Drug: Ketorolac
    • Drug: Ropivacaine
  • Experimental: Ilioinguinal/iliohypogastric nerve block
    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). An additional 0.2 mL/kg of ropivacaine 0.2% (max 4mL) will be used for scrotal skin infiltration.
    Interventions:
    • Procedure: Ilioinguinal/iliohypogastric nerve block
    • Drug: Acetaminophen
    • Drug: Sevoflurane
    • Drug: Remifentanil
    • Drug: Propofol
    • Drug: Morphine
    • Drug: Ondansetron
    • Drug: Dexamethasone
    • Drug: Ketorolac
    • Drug: Ropivacaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 1, 2017)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2019
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy children (ASA I and II) between the ages of 6 months and 4 years presenting for elective orchiopexy 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 6 Months to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041935
Other Study ID Numbers  ICMJE REB14-1751
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bryce Weber, Alberta Children's Hospital
Study Sponsor  ICMJE Alberta Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alberta Children's Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP