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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

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.

Condition or disease Intervention/treatment Phase
Testicle Undescended Pain, Postoperative 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 Drug: Ropivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Orchiopexy Repair
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Arm Intervention/treatment
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.
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

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.
Procedure: Ilioinguinal/iliohypogastric 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




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041935


Locations
Layout table for location information
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Bryce Weber, MD FRCSC    587-227-6652    bryce.weber@albertahealthservices.ca   
Principal Investigator: Bryce Weber, MD         
Sponsors and Collaborators
Alberta Children's Hospital

Publications:

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Responsible Party: Bryce Weber, Pediatric Urologist, Alberta Children's Hospital
ClinicalTrials.gov Identifier: NCT03041935    
Other Study ID Numbers: REB14-1751
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bryce Weber, Alberta Children's Hospital:
Testicle
Pain
Orchiopexy
Caudal nerve block
Ilioinguinal nerve block
Additional relevant MeSH terms:
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Cryptorchidism
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Testicular Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Acetaminophen
Dexamethasone
Dexamethasone acetate
Ketorolac
Ketorolac Tromethamine
Morphine
Remifentanil
Ondansetron
Propofol
Ropivacaine
Sevoflurane
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs