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

NCT03041935 | Completed

• 1 other identifier: REB14-1751
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicle Undescended; Pain, Postoperative

Keywords

Testicle; Pain; Orchiopexy; Caudal nerve block; Ilioinguinal nerve block

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Post-operative pain

  24 hours post-operatively

• Total ibuprofen consumption

  Up to 24 hours post-operatively

• Total acetaminophen consumption

  Up to 24 hours post-operatively

Study Arms (2)

Caudal-epidural nerve block

ACTIVE COMPARATOR

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; Drug: Acetaminophen; Drug: Sevoflurane; Drug: Remifentanil; Drug: Propofol; Drug: Morphine; Drug: Ondansetron; Drug: Dexamethasone; Drug: Ketorolac; Drug: Ropivacaine

Ilioinguinal/iliohypogastric nerve block

EXPERIMENTAL

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; Drug: Acetaminophen; Drug: Sevoflurane; Drug: Remifentanil; Drug: Propofol; Drug: Morphine; Drug: Ondansetron; Drug: Dexamethasone; Drug: Ketorolac; Drug: Ropivacaine

Interventions

Ilioinguinal/iliohypogastric nerve block PROCEDURE

See arm description

Ilioinguinal/iliohypogastric nerve block

Caudal-epidural nerve block PROCEDURE

See arm description

Caudal-epidural nerve block

Acetaminophen DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Sevoflurane DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Remifentanil DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Propofol DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Morphine DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Ondansetron DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Dexamethasone DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Ketorolac DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Ropivacaine DRUG

See arm description

Caudal-epidural nerve block; Ilioinguinal/iliohypogastric nerve block

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alberta Children's Hospital: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (12)

• Verghese ST, Hannallah RS. Acute pain management in children. J Pain Res. 2010 Jul 15;3:105-23. doi: 10.2147/jpr.s4554.

  PMID: 21197314 BACKGROUND

• Koo BN, Hong JY, Song HT, Kim JM, Kil HK. Ultrasonography reveals a high prevalence of lower spinal dysraphism in children with urogenital anomalies. Acta Anaesthesiol Scand. 2012 May;56(5):624-8. doi: 10.1111/j.1399-6576.2011.02612.x. Epub 2012 Feb 16.

  PMID: 22338610 BACKGROUND

• Weintraud M, Marhofer P, Bosenberg A, Kapral S, Willschke H, Felfernig M, Kettner S. Ilioinguinal/iliohypogastric blocks in children: where do we administer the local anesthetic without direct visualization? Anesth Analg. 2008 Jan;106(1):89-93, table of contents. doi: 10.1213/01.ane.0000287679.48530.5f.

  PMID: 18165559 BACKGROUND

• Jagannathan N, Sohn L, Sawardekar A, Ambrosy A, Hagerty J, Chin A, Barsness K, Suresh S. Unilateral groin surgery in children: will the addition of an ultrasound-guided ilioinguinal nerve block enhance the duration of analgesia of a single-shot caudal block? Paediatr Anaesth. 2009 Sep;19(9):892-8. doi: 10.1111/j.1460-9592.2009.03092.x. Epub 2009 Jul 13.

  PMID: 19627532 BACKGROUND

• Abdellatif AA. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks versus caudal block for postoperative analgesia in children undergoing unilateral groin surgery. Saudi J Anaesth. 2012 Oct-Dec;6(4):367-72. doi: 10.4103/1658-354X.105868.

  PMID: 23493806 BACKGROUND

• Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.

  PMID: 21199114 BACKGROUND

• Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13.

  PMID: 22696610 BACKGROUND

• Shanthanna H, Singh B, Guyatt G. A systematic review and meta-analysis of caudal block as compared to noncaudal regional techniques for inguinal surgeries in children. Biomed Res Int. 2014;2014:890626. doi: 10.1155/2014/890626. Epub 2014 Aug 5.

  PMID: 25162033 BACKGROUND

• von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. doi: 10.1016/j.pain.2006.08.014. Epub 2006 Sep 25.

  PMID: 16996689 BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.

  PMID: 14527704 BACKGROUND

• Cole J, Shepherd M, Young P. Intranasal fentanyl in 1-3-year-olds: a prospective study of the effectiveness of intranasal fentanyl as acute analgesia. Emerg Med Australas. 2009 Oct;21(5):395-400. doi: 10.1111/j.1742-6723.2009.01216.x.

  PMID: 19840089 BACKGROUND

MeSH Terms

Conditions

Cryptorchidism; Pain, Postoperative; Pain

Interventions

Acetaminophen; Sevoflurane; Remifentanil; Propofol; Morphine; Ondansetron; Dexamethasone; Ketorolac; Ropivacaine

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Indomethacin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Urologist

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: September 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

CA (1)