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Hernia, InguinalNCT03041948

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

A study testing Ilioinguinal/iliohypogastric nerve block, Caudal-epidural nerve block and Acetaminophen in people with Hernia, Inguinal and Pain, Postoperative, run by Alberta Children's Hospital at 2 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 4 yearsHealthy volunteers can take part
Conditions the study is for
Hernia, Inguinal, Pain, Postoperative
What is being tested?
Ilioinguinal/iliohypogastric nerve block, Caudal-epidural nerve block and Acetaminophen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesCanada
Study dates
1 Sep 2015to 1 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 4 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites, 2 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Bryce Weber, MD FRCSC, 587-227-6652, bryce.weber@albertahealthservices.ca

    Bryce Weber, MD

    Recruiting

  • Royal University Hospital/University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 0W8

    Jennifer O'Brien, PhD, (306) 655-6497, Jennifer.O'Brien@saskatoonhealthregion.ca

    Recruiting

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Ilioinguinal/iliohypogastric nerve block, Caudal-epidural nerve block, Acetaminophen, Sevoflurane, Remifentanil
Keywords
Inguinal hernia, Caudal nerve block, Ilioinguinal nerve block, Pain
Medical subject headings
Hernia, Inguinal, Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03041948
Study groupRoleWhat they receive
Caudal-epidural nerve blockActive comparatorAll 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).
Receives: Procedure: Caudal-epidural nerve block; Drug: Acetaminophen; Drug: Sevoflurane; Drug: Remifentanil; Drug: Propofol; Drug: Morphine; Drug: Ondansetron; Drug: Dexamethasone; Drug: Ketorolac
ilioinguinal/iliohypogastric nerve blockExperimentalAll 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).
Receives: Procedure: Ilioinguinal/iliohypogastric nerve block; Drug: Acetaminophen; Drug: Sevoflurane; Drug: Remifentanil; Drug: Propofol; Drug: Morphine; Drug: Ondansetron; Drug: Dexamethasone; Drug: Ketorolac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Immediately following the procedure

  2. 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).

    Measured: 15 minutes post-operatively

  3. 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).

    Measured: 30 minutes post-operatively

  4. 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).

    Measured: 60 minutes post-operatively

  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).

    Measured: 120 minutes post-operatively

Secondary outcomes (3)

  1. 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.

    Measured: 24 hours post-operatively

  2. Total ibuprofen consumption

    Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up

    Measured: Up to 24 hours post-operatively

  3. Total acetaminophen consumption

    Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up

    Measured: Up to 24 hours post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study start1 Sep 2015
  3. Primary completion1 Sep 2018 (estimated)
  4. Study completion1 Sep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03041948
Sponsor's protocol ID
REB15-0434
Status last verified
Nov 2017
First submitted
1 Feb 2017
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

    PubMed 21197314

  • 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.

    PubMed 22338610

  • 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.

    PubMed 18165559

  • 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.

    PubMed 19627532

  • 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.

    PubMed 23493806

  • 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.

    PubMed 21199114

  • 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.

    PubMed 22696610

  • 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.

    PubMed 25162033

  • 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.

    PubMed 16996689

  • 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.

    PubMed 9220806

  • 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.

    PubMed 14527704

  • 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.

    PubMed 19840089

Questions about this trial

What is this clinical trial studying?

A study testing Ilioinguinal/iliohypogastric nerve block, Caudal-epidural nerve block and Acetaminophen in people with Hernia, Inguinal and Pain, Postoperative, run by Alberta Children's Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative pain (time frame: Immediately following the procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041948, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

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