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ilioinguinal/iliohypogastric nerve block for Inguinal Hernia

N/A

Waitlist Available

Research Sponsored by Alberta Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post-operatively

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 60 Other Conditions

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.

Eligible Conditions

Inguinal Hernia
Infections
Postoperative Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Pain

Total acetaminophen consumption

Total ibuprofen consumption

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ilioinguinal/iliohypogastric nerve blockExperimental Treatment9 Interventions

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).

Group II: Caudal-epidural nerve blockActive Control9 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ilioinguinal/iliohypogastric nerve block

2015

N/A

~90

Propofol

FDA approved

Morphine

FDA approved