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Completed

NCT Number: NCT01740193

Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair

The purpose of this research study is to find the best way to decrease pain in children right after surgery whom have had their hernia fixed. Right now, there are two different ways surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better than the other. The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method.

The results of this study will help learn how to best control pain in children having surgery for hernia repair.

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Key information

Age range

12 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hosptial Medical Center - Liberty Campus

Cincinnati, Ohio, 45229, United States

About this study

Unilateral inguinal herniorrhaphy is a commonly performed surgical procedure in the pediatric population. Multimodal anesthesia consisting of systemic narcotics, surgical wound infiltration with local anesthetic and ilioinguinal and/or iliohypogastric nerve blockade has traditionally been employed to achieve acceptable analgesia. Recently, ultrasound-based studies have demonstrated that blind abdominal wall injections are done with poor accuracy. Ultrasound-guided alternatives, such as the transverses abdominis plane (TAP) block, may improve analgesic efficacy and patient comfort in the post-operative period when compared to blind landmark based nerve blockade. There has been increasing utilization of the TAP block in the adult population due to the described ability to provide effective blockade of the thoracolumbar spinal nerves innervating the abdominal wall. We propose a randomized prospective evaluation of the analgesic efficacy comparing surgeon performed ilioinguinal/iliohypogastric block with ultrasound-guided TAP blockade in healthy ASA I and II pediatric patients undergoing unilateral herniorrhaphy on an outpatient basis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is male or female;
  • The subject is of any racial and ethnic groups;
  • The subject is age 12 months to 10 years (inclusive);
  • The subject weighs more than 8.0 kg (inclusive of the eighth kilogram);
  • The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures;
  • The subject is American Society of Anesthesiologists (ASA) patient classification I-II
  • The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

Exclusion criteria

  • Additional surgical procedures are being performed concurrently;
  • The subject is ASA classification > II;
  • The subject has pre-existing allergies to local anesthetics;
  • The subject receives midazolam as a premedication;
  • The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;
  • The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.

Treatment and study plan

TAP Block

Procedure

While the terminal branches of T7 to L1 cannot be visualized under ultrasound as they pass between the internal oblique and the transverse abdominis muscles, they are expected to lie within this plane. The three muscular layers of the abdominal wall, however, can be easily identified under ultrasound guidance. A needle is advanced under ultrasound guidance towards the fascial plane that separates the internal oblique and the transversus abdominis muscles, at which point local anesthetic is deposited under direct visualization.

Other names: transversus abdominis plane block

Ilioinguinal/iliohypogastric blockade

Procedure

Ilioinguinal and iliohypogastric blockade is performed as an injection after palpation of the anterior superior iliac spine followed be a perceived loss of resistance with insertion of the needle, or may be infiltrated locally following herniorrhaphy exposure as anatomic landmarks can prove to be difficult to locate in the anesthetized pediatric patient.

Primary outcomes

  1. Efficacy Outcome

    Time frame: Participants will be followed for the duration of post-anesthesia care unit stay, an expected average of 2 hours

    Worst FLACC score observed in the post-anesthesia care unit by the research coordinator during the first post-operative hour

Secondary outcomes

  1. Efficacy Outcome - Length of Recovery Room

    Time frame: participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

    time required for the patient to meet discharge criteria

  2. Confounding Variable - Electrocautery

    Time frame: participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

    whether or not cautery was used as a measure of surgical technique

  3. Confounding Variable - Surgical dissection

    Time frame: participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

    length of surgical procedure as an indicator of the extent of surgical dissection performed

  4. Confounding Variable - Length of time for TAP

    Time frame: participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

    length of time required to perform TAP block

  5. Efficacy Outcome - Post-operative Calls

    Time frame: participants will be followed for 48 hours after procedure

    Phone calls made to surgeons regarding parental concern of post-operative pain forty-eight hours post-operatively

  6. Outcome Measure - Number of patients with post-operative complications

    Time frame: participants will be followed for 48 hours after procedure

    presence of post-operative complications

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Randomized Prospective Comparison of Analgesic Efficacy of Surgeon Performed IIlioinguinal/Iliohypogastric Blockade With Ultrasound-Guided TAP Blockade in Pediatric Patients Undergoing Unilateral Herniorrhaphy on an Outpatient Basis

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 4, 2012
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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