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

Not Applicable

Completed

• Conditions: Pain; Inguinal Hernia
• Interventions: Procedure: TAP Block; Procedure: Ilioinguinal/iliohypogastric blockade

• Registration Number: NCT01740193
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block	TAP Block	-
Ilioinguinal/iliohypogastric blockade	Ilioinguinal/iliohypogastric blockade	-

Primary Outcome Measures

Name	Time	Method
Efficacy Outcome	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 Outcome Measures

Name	Time	Method
Confounding Variable - Length of time for TAP	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
Efficacy Outcome - Post-operative Calls	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
Outcome Measure - Number of patients with post-operative complications	participants will be followed for 48 hours after procedure	presence of post-operative complications
Efficacy Outcome - Length of Recovery Room	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
Confounding Variable - Electrocautery	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
Confounding Variable - Surgical dissection	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

Trial Locations

Locations (1)

Cincinnati Children's Hosptial Medical Center - Liberty Campus; 🇺🇸 Cincinnati, Ohio, United States