Cincinnati Children's Hosptial Medical Center - Liberty Campus
Cincinnati, Ohio, 45229, United States
NCT Number: NCT01740193
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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Notify Me12 month–10 year
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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
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
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
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
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
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
Time frame: participants will be followed for 48 hours after procedure
presence of post-operative complications
Children's Hospital Medical Center, Cincinnati
Other
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
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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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