Study of Transverse Abdominis Plane (TA… | Clinical Trial

Key information

Conditions

Hydrocele Endocrine System Diseases Genital Diseases Genital Diseases, Male Gonadal Disorders Hernia Hernia, Abdominal Hernia, Inguinal Inguinal Hernia Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Testicular Diseases Testicular Hydrocele Urogenital Diseases

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Health System

Royal Oak, Michigan, 48073, United States

About this study

This single-center, prospective, single blind, randomized study will enroll up to 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Children 2-8 years of age
Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak
American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma)

Exclusion criteria

History of allergy to study medications
Enrollment in concurrent research study
Pregnant patients*
Students/trainees/staff*
Mentally disabled/cognitively impaired*

Treatment and study plan

TAP Block

Procedure

TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.

local infiltration

Procedure

Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.

Primary outcomes

FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)

Time frame: Admission into PACU

FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.

Sponsors and collaborators

Lead sponsor

Kaveh Aslani, MD

Other

Registry information

Official study title

The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair

Acronym: TAP

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Oct 2, 2012
Registry last updated: Aug 24, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed