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

Primary Purpose

Hydrocele, Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP block
Local Infiltration
Sponsored by
Kaveh Aslani, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocele

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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*

Sites / Locations

  • Beaumont Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP Group

Local Infiltration Group

Arm Description

Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.

Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 14, 2012
Last Updated
July 24, 2017
Sponsor
Kaveh Aslani, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01698268
Brief Title
Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery
Acronym
TAP
Official Title
The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kaveh Aslani, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study measures the difference in pain after hernia &/or hydrocele repair based on site of local anesthesia injection.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocele, Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Group
Arm Type
Experimental
Arm Description
Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
Arm Title
Local Infiltration Group
Arm Type
Active Comparator
Arm Description
Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.
Intervention Type
Procedure
Intervention Name(s)
Local Infiltration
Intervention Description
Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
Primary Outcome Measure Information:
Title
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)
Description
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.
Time Frame
Admission into PACU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaveh Aslani, MD
Organizational Affiliation
Beaumont Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Health System
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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