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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by William Beaumont Hospitals
Sponsor:
Information provided by (Responsible Party):
Kaveh Aslani, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01698268
First received: August 14, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

This single-center, prospective, single blind, randomized study will enroll 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.


Condition Intervention Phase
Hydrocele
Inguinal Hernia
Procedure: TAP block
Procedure: Field Block
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs). [ Time Frame: Admission into PACU until hospital discharge, between 1 - 2 hours. ] [ Designated as safety issue: No ]
  • Phone call to parents for pain medication at 24 hours post hospital discharge. [ Time Frame: At 24 hours after hospital discharge. ] [ Designated as safety issue: No ]
  • Total pain medication from time of PACU admission until 24 hours post-operatively as documented by all pain given. [ Time Frame: From PACU admission until 24 hours after hospital discharge. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parental satisfaction with pain control, as measured by a 10 point Likert scale. [ Time Frame: Telephone call to parents at 24 hours post hospital discharge. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP Group (TG)
25 subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP Blocks will be performed under ultrasound guidance via Sonosite device with an in-plane technique.
Procedure: TAP block
Active Comparator: Field Group (FG)
25 subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine by the surgeon.
Procedure: Field Block

  Eligibility

Ages Eligible for Study:   2 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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*
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698268

Contacts
Contact: Cynthia Turzewski, RN, BSN (248)898-1907 Cynthia.Turzewski@beaumont.edu

Locations
United States, Michigan
Beaumont Health System Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Cynthia Turzewski,RN, BSN    248-898-1907    Cynthia.Turzewksi@beaumont.edu   
Principal Investigator: Kaveh Aslani, MD         
Sponsors and Collaborators
Kaveh Aslani, MD
Investigators
Principal Investigator: Kaveh Aslani, MD Beaumont Health System
  More Information

No publications provided

Responsible Party: Kaveh Aslani, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01698268     History of Changes
Other Study ID Numbers: 2011-213
Study First Received: August 14, 2012
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on September 30, 2014