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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaveh Aslani, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01698268
First received: August 14, 2012
Last updated: March 31, 2017
Last verified: March 2017
  Purpose
Study measures the difference in pain after hernia &/or hydrocele repair based on site of local anesthesia injection.

Condition Intervention
Hydrocele Inguinal Hernia Procedure: TAP block Procedure: Local Infiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
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 Kaveh Aslani, MD, William Beaumont Hospitals:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: February 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP Group
Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
Procedure: TAP block
TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.
Active Comparator: Local Infiltration Group
Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
Procedure: Local Infiltration
Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.

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.
  Eligibility

Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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

Locations
United States, Michigan
Beaumont Health System
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kaveh Aslani, MD
Investigators
Principal Investigator: Kaveh Aslani, MD Beaumont Health System
  More Information

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
Results First Received: January 18, 2017
Last Updated: March 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2017