search
Back to results

Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair

Primary Purpose

Pain, Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP Block
Ilioinguinal/iliohypogastric blockade
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Regional Anesthesia, ultrasound, transversus abdominis plane, herniorrhaphy, pediatrics

Eligibility Criteria

12 Months - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject is male or female;
  • The subject is of any racial and ethnic groups;
  • The subject is age 12 months to 10 years (inclusive);
  • The subject weighs more than 8.0 kg (inclusive of the eighth kilogram);
  • The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures;
  • The subject is American Society of Anesthesiologists (ASA) patient classification I-II
  • The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

Exclusion Criteria:

  • Additional surgical procedures are being performed concurrently;
  • The subject is ASA classification > II;
  • The subject has pre-existing allergies to local anesthetics;
  • The subject receives midazolam as a premedication;
  • The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;
  • The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.

Sites / Locations

  • Cincinnati Children's Hosptial Medical Center - Liberty Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAP Block

Ilioinguinal/iliohypogastric blockade

Arm Description

Outcomes

Primary Outcome Measures

Efficacy Outcome
Worst FLACC score observed in the post-anesthesia care unit by the research coordinator during the first post-operative hour

Secondary Outcome Measures

Efficacy Outcome - Length of Recovery Room
time required for the patient to meet discharge criteria
Confounding Variable - Electrocautery
whether or not cautery was used as a measure of surgical technique
Confounding Variable - Surgical dissection
length of surgical procedure as an indicator of the extent of surgical dissection performed
Confounding Variable - Length of time for TAP
length of time required to perform TAP block
Efficacy Outcome - Post-operative Calls
Phone calls made to surgeons regarding parental concern of post-operative pain forty-eight hours post-operatively
Outcome Measure - Number of patients with post-operative complications
presence of post-operative complications

Full Information

First Posted
November 30, 2012
Last Updated
December 18, 2018
Sponsor
Children's Hospital Medical Center, Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT01740193
Brief Title
Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inguinal Hernia
Keywords
Pain, Regional Anesthesia, ultrasound, transversus abdominis plane, herniorrhaphy, pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block
Arm Type
Active Comparator
Arm Title
Ilioinguinal/iliohypogastric blockade
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TAP Block
Other Intervention Name(s)
transversus abdominis plane block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ilioinguinal/iliohypogastric blockade
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy Outcome
Description
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 duration of post-anesthesia care unit stay, an expected average of 2 hours
Secondary Outcome Measure Information:
Title
Efficacy Outcome - Length of Recovery Room
Description
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
Title
Confounding Variable - Electrocautery
Description
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
Title
Confounding Variable - Surgical dissection
Description
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
Title
Confounding Variable - Length of time for TAP
Description
length of time required to perform TAP block
Time Frame
participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours
Title
Efficacy Outcome - Post-operative Calls
Description
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
Title
Outcome Measure - Number of patients with post-operative complications
Description
presence of post-operative complications
Time Frame
participants will be followed for 48 hours after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject is male or female; The subject is of any racial and ethnic groups; The subject is age 12 months to 10 years (inclusive); The subject weighs more than 8.0 kg (inclusive of the eighth kilogram); The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures; The subject is American Society of Anesthesiologists (ASA) patient classification I-II The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate. Exclusion Criteria: Additional surgical procedures are being performed concurrently; The subject is ASA classification > II; The subject has pre-existing allergies to local anesthetics; The subject receives midazolam as a premedication; The subject has an imminent life threatening condition that impacts the ability to obtain informed consent; The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Furstein, CRNA, DNAP
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hosptial Medical Center - Liberty Campus
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19561014
Citation
Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
Results Reference
background
PubMed Identifier
18768050
Citation
Fredrickson M, Seal P, Houghton J. Early experience with the transversus abdominis plane block in children. Paediatr Anaesth. 2008 Sep;18(9):891-2. doi: 10.1111/j.1460-9592.2008.02591.x. No abstract available.
Results Reference
background
PubMed Identifier
21177284
Citation
Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. 2011 Mar;106(3):380-6. doi: 10.1093/bja/aeq363. Epub 2010 Dec 21.
Results Reference
background
PubMed Identifier
19499870
Citation
Fredrickson MJ, Seal P. Ultrasound-guided transversus abdominis plane block for neonatal abdominal surgery. Anaesth Intensive Care. 2009 May;37(3):469-72. doi: 10.1177/0310057X0903700303.
Results Reference
background
PubMed Identifier
9459225
Citation
Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
Results Reference
background
Citation
Hadzic A, New York School of Regional Anesthesia.: Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill, Medical Pub. Division; 2007.
Results Reference
background

Learn more about this trial

Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair

We'll reach out to this number within 24 hrs