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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

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

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

NCT ID

NCT01740193

First Posted

November 30, 2012

Last Updated

December 18, 2018

Sponsor

Children's Hospital Medical Center, Cincinnati

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

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

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

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

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