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

NCT01740193 | Completed

• 1 other identifier: 2011-1778
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Inguinal Hernia

Keywords

Pain; Regional Anesthesia; ultrasound; transversus abdominis plane; herniorrhaphy; pediatrics

Outcome Measures

Primary Outcomes (1)

• Efficacy Outcome

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

  Participants will be followed for the duration of post-anesthesia care unit stay, an expected average of 2 hours

Secondary Outcomes (6)

• Efficacy Outcome - Length of Recovery Room

  participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

• Confounding Variable - Electrocautery

  participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

• Confounding Variable - Surgical dissection

  participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

• Confounding Variable - Length of time for TAP

  participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

• Efficacy Outcome - Post-operative Calls

  participants will be followed for 48 hours after procedure

Study Arms (2)

TAP Block

ACTIVE COMPARATOR

Procedure: TAP Block

Ilioinguinal/iliohypogastric blockade

ACTIVE COMPARATOR

Procedure: Ilioinguinal/iliohypogastric blockade

Interventions

TAP Block PROCEDURE

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.

Also known as: transversus abdominis plane block

TAP Block

Ilioinguinal/iliohypogastric blockade PROCEDURE

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.

Ilioinguinal/iliohypogastric blockade

Eligibility Criteria

• Age: 12 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hosptial Medical Center - Liberty Campus

Cincinnati, Ohio, 45229, United States

Location

Related Publications (6)

• 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.

  PMID: 19561014 BACKGROUND

• 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.

  PMID: 18768050 BACKGROUND

• 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.

  PMID: 21177284 BACKGROUND

• 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.

  PMID: 19499870 BACKGROUND

• 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.

  PMID: 9459225 BACKGROUND

• Hadzic A, New York School of Regional Anesthesia.: Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill, Medical Pub. Division; 2007.

  BACKGROUND

MeSH Terms

Conditions

Pain; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Study Officials

• Jamie Furstein, CRNA, DNAP

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

US (1)