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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740193
• Other study ID #: 2011-1778
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2017

Study information

• Verified date: December 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain

Intervention

Procedure:
• TAP Block
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.
• Ilioinguinal/iliohypogastric blockade
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hosptial Medical Center - Liberty Campus	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View Citation

Fredrickson MJ, Seal P. Ultrasound-guided transversus abdominis plane block for neonatal abdominal surgery. Anaesth Intensive Care. 2009 May;37(3):469-72. — View 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. — View 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy Outcome - Length of Recovery Room	time required for the patient to meet discharge criteria	participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours
Secondary	Confounding Variable - Electrocautery	whether or not cautery was used as a measure of surgical technique	participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours
Secondary	Confounding Variable - Surgical dissection	length of surgical procedure as an indicator of the extent of surgical dissection performed	participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours
Secondary	Confounding Variable - Length of time for TAP	length of time required to perform TAP block	participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours
Secondary	Efficacy Outcome - Post-operative Calls	Phone calls made to surgeons regarding parental concern of post-operative pain forty-eight hours post-operatively	participants will be followed for 48 hours after procedure
Secondary	Outcome Measure - Number of patients with post-operative complications	presence of post-operative complications	participants will be followed for 48 hours after procedure