Cincinnati, Ohio 45229

  • Inguinal Hernia

Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

2011-1778


NCT ID:

NCT01740193


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

12 Months


Maximum Age:

10 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Medical Center, Cincinnati


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

59


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jamie Furstein, CRNA, DNAP
Principal Investigator
Children's Hospital Medical Center, Cincinnati

Study Dates

Start Date:August 2012
Completion Date:December 2017
Completion Type:Actual
Primary Completion Date:June 2017
Primary Completion Type:Actual
Verification Date:December 2018
Last Changed Date:December 18, 2018
First Received Date:November 30, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Efficacy Outcome
Time Frame:Participants will be followed for the duration of post-anesthesia care unit stay, an expected averag
Safety Issues:False
Description:Worst FLACC score observed in the post-anesthesia care unit by the research coordinator during the first post-operative hour
Outcome Type:Secondary Outcome
Measure:Efficacy Outcome - Length of Recovery Room
Time Frame:participants will be followed for the length of the surgical procedure, an expected average of 1.5 h
Safety Issues:False
Description:time required for the patient to meet discharge criteria
Outcome Type:Secondary Outcome
Measure:Confounding Variable - Electrocautery
Time Frame:participants will be followed for the length of the surgical procedure, an expected average of 1.5 h
Safety Issues:False
Description:whether or not cautery was used as a measure of surgical technique
Outcome Type:Secondary Outcome
Measure:Confounding Variable - Surgical dissection
Time Frame:participants will be followed for the length of the surgical procedure, an expected average of 1.5 h
Safety Issues:False
Description:length of surgical procedure as an indicator of the extent of surgical dissection performed
Outcome Type:Secondary Outcome
Measure:Confounding Variable - Length of time for TAP
Time Frame:participants will be followed for the length of the surgical procedure, an expected average of 1.5 h
Safety Issues:False
Description:length of time required to perform TAP block
Outcome Type:Secondary Outcome
Measure:Efficacy Outcome - Post-operative Calls
Time Frame:participants will be followed for 48 hours after procedure
Safety Issues:False
Description:Phone calls made to surgeons regarding parental concern of post-operative pain forty-eight hours post-operatively
Outcome Type:Secondary Outcome
Measure:Outcome Measure - Number of patients with post-operative complications
Time Frame:participants will be followed for 48 hours after procedure
Safety Issues:False
Description:presence of post-operative complications

Study Interventions

Intervention Type:Procedure
Name:Ilioinguinal/iliohypogastric blockade
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.
Arm Name:Ilioinguinal/iliohypogastric blockade
Intervention Type:Procedure
Name:TAP Block
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 depos
Arm Name:TAP Block
Other Name:transversus abdominis plane block

Study Arms

Study Arm Type:Active Comparator
Arm Name:Ilioinguinal/iliohypogastric blockade
Study Arm Type:Active Comparator
Arm Name:TAP Block

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Medical Center, Cincinnati

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
Reference Type:Reference
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.
PMID:9459225
Reference Type:Reference
Citation:Fredrickson MJ, Seal P. Ultrasound-guided transversus abdominis plane block for neonatal abdominal surgery. Anaesth Intensive Care. 2009 May;37(3):469-72.
PMID:19499870
Reference Type:Reference
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.
PMID:21177284
Reference Type:Reference
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.
PMID:18768050
Reference Type:Reference
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.
PMID:19561014

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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