The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block

The Effect of the Transversalis Fascia Plane Block on Postoperative Pain Behavior After Hernia Repair Surgery in Children - Comparison With Conventional Ilioinguinal/Iliohypogastric Nerve Block-

This study compares the transversalis fascia plane block with the ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery.

Half of participants will receive the transversalis fascia plane block, while the other will receive the ilioinguinal/iliohypogastric nerve block.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Children, Only; Inguinal Hernia Unilateral
• Intervention / Treatment: Drug: Transversalis Fascia Plane Block; Drug: Ilioinguinal/iliohypogastric Nerve Block

Detailed Description

The ilioinguinal/iliohypogastric nerve block (II/IH B)is a widely used regional anesthesia technique in inguinal hernia repair surgery. However, this block provides limited analgesia during and after surgery, and the patients feel pain when walking. The transversalis fascia plane block (TFPB) is a recently developed technique and several case reports presented its efficacy for inguinal repair surgery in adult patients. It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the thoracolumbar fascia. Therefore, we compare the effect of the TFPB and II/IH B on postoperative pain and walking form.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Ibaraki
    • Mito, Ibaraki, Japan, 311-4145
      • Ibaraki Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• the patients undergoing unilateral open hernia repair surgery

Exclusion Criteria:

• known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transversalis Fascia Plane Block; receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.	Drug: Transversalis Fascia Plane Block; block will be performed under real-time ultrasound guidance; Other Names: TFPB
ACTIVE_COMPARATOR: Ilioinguinal/iliohypogastric Nerve Block; receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.	Drug: Ilioinguinal/iliohypogastric Nerve Block; block will be performed under real-time ultrasound guidance; Other Names: II/IH B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
walking appearance	scoring a way of walking; 0: brisk walk, big step, able to skip (= no pain) to 5: not able to stand up ( = worst pain)	3 to 5 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC (face, legs, activity, cry, consolability) score	behavioral pain scale in children. Each category has 0 to 2 score; Total 0 (no pain) to 10 (worst)	3 to 5 hours after surgery
Faces Pain Scale revised	self-reported pain score. Children choose a face from six faces.	3 to 5 hours after surgery
additional pain curer usage	request or necessity of administration of acetaminophen or flurbiprofen	up to 5 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative heart rate changes	heart rate during surgery	just before surgery start, one minute after incision, maximum value during surgery
intraoperative respiratory rate changes	respiratory rate during surgery	just before surgery start, one minute after incision, maximum value during surgery

Collaborators and Investigators

• Sponsor: Kazuhiko Okuyama, MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2018
• Primary Completion (ACTUAL): June 27, 2019
• Study Completion (ACTUAL): June 27, 2019

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (ACTUAL): May 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: children; inguinal hernia repair; transversalis fascia; ilioinguinal/iliohypogastric nerve
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Pain, Postoperative; Hernia; Hernia, Inguinal
• Other Study ID Numbers: TFPBvsIIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No