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

NCT ID: NCT03520907

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2019-06-27

Brief Summary

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.

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.

Conditions

Postoperative Pain; Inguinal Hernia Unilateral; Children, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Transversalis Fascia Plane Block

receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.

Group Type: EXPERIMENTAL

Transversalis Fascia Plane Block

Intervention Type: DRUG

block will be performed under real-time ultrasound guidance

Ilioinguinal/iliohypogastric Nerve Block

receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.

Group Type: ACTIVE_COMPARATOR

Ilioinguinal/iliohypogastric Nerve Block

Intervention Type: DRUG

block will be performed under real-time ultrasound guidance

Interventions

Transversalis Fascia Plane Block

block will be performed under real-time ultrasound guidance

Intervention Type: DRUG

Ilioinguinal/iliohypogastric Nerve Block

block will be performed under real-time ultrasound guidance

Intervention Type: DRUG

Other Intervention Names

TFPB; II/IH B

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kazuhiko Okuyama, MD

OTHER

Sponsor Role: lead

Responsible Party

Kazuhiko Okuyama, MD

Chief Anesthesiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kazuhiko Okuyama, MD

Role: STUDY_DIRECTOR

Ibaraki Children's Hospital

Locations

Ibaraki Children's Hospital

Mito, Ibaraki, Japan

Countries

Japan

Other Identifiers

TFPBvsIIB

Identifier Type: -

Identifier Source: org_study_id