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

Not Applicable

Completed

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

• Registration Number: NCT03520907
• Lead Sponsor: Kazuhiko Okuyama, MD

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.

Study Timeline

• Study First Submitted: 2018-04-18
• Study Start: 2018-04-26
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-11
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversalis Fascia Plane Block	Transversalis Fascia Plane Block	receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.
Ilioinguinal/iliohypogastric Nerve Block	Ilioinguinal/iliohypogastric Nerve Block	receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ibaraki Children's Hospital; 🇯🇵 Mito, Ibaraki, Japan