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NCT Number: NCT03520907

The Comparison of the Transversalis Fascia Plane Block With 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.

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Key information

Conditions

Postoperative Pain Children, Only Inguinal Hernia Unilateral Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ibaraki Children's Hospital

Mito, Ibaraki, 311-4145, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transversalis Fascia Plane Block

Drug

block will be performed under real-time ultrasound guidance

Other names: TFPB

Ilioinguinal/iliohypogastric Nerve Block

Drug

block will be performed under real-time ultrasound guidance

Other names: II/IH B

Primary outcomes

  1. walking appearance

    Time frame: 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 outcomes

  1. FLACC (face, legs, activity, cry, consolability) score

    Time frame: 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)

  2. Faces Pain Scale revised

    Time frame: 3 to 5 hours after surgery

    self-reported pain score. Children choose a face from six faces.

  3. additional pain curer usage

    Time frame: up to 5 hours after surgery

    request or necessity of administration of acetaminophen or flurbiprofen

Other outcomes

  1. intraoperative heart rate changes

    Time frame: just before surgery start, one minute after incision, maximum value during surgery

    heart rate during surgery

  2. intraoperative respiratory rate changes

    Time frame: just before surgery start, one minute after incision, maximum value during surgery

    respiratory rate during surgery

Sponsors and collaborators

Lead sponsor

Kazuhiko Okuyama, MD

Other

Registry information

Official study title

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-

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 11, 2018
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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