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

Postoperative Pain Clinical Trial

Official 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-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520907
• Other study ID #: TFPBvsIIB
• Status: Completed
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: August 2019
• Source: Ibaraki Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Hernia
• Hernia, Inguinal
• Inguinal Hernia Unilateral
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Transversalis Fascia Plane Block
block will be performed under real-time ultrasound guidance
• Ilioinguinal/iliohypogastric Nerve Block
block will be performed under real-time ultrasound guidance

Locations

Country	Name	City	State
Japan	Ibaraki Children's Hospital	Mito	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Kazuhiko Okuyama, MD

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intraoperative heart rate changes	heart rate during surgery	just before surgery start, one minute after incision, maximum value during surgery
Other	intraoperative respiratory rate changes	respiratory rate during surgery	just before surgery start, one minute after incision, maximum value during surgery
Primary	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	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
Secondary	Faces Pain Scale revised	self-reported pain score. Children choose a face from six faces.	3 to 5 hours after surgery
Secondary	additional pain curer usage	request or necessity of administration of acetaminophen or flurbiprofen	up to 5 hours after surgery