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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03520907
Other study ID # TFPBvsIIB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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