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

NCT03520907 | Completed

• 1 other identifier: TFPBvsIIB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Inguinal Hernia Unilateral; Children, Only

Keywords

transversalis fascia; ilioinguinal/iliohypogastric nerve; inguinal hernia repair; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• FLACC (face, legs, activity, cry, consolability) score

  3 to 5 hours after surgery

• Faces Pain Scale revised

  3 to 5 hours after surgery

• additional pain curer usage

  up to 5 hours after surgery

Other Outcomes (2)

• intraoperative heart rate changes

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

• intraoperative respiratory rate changes

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

Study Arms (2)

Transversalis Fascia Plane Block

EXPERIMENTAL

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

Drug: Transversalis Fascia Plane Block

Ilioinguinal/iliohypogastric Nerve Block

ACTIVE COMPARATOR

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

Drug: Ilioinguinal/iliohypogastric Nerve Block

Interventions

Transversalis Fascia Plane Block DRUG

block will be performed under real-time ultrasound guidance

Also known as: TFPB

Transversalis Fascia Plane Block

Ilioinguinal/iliohypogastric Nerve Block DRUG

block will be performed under real-time ultrasound guidance

Also known as: II/IH B

Ilioinguinal/iliohypogastric Nerve Block

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• the patients undergoing unilateral open hernia repair surgery

You may not qualify if:

• known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage

Sponsors & Collaborators

• Kazuhiko Okuyama, MD: lead

Study Sites (1)

Ibaraki Children's Hospital

Mito, Ibaraki, 311-4145, Japan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kazuhiko Okuyama, MD

  Ibaraki Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Anesthesiologist

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 11, 2018
• Study Start: April 26, 2018
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)