NCT04998071

Brief Summary

The aim of the present study is to evaluate and compare the analgesic efficiency of the difference concentration between 0.125% and 0.25% bupivacaine provided by ultrasound guided posterior quadratus lumborum block undergoing LPEC in children

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

July 9, 2021

Last Update Submit

August 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of postoperative analgesia

    Postoperative pain score as CHEOPs SCORE

    24 hours after surgery

Secondary Outcomes (1)

  • Incidence of complications

    12 hours after surgery

Study Arms (2)

ROUTINE DRUG - CONCENTRATION QLB

ACTIVE COMPARATOR

The patients will receive bilateral posterior quadratus lumborum block using 0.25% bupivacaine 0.4 ml/kg. in each side.

Drug: Bupivacaine hydrochloride

ALTERNATIVE DRUG - CONCENTRATION QLB

ACTIVE COMPARATOR

The patients will receive bilateral posterior quadratus lumborum block using 0.125% bupivacaine 0.4 ml/kg. in each side.

Drug: Bupivacaine hydrochloride

Interventions

Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC

ALTERNATIVE DRUG - CONCENTRATION QLBROUTINE DRUG - CONCENTRATION QLB

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children scheduled for laparoscopic percutaneous extraperitoneal closure(LPEC) for pediatric inguinal hernia and hydrocele
  • ASA I-II physical status patients
  • Complete inform consent for intervention

You may not qualify if:

  • Contraindication for regional anesthesia
  • Sensitive to local anesthetic agent, opioid or acetaminophen
  • Previous history of abdominal surgery
  • History of neuromuscular disease
  • G6PD deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • SUWITCHA TAMRONGCHOTE, MD

    Queen Sirikit National Institute of Child Health (QSNICH)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SUWITCHA TAMRONGCHOTE, MD

CONTACT

NUTTAPHONG LEPANANON, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Queen Sirikit National Institute of Child Health

Study Record Dates

First Submitted

July 9, 2021

First Posted

August 10, 2021

Study Start

August 15, 2021

Primary Completion

May 31, 2022

Study Completion

June 30, 2022

Last Updated

August 10, 2021

Record last verified: 2021-08

Locations