NCT05543109

Brief Summary

The aim of this study was to compare the intraoperative and the postoperative analgesic effect of psoas compartment block (PCB) and supra-inguinal fascia iliaca compartment block (SFIB) in pediatric patients undergoing developmental dysplasia of the hip

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
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

September 29, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

September 13, 2022

Last Update Submit

September 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Intraoperative anesthetic requirement

    Intraoperative anesthetic requirement including intraoperative sevoflurane concentration and total fentanyl consumption

    1 hour

  • Postoperative analgesic requirements

    Postoperative Ketoprofen and morphine consumption

    8 hours

Study Arms (2)

Psoas compartment block

ACTIVE COMPARATOR

After induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg.

Drug: FentanylDrug: PropofolDrug: RocuroniumDrug: SevofluraneDrug: Ropivacaine

Suprainguinal fascia iliaca compartment block

ACTIVE COMPARATOR

After induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg.

Drug: FentanylDrug: PropofolDrug: RocuroniumDrug: SevofluraneDrug: Ropivacaine

Interventions

1 mic/kg during induction of anesthesia

Also known as: Narcotic
Psoas compartment blockSuprainguinal fascia iliaca compartment block

3mg/kg during induction of anesthesia

Also known as: Intravenous anesthetic
Psoas compartment blockSuprainguinal fascia iliaca compartment block

0.9 mg/kg during induction of anesthesia

Also known as: Muscle relaxant
Psoas compartment blockSuprainguinal fascia iliaca compartment block

2-3% during maintanance of anesthesia

Also known as: Inhalational anesthetic
Psoas compartment blockSuprainguinal fascia iliaca compartment block

0.25% Ropivacaine will be used at 1 ml/kg will be injected Ultrasound guided after induction of general anesthesia.

Also known as: Local anesthetic
Psoas compartment blockSuprainguinal fascia iliaca compartment block

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients undergoing undergo acetabuloplasty
  • Anesthesiologists (ASA) physical status of I to II

You may not qualify if:

  • Known allergy to local anesthetic
  • Infection at the block site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mona Mohamed Mogahed

Tanta, Elgharbia, 31511, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativeHip Dislocation

Interventions

FentanylNarcoticsPropofolAnesthetics, IntravenousRocuroniumSevofluraneRopivacaineAnesthetics, Local

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnesthetics, GeneralAnestheticsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

September 29, 2022

Primary Completion

February 10, 2023

Study Completion

February 10, 2023

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations