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Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block

Sponsor
Tanta University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05543109
Collaborator
(none)
85
Enrollment
1
Location
2
Arms
5
Anticipated Duration (Months)
16.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

All subjects after entering operation room will be connected to standard monitor electrocardiograph, non-invasive blood pressure, heart rate, oxygen saturation.

Three mg/kg of propofol, 0.2 μg/kg of fentanyl and 0.1 mg/kg midazolam will be used for sedation. Oxygen at the concentration of 100% will be administrated under the mask in all patients after satisfactory sedation, tracheal intubation will be performed after intravenous anesthesia with administration of 3 mg/kg of propofol, 0.6 μg/kg of fentanyl and 0.9 mg/kg of rocurium. After intubation 2-3% of sevoflurane and 0.2-0.3 mcg/kg/min of fentanyl will be used to maintain anesthesia guided by PSI and hemodynamic monitoring.

The two groups will receive nerve block with local anesthetics. In the SFIB group, the patients will receive ultrasound-guided SFIB, while the patients in the PCB group will receive PCB under the guidance of ultrasound.

Local anesthetic 0.25% Ropivacaine will be used at 1 ml/kg for SFIB and PCB. (the dose of local anesthetic for SFIB or PCB was not more than 35ml). All blocks will be performed by the same experienced anesthesiologist.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block for Pain Management in Pediatric Patients With Developmental Dysplasia Sia of the Hip Joint, Randomized Controlled Trial
Anticipated Study Start Date :
Sep 10, 2022
Anticipated Primary Completion Date :
Feb 10, 2023
Anticipated Study Completion Date :
Feb 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Psoas compartment block

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

Drug: Fentanyl
1 mic/kg during induction of anesthesia
Other Names:
  • Narcotic

    • Drug: Propofol
    3mg/kg during induction of anesthesia
    Other Names:
  • Intravenous anesthetic

    • Drug: Rocuronium
    0.9 mg/kg during induction of anesthesia
    Other Names:
  • Muscle relaxant

    • Drug: Sevoflurane
    2-3% during maintanance of anesthesia
    Other Names:
  • Inhalational anesthetic

    • Drug: Ropivacaine
    0.25% Ropivacaine will be used at 1 ml/kg will be injected Ultrasound guided after induction of general anesthesia.
    Other Names:
  • Local anesthetic

    		•
    Active Comparator: Suprainguinal fascia iliaca compartment block

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

    Drug: Fentanyl
    1 mic/kg during induction of anesthesia
    Other Names:
  • Narcotic

    • Drug: Propofol
    3mg/kg during induction of anesthesia
    Other Names:
  • Intravenous anesthetic

    • Drug: Rocuronium
    0.9 mg/kg during induction of anesthesia
    Other Names:
  • Muscle relaxant

    • Drug: Sevoflurane
    2-3% during maintanance of anesthesia
    Other Names:
  • Inhalational anesthetic

    • Drug: Ropivacaine
    0.25% Ropivacaine will be used at 1 ml/kg will be injected Ultrasound guided after induction of general anesthesia.
    Other Names:
  • Local anesthetic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraoperative anesthetic requirement [1 hour]

      Intraoperative anesthetic requirement including intraoperative sevoflurane concentration and total fentanyl consumption

    2. Postoperative analgesic requirements [8 hours]

      Postoperative Ketoprofen and morphine consumption

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing undergo acetabuloplasty

    • Anesthesiologists (ASA) physical status of I to II

    Exclusion Criteria:

    • Known allergy to local anesthetic

    • Infection at the block site.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mona Mohamed Mogahed Tanta Elgharbia Egypt 31511

    Sponsors and Collaborators

    • Tanta University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mona Mohamed Mogahed, Associate professor, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05543109
    Other Study ID Numbers:
    • 35635/8/22
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hip Dislocation
    Developmental Dysplasia of the Hip
    Hip Dislocation, Congenital
    Pain, Postoperative
    Fentanyl
    Narcotics
    Propofol
    Anesthetics, Intravenous
    Ropivacaine
    Anesthetics
    Sevoflurane
    Anesthetics, Local
    Rocuronium

    Study Results

    No Results Posted as of Sep 16, 2022