search
Back to results

Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block

Primary Purpose

Pain, Postoperative, Hip Dysplasia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fentanyl
Propofol
Rocuronium
Sevoflurane
Ropivacaine
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mona Mohamed Mogahed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Psoas compartment block

Suprainguinal fascia iliaca compartment block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intraoperative anesthetic requirement
Intraoperative anesthetic requirement including intraoperative sevoflurane concentration and total fentanyl consumption
Postoperative analgesic requirements
Postoperative Ketoprofen and morphine consumption

Secondary Outcome Measures

Full Information

First Posted
September 13, 2022
Last Updated
September 29, 2022
Sponsor
Tanta University
search

1. Study Identification

Unique Protocol Identification Number
NCT05543109
Brief Title
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 29, 2022 (Anticipated)
Primary Completion Date
February 10, 2023 (Anticipated)
Study Completion Date
February 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Hip Dysplasia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psoas compartment block
Arm Type
Active Comparator
Arm Description
After induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg.
Arm Title
Suprainguinal fascia iliaca compartment block
Arm Type
Active Comparator
Arm Description
After induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Narcotic
Intervention Description
1 mic/kg during induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Intravenous anesthetic
Intervention Description
3mg/kg during induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Muscle relaxant
Intervention Description
0.9 mg/kg during induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Inhalational anesthetic
Intervention Description
2-3% during maintanance of anesthesia
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Local anesthetic
Intervention Description
0.25% Ropivacaine will be used at 1 ml/kg will be injected Ultrasound guided after induction of general anesthesia.
Primary Outcome Measure Information:
Title
Intraoperative anesthetic requirement
Description
Intraoperative anesthetic requirement including intraoperative sevoflurane concentration and total fentanyl consumption
Time Frame
1 hour
Title
Postoperative analgesic requirements
Description
Postoperative Ketoprofen and morphine consumption
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mona Mohamed Mogahed
City
Tanta
State/Province
Elgharbia
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block

We'll reach out to this number within 24 hrs