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
About this trial
This is an interventional other trial for Pain, Postoperative
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.
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
NCT ID
NCT05543109
First Posted
September 13, 2022
Last Updated
September 29, 2022
Sponsor
Tanta University
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
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Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
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