Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain, Postoperative; Hip Dysplasia
• Intervention / Treatment: Drug: Fentanyl; Drug: Propofol; Drug: Rocuronium; Drug: Sevoflurane; Drug: Ropivacaine

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 Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt, 31511
      • Mona Mohamed Mogahed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 29, 2022
• Primary Completion (Anticipated): February 10, 2023
• Study Completion (Anticipated): February 10, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Pain, Postoperative; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Platelet Aggregation Inhibitors; Analgesics, Opioid; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Anesthetics; Fentanyl; Propofol; Sevoflurane; Anesthetics, Local; Ropivacaine; Rocuronium; Anesthetics, Intravenous; Narcotics
• Other Study ID Numbers: 35635/8/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No