Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05543109
• Other study ID #: 35635/8/22
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 29, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: September 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 85
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia
• Pain, Postoperative

Intervention

Drug:
• Fentanyl
1 mic/kg during induction of anesthesia
• Propofol
3mg/kg during induction of anesthesia
• Rocuronium
0.9 mg/kg during induction of anesthesia
• Sevoflurane
2-3% during maintanance of anesthesia
• Ropivacaine
0.25% Ropivacaine will be used at 1 ml/kg will be injected Ultrasound guided after induction of general anesthesia.

Locations

Country	Name	City	State
Egypt	Mona Mohamed Mogahed	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative anesthetic requirement	Intraoperative anesthetic requirement including intraoperative sevoflurane concentration and total fentanyl consumption	1 hour
Primary	Postoperative analgesic requirements	Postoperative Ketoprofen and morphine consumption	8 hours