Ultrasound Quadratus Lumborum Block Vs Fascia Iliaca Block in Pediatrics Undergoing Hip Surgery .

April 8, 2022 updated by: Sherif Mohamed Abd El Moneim Soaida, MD, Cairo University

Ultrasound Guided Quadratus Lumborum Block Versus Fascia Iliaca Block in Pediatric Patients Undergoing Developmental Dysplasia of Hip Surgical Repair. A Randomized Comparative Study

Comparison between ultrasound guided transmuscular QL block and Fascia iliaca block in pediatric patients undergoing DDH surgery regarding the quality of pain control in the perioperative period..

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of medicine cairo university
        • Contact:
          • Sherif M. Soaida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 2-12 years
  • Of both sexes
  • American society of anesthesiologist (ASA) physical status classification class I
  • Undergoing general anaesthesia for DDH surgery

Exclusion Criteria:

  • Parents' refusal of regional block
  • Duration of surgery over 120 min.
  • History of allergy to local anesthetics
  • Bleeding disorders (INR >1.4, Platelet count< 75000)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group F: ultrasound guided fascia iliaca block group
Procedure: ultrasound guided fascia iliaca block
ultrasound guided fascia iliaca block anesthetizes variable combinations of the femoral nerve , lateral femoral cutaneous nerve , and obturator nerve, and is effective for many painful hip surgeries making it potentially useful for analgesia following Developmental Dysplasia of Hip (DDH) surgery.
Active Comparator: Group Q: ultrasound guided quadratus lumborum block group
Procedure: ultrasound guided quadratus lumborum block
ultrasound-guided quadratus lumborum (QL) block provides perioperative somatic, even visceral analgesia for patients including pediatrics, undergoing abdominal or hip surgery. The local anesthetic injected adjacently into the quadrates lumborum muscle spreads in a medial and cranial direction under the crura and arcuate ligaments of the diaphragm, then into the thoracic paravertebral space anesthetizing the hip region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total 12 hours postoperative opioid consumption
Time Frame: from the time of transfer of the patient to the pacu at one hour intervals for 12 hours
amount of morphine consumed as rescue analgesia in first 12 hours
from the time of transfer of the patient to the pacu at one hour intervals for 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain using Face, Legs, Activity, Cry, Consolability scale (FLACC ) pain rating scale
Time Frame: from the time of transfer to the PACU, every hour for the first 24 hours postoperative]
pain score of paitients in the post operative period
from the time of transfer to the PACU, every hour for the first 24 hours postoperative]
Side effects
Time Frame: from the time of transfer to the PACU, for the first 24 hours postoperative
respiratory depression and postoperative nausea and vomiting
from the time of transfer to the PACU, for the first 24 hours postoperative
Total 24 hours postoperative opioid consumption
Time Frame: from the time of transfer of the patient to the pacu at one hour intervals for 24hours
amount of morphine consumed as rescue analgesia in first 24hours
from the time of transfer of the patient to the pacu at one hour intervals for 24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 15, 2022

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMS2022-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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