Back to resultsUltrasound Quadratus Lumborum Block Vs Fascia Iliaca Block in Pediatrics Undergoing Hip Surgery .
Primary Purpose
Developmental Dysplasia of the Hip
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided fascia iliaca block
ultrasound guided quadratus lumborum block
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Dysplasia of the Hip focused on measuring ultrasound, quadratus lumborum, fascia iliaca
Eligibility Criteria
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)
Sites / Locations
- Faculty of medicine Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group F: ultrasound guided fascia iliaca block group
Group Q: ultrasound guided quadratus lumborum block group
Arm Description
Outcomes
Primary Outcome Measures
Total 12 hours postoperative opioid consumption
amount of morphine consumed as rescue analgesia in first 12 hours
Secondary Outcome Measures
Postoperative pain using Face, Legs, Activity, Cry, Consolability scale (FLACC ) pain rating scale
pain score of paitients in the post operative period
Side effects
respiratory depression and postoperative nausea and vomiting
Total 24 hours postoperative opioid consumption
amount of morphine consumed as rescue analgesia in first 24hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05282849
Brief Title
Ultrasound Quadratus Lumborum Block Vs Fascia Iliaca Block in Pediatrics Undergoing Hip Surgery .
Official Title
Ultrasound Guided Quadratus Lumborum Block Versus Fascia Iliaca Block in Pediatric Patients Undergoing Developmental Dysplasia of Hip Surgical Repair. A Randomized Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dysplasia of the Hip
Keywords
ultrasound, quadratus lumborum, fascia iliaca
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group F: ultrasound guided fascia iliaca block group
Arm Type
Active Comparator
Arm Title
Group Q: ultrasound guided quadratus lumborum block group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided fascia iliaca block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided quadratus lumborum block
Intervention Description
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
Primary Outcome Measure Information:
Title
Total 12 hours postoperative opioid consumption
Description
amount of morphine consumed as rescue analgesia in first 12 hours
Time Frame
from the time of transfer of the patient to the pacu at one hour intervals for 12 hours
Secondary Outcome Measure Information:
Title
Postoperative pain using Face, Legs, Activity, Cry, Consolability scale (FLACC ) pain rating scale
Description
pain score of paitients in the post operative period
Time Frame
from the time of transfer to the PACU, every hour for the first 24 hours postoperative]
Title
Side effects
Description
respiratory depression and postoperative nausea and vomiting
Time Frame
from the time of transfer to the PACU, for the first 24 hours postoperative
Title
Total 24 hours postoperative opioid consumption
Description
amount of morphine consumed as rescue analgesia in first 24hours
Time Frame
from the time of transfer of the patient to the pacu at one hour intervals for 24hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif M. Soaida, MD
Phone
+201223663504
Email
sherif_soaida@kasralainy.edu.eg
Facility Information:
Facility Name
Faculty of medicine Cairo university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherif M. Soaida
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Ultrasound Quadratus Lumborum Block Vs Fascia Iliaca Block in Pediatrics Undergoing Hip Surgery .
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