Developmental Dysplasia of the HipNCT05282849
Ultrasound Quadratus Lumborum Block Vs Fascia Iliaca Block in Pediatrics Undergoing Hip Surgery .
A study testing ultrasound guided fascia iliaca block and ultrasound guided quadratus lumborum block in people with Developmental Dysplasia of the Hip, run by Cairo University at 1 site in Egypt.
Trial 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.. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- ultrasound guided fascia iliaca block and ultrasound guided quadratus lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2022to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-12 years
- Of both sexes
- American society of anesthesiologist (ASA) physical status classification class I
- Undergoing general anaesthesia for DDH surgery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine Cairo university
Cairo
Sherif M. Soaida
About this study
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
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..
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- ultrasound guided fascia iliaca block, ultrasound guided quadratus lumborum block
- Keywords
- ultrasound, quadratus lumborum, fascia iliaca
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided fascia iliaca blockProcedure or surgery
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.
ultrasound guided quadratus lumborum blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Group F: ultrasound guided fascia iliaca block group | Active comparator | Not described Receives: Procedure: ultrasound guided fascia iliaca block |
| Group Q: ultrasound guided quadratus lumborum block group | Active comparator | Not described Receives: Procedure: ultrasound guided quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 12 hours postoperative opioid consumption
amount of morphine consumed as rescue analgesia in first 12 hours
Measured: from the time of transfer of the patient to the pacu at one hour intervals for 12 hours
Secondary outcomes (3)
Postoperative pain using Face, Legs, Activity, Cry, Consolability scale (FLACC ) pain rating scale
pain score of paitients in the post operative period
Measured: from the time of transfer to the PACU, every hour for the first 24 hours postoperative]
Side effects
respiratory depression and postoperative nausea and vomiting
Measured: from the time of transfer to the PACU, for the first 24 hours postoperative
Total 24 hours postoperative opioid consumption
amount of morphine consumed as rescue analgesia in first 24hours
Measured: from the time of transfer of the patient to the pacu at one hour intervals for 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start4 Apr 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Mohamed Abd El Moneim Soaida, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282849
- Sponsor's protocol ID
- SMS2022-1
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05282849
- Acronym / sponsor ID
- SMS2022-1
- Conditions
- Developmental Dysplasia of the Hip
- Keywords
- ultrasound, quadratus lumborum, fascia iliaca
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F: ultrasound guided fascia iliaca block group | Active comparator | Procedure: ultrasound guided fascia iliaca block |
| Group Q: ultrasound guided quadratus lumborum block group | Active comparator | Procedure: ultrasound guided quadratus lumborum block |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 2-12 years
- Of both sexes
- American society of anesthesiologist (ASA) physical status classification class I
- Undergoing general anaesthesia for DDH surgery
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided fascia iliaca blockultrasound 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. | Procedure or surgery | Group F: ultrasound guided fascia iliaca block group |
| ultrasound guided quadratus lumborum blockultrasound-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 | Procedure or surgery | Group Q: ultrasound guided quadratus lumborum block group |
Primary outcome
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
3 secondary outcomes
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]
Side effects
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided fascia iliaca block and ultrasound guided quadratus lumborum block in people with Developmental Dysplasia of the Hip, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif M. Soaida, MD (+201223663504, sherif_soaida@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.