Hip Dislocation, CongenitalNCT04292782
Quadratus Lumborum Block for Pediatric Hip Surgery
A study testing anterior Quadratus lumborum block and caudal block in people with Hip Dislocation, Congenital and Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Caudal blockade (CB) is one of the most frequently performed regional anaesthetic techniques in children. It's an efficient way to offer perioperative analgesia for painful sub-umbilical interventions but with high incidence of motor block and urinary retention. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Hip Dislocation, Congenital, Postoperative Pain, Anesthesia
- What is being tested?
- anterior Quadratus lumborum block and caudal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTunisia
- Study dates
- 31 Mar 2020to 31 Dec 2021
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 2 to 7 years old
- Weight ≤ 20 Kg
- American Society of Anesthesiologists (ASA) physical status I or II
- Planned to undergo unilateral open hip reduction/osteotomies
Who cannot join
- Cerebral palsy with severe intellectual disability
- Coagulation disorders
- Local or general infection
- Allergy to amide local anesthetics.
- Progressive neurological disorders
- Parenteral refusal
- Spinal dysraphism
- Cutaneous anomalies (angioma, hair truft, naevus or a dimple)near to the puncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caudal Epidural Block Compared to Anterior Quadratus Lumborum Block for Pediatric Hip Surgery
Caudal blockade (CB) is one of the most frequently performed regional anaesthetic techniques in children. It's an efficient way to offer perioperative analgesia for painful sub-umbilical interventions but with high incidence of motor block and urinary retention. In one study, psoas compartment block was associated with less morphine comsumption and prolonged duration of analgesia compared to single-shot caudal Block in small children undergoing open hip reduction/osteotomies. Ultasound guided anterior Quadratus lumborum block (AQLB) provides unilateral analgesia to the nerves between the psoas muscle (PM) and the quadratus lumborum muscle (QLM). The first pediatric study evaluating Quadratus lumborum block is encouraging .
The first pediatric study evaluating Quadratus lumborum block is encouraging. To the best of the investigator's knowledge, there are no previously published data comparing the AQLB with other regional techniques in infants undergoing hip surgery.
Read the detailed description
The aim of this prospective randomized study was to compare the analgesic effects between AQLB and CB in children undergoing unilateral open hip reduction/osteotomies for hip dislocation.
Patients were randomly assigned, into 1 of 2 groups, namely, group CB (n = 20) and group AQLB (n = 20).
Preoperatively all children were premedicated by using oral midazolam (0 .5mg/kg).
anesthesia was induced with 3 to 4% sevoflurane and 50% with 60% nitrous oxide in oxygen.Then fentanyl 3 μg/kg and Propofol 1 - 2mg/Kg were administered for anesthesia induction. Airway was secured with endotracheal tube placed in the mouth facilited by 0.15 mg/kg cistracurium. Anesthesia maintenance was performed with sevoflurane 2% in 50% nitrous oxide.
AQLB and CB were done with 1 ml/kg, 0.25% Ropivacaine (maximum dose limited to 20 ml)
Postoperative follow-up:
All patients received 15 mg/kg paracetamol before extubation. Tramadol 2 mg/kg intravenous was planned as rescue analgesia when CHEOPS score was more than 3. Supplemental IV tramado, 1 mg/kg could be added if necessary every 6 hours.
- Conditions
- Hip Dislocation, Congenital, Postoperative Pain, Anesthesia
- Being tested
- anterior Quadratus lumborum block, caudal block
- Keywords
- hip dislocation, regional anesthesia, surgery
- Medical subject headings
- Hip Dislocation, Congenital, Pain, Postoperative, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior Quadratus lumborum blockProcedure or surgery
ultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine
caudal blockProcedure or surgery
ultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| CAUDAL BLOCK | Active comparator | Sonosite machine (M-Turbo) equipped with a large bandwidth, a multifrequency linear probe (6-19 MHz) and needle of diameter and length respectively between 22G and 25G, 35mm and 40mm according to the child's size (Braun).The patient is positioned laterally with their hips flexed to 90°. The sacral hiatus is forming with the two posterior superior iliac spines an equilateral triangle. The puncture is performed between the two sacral cornuae. The sacrococcygeal ligament gives a perceptible 'pop' when crossed. After crossing the sacro-coccygeal ligament, the needle is redirected 30° to the skin surface, and then advanced a few millimeters into sacral canal. After verifying absence of spontaneous reflux of blood or cerebrospinal fluid, slowly injection of Ropivacaine 0.25% 1ml/ kg Receives: Procedure: caudal block |
| anterior Quadratus lumborum block | Experimental | Sonosite machine (M-Turbo) equipped with a large bandwidth, a multifrequency linear probe (6-19 MHz) and a 22G, 50-mm, insulated facet type needle (BBraun Stimuplex Ultra 360°). Patients were placed in the lateral position, a probe was placed transversely to the abdominal flank. The needle was inserted using an in-plane technique and was preceded further into the fascia between the QLM and PM. Following confirmation of the correct space with the administration of 0.5-1 ml local anesthetic, block was induced with 1 ml/kg, 0.25% Ropivacaine, Receives: Procedure: anterior Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesics consumption
total tramadol consumption
Measured: day one
Secondary outcomes (2)
postoperative pain score
Children's Hospital Eastern Ontario Pain Scale (CHEOPS) [4=no pain ; 13=worst pain]
Measured: day one
analgesic rescue
time to first analgesic rescue
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start31 Mar 2020
- Primary completion30 Mar 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Dislocation, CongenitalStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Kassab d'Orthopédie
- Responsible party
- Principal investigator, Olfa kaabachi, MD, University Tunis El Manar
- Investigators
- khaireddine Raddaoui, MD, Principal investigator, Tunis El Manar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292782
- Sponsor's protocol ID
- CE-IMKO 104/2019
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Epidural Block Compared to Anterior Quadratus Lumborum Block for Pediatric Hip Surgery
- ClinicalTrials.gov ID
- NCT04292782
- Acronym / sponsor ID
- CE-IMKO 104/2019
- Conditions
- Hip Dislocation, Congenital, Postoperative Pain, Anesthesia
- Keywords
- hip dislocation, regional anesthesia, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Collaborators
- Institut Kassab d'Orthopédie
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Mar 2020 (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.
Caudal blockade (CB) is one of the most frequently performed regional anaesthetic techniques in children. It's an efficient way to offer perioperative analgesia for painful sub-umbilical interventions but with high incidence of motor block and urinary retention. In one study, psoas compartment block was associated with less morphine comsumption and prolonged duration of analgesia compared to single-shot caudal Block in small children undergoing open hip reduction/osteotomies. Ultasound guided anterior Quadratus lumborum block (AQLB) provides unilateral analgesia to the nerves between the psoas muscle (PM) and the quadratus lumborum muscle (QLM). The first pediatric study evaluating Quadratus lumborum block is encouraging .
The first pediatric study evaluating Quadratus lumborum block is encouraging. To the best of the investigator's knowledge, there are no previously published data comparing the AQLB with other regional techniques in infants undergoing hip surgery.
Detailed description
The aim of this prospective randomized study was to compare the analgesic effects between AQLB and CB in children undergoing unilateral open hip reduction/osteotomies for hip dislocation.
Patients were randomly assigned, into 1 of 2 groups, namely, group CB (n = 20) and group AQLB (n = 20).
Preoperatively all children were premedicated by using oral midazolam (0 .5mg/kg).
anesthesia was induced with 3 to 4% sevoflurane and 50% with 60% nitrous oxide in oxygen.Then fentanyl 3 μg/kg and Propofol 1 - 2mg/Kg were administered for anesthesia induction. Airway was secured with endotracheal tube placed in the mouth facilited by 0.15 mg/kg cistracurium. Anesthesia maintenance was performed with sevoflurane 2% in 50% nitrous oxide.
AQLB and CB were done with 1 ml/kg, 0.25% Ropivacaine (maximum dose limited to 20 ml)
Postoperative follow-up:
All patients received 15 mg/kg paracetamol before extubation. Tramadol 2 mg/kg intravenous was planned as rescue analgesia when CHEOPS score was more than 3. Supplemental IV tramado, 1 mg/kg could be added if necessary every 6 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAUDAL BLOCK | Active comparator | Procedure: caudal blockSonosite machine (M-Turbo) equipped with a large bandwidth, a multifrequency linear probe (6-19 MHz) and needle of diameter and length respectively between 22G and 25G, 35mm and 40mm according to the child's size (Braun).The patient is positioned laterally with their hips flexed to 90°. The sacral hiatus is forming with the two posterior superior iliac spines an equilateral triangle. The puncture is performed between the two sacral cornuae. The sacrococcygeal ligament gives a perceptible 'pop' when crossed. After crossing the sacro-coccygeal ligament, the needle is redirected 30° to the skin surface, and then advanced a few millimeters into sacral canal. After verifying absence of spontaneous reflux of blood or cerebrospinal fluid, slowly injection of Ropivacaine 0.25% 1ml/ kg |
| anterior Quadratus lumborum block | Experimental | Procedure: anterior Quadratus lumborum blockSonosite machine (M-Turbo) equipped with a large bandwidth, a multifrequency linear probe (6-19 MHz) and a 22G, 50-mm, insulated facet type needle (BBraun Stimuplex Ultra 360°). Patients were placed in the lateral position, a probe was placed transversely to the abdominal flank. The needle was inserted using an in-plane technique and was preceded further into the fascia between the QLM and PM. Following confirmation of the correct space with the administration of 0.5-1 ml local anesthetic, block was induced with 1 ml/kg, 0.25% Ropivacaine, |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients aged 2 to 7 years old
- Weight ≤ 20 Kg
- American Society of Anesthesiologists (ASA) physical status I or II
- Planned to undergo unilateral open hip reduction/osteotomies
Key exclusion criteria (8 listed)
- Cerebral palsy with severe intellectual disability
- Coagulation disorders
- Local or general infection
- Allergy to amide local anesthetics.
- Progressive neurological disorders
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 |
|---|---|---|
| anterior Quadratus lumborum blockultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine | Procedure or surgery | anterior Quadratus lumborum block |
| caudal blockultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine | Procedure or surgery | CAUDAL BLOCK |
Primary outcome
analgesics consumption
Time frame: day one
total tramadol consumption
2 secondary outcomes
postoperative pain score
Time frame: day one
analgesic rescue
Time frame: Day one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
khaireddine Raddaoui, MD principal investigator
Tunis El Manar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior Quadratus lumborum block and caudal block in people with Hip Dislocation, Congenital and Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
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 8 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesics consumption (time frame: day one). 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 13 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.