Congenital Hip DislocationNCT04212832
Quadratus Lumborum Block for Congenital Hip Dislocation Surgery
A study testing Bupivacaine and Standard pain in people with Congenital Hip Dislocation, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Congenital Hip Dislocation
- What is being tested?
- Bupivacaine and Standard pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2018to 15 Apr 2019
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery
Who cannot join
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
- Incomplete patient forms
Show all 9Show fewer
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- American Society of Anesthesiologist's III-IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transmuscular Quadratus Lumborum Block Block for Congenital Hip Dislocation Surgery: Randomized Controlled Study
Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain.Since initial description for abdominal surgery, the quadratus lumborum block has experienced several surgeries for postoperative pain management in adults and pediatrics. One of these indication is the hip surgery and described for adult hip arthroplasty. In addition we reported two pediatric cases that single dose transmuscular quadratus lumborum block is an affective analgesia for CHD surgery. The aim of this study was to evaluate the analgesic effect of ultrasound guided transmuscular quadratus lumborum block in pediatric patients undergoing CHD surgery.
- Conditions
- Congenital Hip Dislocation
- Being tested
- Bupivacaine, Standard pain
- Medical subject headings
- Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
0.5 ml/kg %0.25 bupivacaine
Standard painOther
Standard pain follow up and monitorization
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided quadratus lumborum block | Active comparator | ultrasound guided quadratus lumborum block with 0.5 ml/kg % 0.25 bupivacaine Receives: Drug: Bupivacaine |
| No intervention | Other | Standard Pain Followup and Monitorization Receives: Other: Standard pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face, Legs, Activity, Cry and Consolability Score (FLACC)
FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: Postoperative first 24hour
Secondary outcomes (2)
Need for rescue analgesic
Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour
Measured: 2 hour
Need for analgesic
Number of patients who required analgesic in the first 24 hour
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start15 Jun 2018
- Primary completion15 Dec 2018
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Hip DislocationStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ahiskalioglu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212832
- Sponsor's protocol ID
- AUTFANESTHESIAHIPQLB
- Status last verified
- Dec 2019
- First submitted
- 25 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahiskalioglu A, Yayik AM, Alici HA, Ezirmik N. Ultrasound guided transmuscular quadratus lumborum block for congenital hip dislocation surgery: Report of two pediatric cases. J Clin Anesth. 2018 Sep;49:15-16. doi: 10.1016/j.jclinane.2018.05.018. Epub 2018 May 26. No abstract available.
PubMed 29807213Ahiskalioglu A, Yayik AM, Alici HA. Response to Ince et al.: Ultrasound-guided quadratus lumborum plane block for congenital hip dislocation surgery: Dermatomes and osteotomes 'J Clin Anesth. 2018;54:140'. J Clin Anesth. 2019 Sep;56:39-40. doi: 10.1016/j.jclinane.2019.01.022. Epub 2019 Jan 23. No abstract available.
PubMed 30684924Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Celik EC. [Continuous quadratus lumborum type 3 block provides effective postoperative analgesia for hip surgery: case report]. Braz J Anesthesiol. 2019 Mar-Apr;69(2):208-210. doi: 10.1016/j.bjan.2018.06.007. Epub 2018 Sep 6.
PubMed 30195631Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.
PubMed 30443064
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmuscular Quadratus Lumborum Block Block for Congenital Hip Dislocation Surgery: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04212832
- Acronym / sponsor ID
- AUTFANESTHESIAHIPQLB
- Conditions
- Congenital Hip Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 30 Dec 2019 (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.
Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain.Since initial description for abdominal surgery, the quadratus lumborum block has experienced several surgeries for postoperative pain management in adults and pediatrics. One of these indication is the hip surgery and described for adult hip arthroplasty. In addition we reported two pediatric cases that single dose transmuscular quadratus lumborum block is an affective analgesia for CHD surgery. The aim of this study was to evaluate the analgesic effect of ultrasound guided transmuscular quadratus lumborum block in pediatric patients undergoing CHD surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided quadratus lumborum block | Active comparator | Drug: Bupivacaineultrasound guided quadratus lumborum block with 0.5 ml/kg % 0.25 bupivacaine |
| No intervention | Other | Other: Standard painStandard Pain Followup and Monitorization |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery
Key exclusion criteria (9 listed)
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
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 |
|---|---|---|
| Bupivacaine0.5 ml/kg %0.25 bupivacaine | Drug | ultrasound guided quadratus lumborum block |
| Standard painStandard pain follow up and monitorization | Other | No intervention |
Primary outcome
Face, Legs, Activity, Cry and Consolability Score (FLACC)
Time frame: Postoperative first 24hour
FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
2 secondary outcomes
Need for rescue analgesic
Time frame: 2 hour
Need for analgesic
Time frame: 24 hour
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 30 Dec 2019.
- Background: PubMed 29807213Ahiskalioglu A, Yayik AM, Alici HA, Ezirmik N. Ultrasound guided transmuscular quadratus lumborum block for congenital hip dislocation surgery: Report of two pediatric cases. J Clin Anesth. 2018 Sep;49:15-16. doi: 10.1016/j.jclinane.2018.05.018. Epub 2018 May 26. No abstract available.
- Background: PubMed 30684924Ahiskalioglu A, Yayik AM, Alici HA. Response to Ince et al.: Ultrasound-guided quadratus lumborum plane block for congenital hip dislocation surgery: Dermatomes and osteotomes 'J Clin Anesth. 2018;54:140'. J Clin Anesth. 2019 Sep;56:39-40. doi: 10.1016/j.jclinane.2019.01.022. Epub 2019 Jan 23. No abstract available.
- Background: PubMed 30195631Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Celik EC. [Continuous quadratus lumborum type 3 block provides effective postoperative analgesia for hip surgery: case report]. Braz J Anesthesiol. 2019 Mar-Apr;69(2):208-210. doi: 10.1016/j.bjan.2018.06.007. Epub 2018 Sep 6.
- Background: PubMed 30443064Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Standard pain in people with Congenital Hip Dislocation, run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 9 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 30 Dec 2019. 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 Turkey (Türkiye). 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?
Face, Legs, Activity, Cry and Consolability Score (FLACC) (time frame: Postoperative first 24hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04212832, which also lists 4 linked publications.
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 30 Dec 2019.