Congenital Hip DysplasiaNCT04212039
Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery
A study testing Saline Solution and Bupivacaine in people with Congenital Hip Dysplasia, 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 Dysplasia
- What is being tested?
- Saline Solution and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Sep 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 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: Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind 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. Pericapsular nerve group (PENG) block has been recently recommended for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia method based on blocking the articular branches of femoral nerve (FN) and accessory obturator nerve (AON) in the region between the anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE).The aim of this study was to evaluate the analgesic effect of ultrasound guided pediatric pericapsular nerve group (PENG) block in pediatric patients undergoing CHD surgery.
- Conditions
- Congenital Hip Dysplasia
- Being tested
- Saline Solution, Bupivacaine
- 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.
Saline SolutionDrug
0.5 ml/kg saline
BupivacaineDrug
0.5 ml/kg %0.25 bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided pericapsular nerve group block | Active comparator | Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection between to iliopubic eminentia and psoas tendon Receives: Drug: Bupivacaine |
| ultrasound guided sham block | Sham comparator | Ultrasound guided 0.5 ml/kg saline injection injection between to iliopubic eminentia and psoas tendon Receives: Drug: Saline Solution |
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 posted26 Dec 2019
- Study start1 Jan 2020
- Primary completion1 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congenital Hip DysplasiaStudies 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
- 48 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
- NCT04212039
- Sponsor's protocol ID
- AUTFANESTHESIAHIP
- Status last verified
- Sep 2022
- First submitted
- 24 Dec 2019
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aksu C, Cesur S, Kus A. Pericapsular nerve group (PENG) block for postoperative analgesia after open reduction of pediatric congenital dysplasia of the hip. J Clin Anesth. 2020 May;61:109675. doi: 10.1016/j.jclinane.2019.109675. Epub 2019 Dec 1. No abstract available.
PubMed 31796372Ahiskalioglu A, Aydin ME, Celik M, Ahiskalioglu EO, Tulgar S. Can high volume pericapsular nerve group (PENG) block act as a lumbar plexus block? J Clin Anesth. 2020 May;61:109650. doi: 10.1016/j.jclinane.2019.109650. Epub 2019 Nov 12. No abstract available.
PubMed 31732426Orozco S, Munoz D, Jaramillo S, Herrera AM. Pediatric use of Pericapsular Nerve Group (PENG) block for hip surgical procedures. J Clin Anesth. 2019 Nov;57:143-144. doi: 10.1016/j.jclinane.2019.04.010. Epub 2019 Apr 22. No abstract available.
PubMed 31022606Ahiskalioglu A, Aydin ME, Ahiskalioglu EO, Tuncer K, Celik M. Pericapsular nerve group (PENG) block for surgical anesthesia of medial thigh. J Clin Anesth. 2020 Feb;59:42-43. doi: 10.1016/j.jclinane.2019.06.021. Epub 2019 Jun 15. No abstract available.
PubMed 31212123Ahiskalioglu A, Aydin ME, Ozkaya F, Ahiskalioglu EO, Adanur S. A novel indication of Pericapsular Nerve Group (PENG) block: Prevention of adductor muscle spasm. J Clin Anesth. 2020 Mar;60:51-52. doi: 10.1016/j.jclinane.2019.08.034. Epub 2019 Aug 21. No abstract available.
PubMed 31445179
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT04212039
- Acronym / sponsor ID
- AUTFANESTHESIAHIP
- Conditions
- Congenital Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 26 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. Pericapsular nerve group (PENG) block has been recently recommended for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia method based on blocking the articular branches of femoral nerve (FN) and accessory obturator nerve (AON) in the region between the anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE).The aim of this study was to evaluate the analgesic effect of ultrasound guided pediatric pericapsular nerve group (PENG) block in pediatric patients undergoing CHD surgery.
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 |
|---|---|---|
| ultrasound guided pericapsular nerve group block | Active comparator | Drug: BupivacaineUltrasound guided 0.5 ml/kg % 0.250 bupivacaine injection between to iliopubic eminentia and psoas tendon |
| ultrasound guided sham block | Sham comparator | Drug: Saline SolutionUltrasound guided 0.5 ml/kg saline injection injection between to iliopubic eminentia and psoas tendon |
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 |
|---|---|---|
| Saline Solution0.5 ml/kg saline | Drug | ultrasound guided sham block |
| Bupivacaine0.5 ml/kg %0.25 bupivacaine | Drug | ultrasound guided pericapsular nerve group block |
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 13 Sep 2022.
- Background: PubMed 31796372Aksu C, Cesur S, Kus A. Pericapsular nerve group (PENG) block for postoperative analgesia after open reduction of pediatric congenital dysplasia of the hip. J Clin Anesth. 2020 May;61:109675. doi: 10.1016/j.jclinane.2019.109675. Epub 2019 Dec 1. No abstract available.
- Background: PubMed 31732426Ahiskalioglu A, Aydin ME, Celik M, Ahiskalioglu EO, Tulgar S. Can high volume pericapsular nerve group (PENG) block act as a lumbar plexus block? J Clin Anesth. 2020 May;61:109650. doi: 10.1016/j.jclinane.2019.109650. Epub 2019 Nov 12. No abstract available.
- Background: PubMed 31022606Orozco S, Munoz D, Jaramillo S, Herrera AM. Pediatric use of Pericapsular Nerve Group (PENG) block for hip surgical procedures. J Clin Anesth. 2019 Nov;57:143-144. doi: 10.1016/j.jclinane.2019.04.010. Epub 2019 Apr 22. No abstract available.
- Background: PubMed 31212123Ahiskalioglu A, Aydin ME, Ahiskalioglu EO, Tuncer K, Celik M. Pericapsular nerve group (PENG) block for surgical anesthesia of medial thigh. J Clin Anesth. 2020 Feb;59:42-43. doi: 10.1016/j.jclinane.2019.06.021. Epub 2019 Jun 15. No abstract available.
- Background: PubMed 31445179Ahiskalioglu A, Aydin ME, Ozkaya F, Ahiskalioglu EO, Adanur S. A novel indication of Pericapsular Nerve Group (PENG) block: Prevention of adductor muscle spasm. J Clin Anesth. 2020 Mar;60:51-52. doi: 10.1016/j.jclinane.2019.08.034. Epub 2019 Aug 21. No abstract available.
- 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.
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 Saline Solution and Bupivacaine in people with Congenital Hip Dysplasia, 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 13 Sep 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 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. Some participants in this study may receive a placebo. 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 NCT04212039, which also lists 5 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 13 Sep 2022.