Hip DysplasiaPhase 4NCT06789367
The Effect of Dexamethasone Administration Route in PENG Block for Pediatric Hip Surgery
A Phase 4 study testing perineural Dexamethasone 4mg and intravenous Dexamethsone 4mg in people with Hip Dysplasia and Hip Disease, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain, inflammatory response, and neuromonitoring parameters in pediatric patients undergoing hip surgery. Read more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- Hip Dysplasia, Hip Disease
- What is being tested?
- perineural Dexamethasone 4mg and intravenous Dexamethsone 4mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2025to 3 Mar 2026
- Phase
- Phase 4
- 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 3 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children scheduled for hip surgery
- body weight > 5kg
Who cannot join
- infection at the site of the regional block,
- coagulation disorders,
- immunodeficiency,
- American Society of Anesthesiologists (ASA) physical status of IV or higher,
- history of regular steroid medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Pediatric Hip Surgery
This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain, inflammatory response, and neuromonitoring parameters in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate pain scale at multiple time intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time to first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric hip surgery.
Read the detailed description
Pediatric hip surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes. The pericapsular nerve group (PENG) block is a regional anesthesia technique that offers targeted analgesia for hip procedures while preserving motor function, making it particularly suitable for pediatric patients.
Dexamethasone is commonly used as an adjuvant in regional anesthesia to prolong analgesia and mitigate inflammation. However, the optimal administration route of dexamethasone in the context of PENG block for pediatric hip surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses.
This prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the PENG block. All patients will receive standardized general anesthesia and PENG block using a local anesthetic at a fixed concentration.
The primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels. The study will also monitor neuromonitoring parameters during surgery to ensure patient safety and evaluate the influence of dexamethasone on neurological outcomes.
Safety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.
- Conditions
- Hip Dysplasia, Hip Disease
- Being tested
- perineural Dexamethasone 4mg, intravenous Dexamethsone 4mg
- Keywords
- pericapsular nerve group block, PENG block, dexamethasone, adjuvant
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineural Dexamethasone 4mgDrug
PENG block with 0.5ml/kg 0.2% ropivacaine + 0,1mgkg perineural Dexamethasone
intravenous Dexamethsone 4mgDrug
PENG block with 0,5ml/kg 0.2% ropivacaine + 0,1mg/kg intravenous Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| perinerual dexamethasone | Active comparator | PENG block + perineural dexamethasone Receives: Drug: perineural Dexamethasone 4mg |
| intravenous dexamethasone | Active comparator | PENG block + intravenous dexamethasone Receives: Drug: intravenous Dexamethsone 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue opioid analgesia
Time to first rescue opioid analgesia
Measured: 48 hours after surgery
Secondary outcomes (18)
Total opioid consumption
Total opioid consumption in milliequivalents of morphine
Measured: 48 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: 4 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: 8 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: 12 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: 24 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: 48 hours after surgery
Nerve damage
Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome
Measured: 12 hours after surgery
Nerve damage
Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome
Measured: 24 hours after surgery
Nerve damage
Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome
Measured: 48 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Measured: 12 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Measured: 24 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Measured: 48 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Measured: 12 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Measured: 24 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Measured: 48 hours after surgery
glucose
blood glucose levels
Measured: 12 hours after surgery
glucose
blood glucose levels
Measured: 24 hours after surgery
glucose
blood glucose levels
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Feb 2025
- Primary completion14 Feb 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, M.D. Ph.D., Study chair, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789367
- Sponsor's protocol ID
- 3/2025
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Pediatric Hip Surgery
- ClinicalTrials.gov ID
- NCT06789367
- Acronym / sponsor ID
- 3/2025
- Conditions
- Hip Dysplasia, Hip Disease
- Keywords
- pericapsular nerve group block, PENG block, dexamethasone, adjuvant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 14 Feb 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 23 Jan 2025 (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.
This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain, inflammatory response, and neuromonitoring parameters in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate pain scale at multiple time intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time to first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric hip surgery.
Detailed description
Pediatric hip surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes. The pericapsular nerve group (PENG) block is a regional anesthesia technique that offers targeted analgesia for hip procedures while preserving motor function, making it particularly suitable for pediatric patients.
Dexamethasone is commonly used as an adjuvant in regional anesthesia to prolong analgesia and mitigate inflammation. However, the optimal administration route of dexamethasone in the context of PENG block for pediatric hip surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses.
This prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the PENG block. All patients will receive standardized general anesthesia and PENG block using a local anesthetic at a fixed concentration.
The primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels. The study will also monitor neuromonitoring parameters during surgery to ensure patient safety and evaluate the influence of dexamethasone on neurological outcomes.
Safety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perinerual dexamethasone | Active comparator | Drug: perineural Dexamethasone 4mgPENG block + perineural dexamethasone |
| intravenous dexamethasone | Active comparator | Drug: intravenous Dexamethsone 4mgPENG block + intravenous dexamethasone |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children scheduled for hip surgery
- body weight > 5kg
Key exclusion criteria (5 listed)
- infection at the site of the regional block,
- coagulation disorders,
- immunodeficiency,
- American Society of Anesthesiologists (ASA) physical status of IV or higher,
- history of regular steroid medication.
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 |
|---|---|---|
| perineural Dexamethasone 4mgPENG block with 0.5ml/kg 0.2% ropivacaine + 0,1mgkg perineural Dexamethasone | Drug | perinerual dexamethasone |
| intravenous Dexamethsone 4mgPENG block with 0,5ml/kg 0.2% ropivacaine + 0,1mg/kg intravenous Dexamethasone | Drug | intravenous dexamethasone |
Primary outcome
Time to first rescue opioid analgesia
Time frame: 48 hours after surgery
Time to first rescue opioid analgesia
18 secondary outcomes
Total opioid consumption
Time frame: 48 hours after surgery
NRS
Time frame: 4 hours after surgery
NRS
Time frame: 8 hours after surgery
NRS
Time frame: 12 hours after surgery
NRS
Time frame: 24 hours after surgery
NRS
Time frame: 48 hours after surgery
Nerve damage
Time frame: 12 hours after surgery
Nerve damage
Time frame: 24 hours after surgery
Nerve damage
Time frame: 48 hours after surgery
NLR
Time frame: 12 hours after surgery
NLR
Time frame: 24 hours after surgery
NLR
Time frame: 48 hours after surgery
PLR
Time frame: 12 hours after surgery
PLR
Time frame: 24 hours after surgery
PLR
Time frame: 48 hours after surgery
glucose
Time frame: 12 hours after surgery
glucose
Time frame: 24 hours after surgery
glucose
Time frame: 48 hours after surgery
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 16 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
Malgorzata Reysner, M.D. Ph.D. study chair
Poznań University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing perineural Dexamethasone 4mg and intravenous Dexamethsone 4mg in people with Hip Dysplasia and Hip Disease, run by Poznan University of Medical Sciences at 1 site in Poland.
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 2 inclusion and 5 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 16 Mar 2026. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first rescue opioid analgesia (time frame: 48 hours after surgery). 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 16 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.