Osteoarthritis, HipPhase 4NCT06789328
The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Total Hip Arthroplasty
A Phase 4 study testing perineural Dexamethasone 4mg and intravenous Dexamethsone 4mg in people with Osteoarthritis, Hip and Hip Pain Chronic, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This study aims to evaluate the effect of the dexamethasone administration route (intravenous vs. perineural) on postoperative pain, inflammatory response, and clinical outcomes in patients undergoing total hip arthroplasty (THA) with a pericapsular nerve group (PENG) block. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Osteoarthritis, Hip, Hip Pain Chronic, Hip Arthropathy
- 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 11 Jul 2025
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients scheduled for total hip arthroplasty
- patients aged >65 and <100 years
- patients able to provide informed consent
- patients able to reliably report symptoms to the research team
Who cannot join
- inability to provide first-party consent due to cognitive impairment or a language barrier
- 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
This study aims to evaluate the effect of the dexamethasone administration route (intravenous vs. perineural) on postoperative pain, inflammatory response, and clinical outcomes in patients undergoing total hip arthroplasty (THA) with a pericapsular nerve group (PENG) block. The primary outcome is the intensity of postoperative pain measured using the numerical rating scale (NRS) at rest and during movement. Secondary outcomes include the inflammatory response assessed by neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, and patient satisfaction. The findings from this study may contribute to optimizing anesthesia protocols and improving postoperative recovery in patients undergoing THA.
Read the detailed description
Total hip arthroplasty (THA) is a common orthopedic procedure associated with significant postoperative pain and inflammation, which can impact recovery and long-term outcomes. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block, have become increasingly popular for pain management in THA due to their ability to provide effective analgesia while preserving motor function.
Dexamethasone is frequently used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce inflammation. However, there is limited evidence comparing the efficacy of different administration routes of dexamethasone (intravenous vs. perineural) in the context of PENG block. Additionally, understanding the impact of dexamethasone on postoperative pain, inflammatory markers, and overall patient recovery is crucial for optimizing clinical protocols.
This study is a prospective, randomized, double-blinded trial involving patients undergoing elective THA. Participants will be randomly assigned to two groups: the IV dexamethasone group or the perineural dexamethasone group. Both groups will receive standardized general anesthesia and PENG block with local anesthetic. Postoperative pain will be assessed using the NRS at various time intervals (e.g., 6, 12, 24, and 48 hours postoperatively) at rest and during movement. NLR and PLR will measure the inflammatory response from blood samples taken preoperatively and 24 hours postoperatively.
The primary outcome is time first to request rescue analgesia. Secondary outcomes include cumulative opioid consumption, length of hospital stay, and patient satisfaction. Safety and potential complications, such as local anesthetic systemic toxicity (LAST), will be closely monitored.
The results of this study may provide valuable insights into the optimal use of dexamethasone as an adjuvant in regional anesthesia for THA, potentially improving pain management, reducing opioid use, and enhancing postoperative recovery.
- Conditions
- Osteoarthritis, Hip, Hip Pain Chronic, Hip Arthropathy, Hip Arthritis
- Being tested
- perineural Dexamethasone 4mg, intravenous Dexamethsone 4mg
- Keywords
- pericapsular nerve group block, PENG block, adjuvant, dexamethasone
- Medical subject headings
- Osteoarthritis, Hip
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 20ml 0.2% ropivacaine + 4mg perineural Dexamethasone
intravenous Dexamethsone 4mgDrug
PENG block with 20ml 0.2% ropivacaine + 4mg intravenous Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Perineural 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 (23)
Total opioid consumption
Total opioid consumption (mg) converted to morphine milligram equivalents (MME)
Measured: 48 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 4 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 8 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 12 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 24 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 48 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Measured: 12 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Measured: 24 hours after surgery
NLR
Neutrophil-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
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Measured: 4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Measured: 8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Measured: 12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Measured: 24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Measured: 48 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale:
N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Measured: 12 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale:
N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Measured: 24 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale:
N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Measured: 48 hours after surgery
glucose
blood glucose level
Measured: 12 hours after surgery
glucose
blood glucose level
Measured: 24 hours after surgery
glucose
blood glucose level
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 completion30 Jun 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- NCT06789328
- Sponsor's protocol ID
- 2/2025
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. 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 Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06789328
- Acronym / sponsor ID
- 2/2025
- Conditions
- Osteoarthritis, Hip, Hip Pain Chronic, Hip Arthropathy, Hip Arthritis
- Keywords
- pericapsular nerve group block, PENG block, adjuvant, dexamethasone
- 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
- 30 Jun 2025 (actual)
- Study completion
- 11 Jul 2025 (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 evaluate the effect of the dexamethasone administration route (intravenous vs. perineural) on postoperative pain, inflammatory response, and clinical outcomes in patients undergoing total hip arthroplasty (THA) with a pericapsular nerve group (PENG) block. The primary outcome is the intensity of postoperative pain measured using the numerical rating scale (NRS) at rest and during movement. Secondary outcomes include the inflammatory response assessed by neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, and patient satisfaction. The findings from this study may contribute to optimizing anesthesia protocols and improving postoperative recovery in patients undergoing THA.
Detailed description
Total hip arthroplasty (THA) is a common orthopedic procedure associated with significant postoperative pain and inflammation, which can impact recovery and long-term outcomes. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block, have become increasingly popular for pain management in THA due to their ability to provide effective analgesia while preserving motor function.
Dexamethasone is frequently used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce inflammation. However, there is limited evidence comparing the efficacy of different administration routes of dexamethasone (intravenous vs. perineural) in the context of PENG block. Additionally, understanding the impact of dexamethasone on postoperative pain, inflammatory markers, and overall patient recovery is crucial for optimizing clinical protocols.
This study is a prospective, randomized, double-blinded trial involving patients undergoing elective THA. Participants will be randomly assigned to two groups: the IV dexamethasone group or the perineural dexamethasone group. Both groups will receive standardized general anesthesia and PENG block with local anesthetic. Postoperative pain will be assessed using the NRS at various time intervals (e.g., 6, 12, 24, and 48 hours postoperatively) at rest and during movement. NLR and PLR will measure the inflammatory response from blood samples taken preoperatively and 24 hours postoperatively.
The primary outcome is time first to request rescue analgesia. Secondary outcomes include cumulative opioid consumption, length of hospital stay, and patient satisfaction. Safety and potential complications, such as local anesthetic systemic toxicity (LAST), will be closely monitored.
The results of this study may provide valuable insights into the optimal use of dexamethasone as an adjuvant in regional anesthesia for THA, potentially improving pain management, reducing opioid use, and enhancing postoperative recovery.
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 |
|---|---|---|
| Perineural 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
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patients scheduled for total hip arthroplasty
- patients aged >65 and <100 years
- patients able to provide informed consent
- patients able to reliably report symptoms to the research team
Key exclusion criteria (6 listed)
- inability to provide first-party consent due to cognitive impairment or a language barrier
- infection at the site of the regional block,
- coagulation disorders,
- immunodeficiency,
- American Society of Anesthesiologists (ASA) physical status of IV or higher,
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 20ml 0.2% ropivacaine + 4mg perineural Dexamethasone | Drug | Perineural dexamethasone |
| intravenous Dexamethsone 4mgPENG block with 20ml 0.2% ropivacaine + 4mg 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
23 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
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
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
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
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 23 Jul 2025.
Related trials for Osteoarthritis, Hip
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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 Osteoarthritis, Hip and Hip Pain Chronic, 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 4 inclusion and 6 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 23 Jul 2025. 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 23 Jul 2025.