Hip OsteoarthritisNCT07327372
PENG Block With Dexmedetomidine in Older Adults
A study testing Ropivacaine 0.2% Injectable Solution and Dexmedetomidine in people with Hip Osteoarthritis and Arthropathy of Hip, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Pain after hip surgery is a common problem in older adults and may delay early mobilization, increase the need for opioid pain medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hip Osteoarthritis, Arthropathy of Hip
- What is being tested?
- Ropivacaine 0.2% Injectable Solution and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 6 Feb 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 65 years or older
- Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)
- ASA physical status I-III
- Ability to communicate pain intensity using the NRS scale
- Written informed consent obtained from the patient or legal representative
- Planned use of PENG block as part of multimodal perioperative analgesia
Who cannot join
- Patient refusal or inability to provide informed consent
- Allergy, intolerance, or contraindication to any study medication: ropivacaine, dexmedetomidine
- Pre-existing neurological deficit or neuropathy of the affected limb
- Coagulopathy (INR >1.5, platelets <100,000/µL) or current therapeutic anticoagulation that contraindicates regional anesthesia
- Infection at or near the injection site
- Severe hepatic or renal impairment
Show all 12Show fewer
- History of chronic opioid use (daily opioids >30 days before surgery)
- Cognitive impairment or delirium precluding reliable pain assessment
- BMI > 40 kg/m² (if you want to exclude for technical difficulty)
- Patients receiving another regional nerve block for hip surgery
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial within 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: Effect of Perineural Dexmedetomidine as an Adjuvant to Pericapsular Nerve Group Block in Older Adults: A Randomized Controlled Trial
Pain after hip surgery is a common problem in older adults and may delay early mobilization, increase the need for opioid pain medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Regional anesthesia techniques are increasingly used to improve pain control while reducing the use of systemic opioids.
The pericapsular nerve group (PENG) block is a modern ultrasound-guided regional anesthesia technique designed to provide effective pain relief after hip surgery while preserving muscle strength. It allows patients to begin mobilization earlier and may reduce the risk of postoperative complications, which is particularly important in older adults.
Read more
Ropivacaine is a commonly used local anesthetic for nerve blocks. Dexmedetomidine is a medication that, when added in small doses to local anesthetics, may prolong pain relief and improve the quality of nerve blocks without significantly increasing side effects. However, the benefits and safety of adding dexmedetomidine to the PENG block in older adults have not been sufficiently studied.
The aim of this randomized controlled clinical study is to compare the effectiveness and safety of two PENG block techniques in older adults undergoing hip surgery. Participants will be randomly assigned to one of two groups. One group will receive a PENG block with 20 mL of 0.2% ropivacaine. The second group will receive a PENG block with 20 mL of 0.2% ropivacaine combined with 25 micrograms of dexmedetomidine.
The study hypothesis is that the addition of dexmedetomidine to ropivacaine in the PENG block will provide longer-lasting and more effective postoperative pain relief compared with ropivacaine alone, without increasing adverse effects. Outcomes assessed in the study will include postoperative pain intensity, need for additional pain medications, time to first mobilization, and the occurrence of side effects such as low blood pressure, slow heart rate, excessive sedation, or delirium.
The results of this study may help optimize regional anesthesia techniques for hip surgery in older adults and contribute to safer, more effective postoperative pain management strategies.
Read the detailed description
Postoperative pain following hip surgery is a significant clinical problem in older adults and is associated with delayed mobilization, increased opioid consumption, higher risk of delirium, and prolonged hospitalization. Effective pain control that preserves motor function is particularly important in this population to support early rehabilitation and reduce postoperative complications.
The pericapsular nerve group (PENG) block is an ultrasound-guided regional anesthesia technique that targets the sensory innervation of the anterior hip capsule while sparing motor nerves. This technique has been shown to provide effective analgesia after hip surgery and may facilitate early postoperative mobilization. However, the duration of analgesia achieved with local anesthetics alone may be limited.
Ropivacaine is a long-acting local anesthetic commonly used for peripheral nerve blocks. Dexmedetomidine is an alpha-2 adrenergic agonist that has been used as an adjuvant to local anesthetics to prolong analgesia and improve block quality. When administered in low perineural doses, dexmedetomidine may enhance analgesic duration without causing clinically significant systemic side effects. Nevertheless, data regarding its use as an adjuvant to the PENG block in older adults are limited.
This study is designed as a prospective, randomized, controlled clinical trial comparing two PENG block regimens in older adults undergoing hip surgery. Eligible participants will be randomly assigned to one of two groups. The control group will receive a PENG block with 20 mL of 0.2% ropivacaine. The intervention group will receive a PENG block with 20 mL of 0.2% ropivacaine combined with 25 micrograms of dexmedetomidine. The PENG block will be performed under ultrasound guidance by experienced anesthesiologists according to a standardized protocol.
All participants will receive standardized general or regional anesthesia for surgery and postoperative multimodal analgesia according to institutional protocols. Postoperative pain management will be identical in both groups, except for the study intervention, to minimize confounding factors.
The primary objective of the study is to assess whether the addition of dexmedetomidine to ropivacaine prolongs and improves postoperative analgesia provided by the PENG block compared with ropivacaine alone. Secondary objectives include evaluation of postoperative pain intensity, total opioid consumption, time to first mobilization, and patient comfort.
Safety outcomes will also be assessed, with particular attention to adverse effects relevant to older adults, including hypotension, bradycardia, excessive sedation, nausea, vomiting, and postoperative delirium. Hemodynamic parameters and sedation levels will be monitored routinely in the postoperative period.
The results of this study are expected to provide clinically relevant information on the efficacy and safety of dexmedetomidine as an adjuvant to the PENG block in older adults. These findings may contribute to the optimization of regional anesthesia strategies and improved postoperative pain management in this vulnerable population.
- Conditions
- Hip Osteoarthritis, Arthropathy of Hip
- Being tested
- Ropivacaine 0.2% Injectable Solution, Dexmedetomidine
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
Also called Ropivacaine hydrochloride
Ropivacaine is a long-acting local anesthetic used for regional anesthesia. In this study, it is administered perineurally as part of an ultrasound-guided pericapsular nerve group (PENG) block for postoperative pain management in older adults undergoing hip surgery.
DexmedetomidineDrug
Also called Dexmedetomidine hydrochloride
Dexmedetomidine is a selective alpha-2 adrenergic agonist used as an adjuvant to local anesthetics to enhance and prolong analgesia. In this study, dexmedetomidine is administered perineurally in combination with ropivacaine as part of an ultrasound-guided pericapsular nerve group (PENG) block.
| Study group | Role | What they receive |
|---|---|---|
| PENG Block With Ropivacaine | Active comparator | Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block using ropivacaine 0.2%, total volume 20 mL, administered as a single perineural injection prior to surgery. The block will be performed according to a standardized protocol by an experienced anesthesiologist. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| PENG Block With Ropivacaine Plus Dexmedetomidine | Experimental | Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block using ropivacaine 0.2% (20 mL) combined with dexmedetomidine 25 micrograms, administered as a single perineural injection prior to surgery. The block will be performed according to a standardized protocol by an experienced anesthesiologist. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Rescue Analgesia
Time (in hours) from the end of the PENG block (completion of local anesthetic injection) to the first administration of rescue analgesia (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS). Data will be collected from anesthesia records and postoperative medication charts.
Measured: Within 48 hours after the end of surgery
Secondary outcomes (12)
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Measured: 4 hours after surgery
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Measured: 8 hours after surgery
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Measured: 12 hours after surgery
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Measured: 24 hours after surgery
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Measured: 48 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Measured: 4 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Measured: 8 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Measured: 12 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Measured: 24 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Measured: 48 hours after surgery
Total Opioid Consumption
Cumulative dose of all opioid analgesics administered in the postoperative period, converted to oral morphine milligram equivalents (MME). Values at 24 and 48 hours will be recorded and compared between groups.
Measured: 0-48 hours after surgery
Block-Related Adverse Events, Including Neurological Complications
Incidence of complications potentially related to the PENG block or perineural adjuvants, including signs of local anesthetic systemic toxicity, prolonged motor or sensory deficit, nerve injury (evaluated in the postoperative clinic or outpatient nerve injury clinic if required), infection at the injection site, hematoma, or persistent weakness.
Measured: From block placement until hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start6 Feb 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, MD PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327372
- Sponsor's protocol ID
- 16/2025
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 4 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perineural Dexmedetomidine as an Adjuvant to Pericapsular Nerve Group Block in Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07327372
- Acronym / sponsor ID
- 16/2025
- Conditions
- Hip Osteoarthritis, Arthropathy of Hip
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 8 Jan 2026 (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.
Pain after hip surgery is a common problem in older adults and may delay early mobilization, increase the need for opioid pain medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Regional anesthesia techniques are increasingly used to improve pain control while reducing the use of systemic opioids.
The pericapsular nerve group (PENG) block is a modern ultrasound-guided regional anesthesia technique designed to provide effective pain relief after hip surgery while preserving muscle strength. It allows patients to begin mobilization earlier and may reduce the risk of postoperative complications, which is particularly important in older adults.
Ropivacaine is a commonly used local anesthetic for nerve blocks. Dexmedetomidine is a medication that, when added in small doses to local anesthetics, may prolong pain relief and improve the quality of nerve blocks without significantly increasing side effects. However, the benefits and safety of adding dexmedetomidine to the PENG block in older adults have not been sufficiently studied.
The aim of this randomized controlled clinical study is to compare the effectiveness and safety of two PENG block techniques in older adults undergoing hip surgery. Participants will be randomly assigned to one of two groups. One group will receive a PENG block with 20 mL of 0.2% ropivacaine. The second group will receive a PENG block with 20 mL of 0.2% ropivacaine combined with 25 micrograms of dexmedetomidine.
The study hypothesis is that the addition of dexmedetomidine to ropivacaine in the PENG block will provide longer-lasting and more effective postoperative pain relief compared with ropivacaine alone, without increasing adverse effects. Outcomes assessed in the study will include postoperative pain intensity, need for additional pain medications, time to first mobilization, and the occurrence of side effects such as low blood pressure, slow heart rate, excessive sedation, or delirium.
The results of this study may help optimize regional anesthesia techniques for hip surgery in older adults and contribute to safer, more effective postoperative pain management strategies.
Detailed description
Postoperative pain following hip surgery is a significant clinical problem in older adults and is associated with delayed mobilization, increased opioid consumption, higher risk of delirium, and prolonged hospitalization. Effective pain control that preserves motor function is particularly important in this population to support early rehabilitation and reduce postoperative complications.
The pericapsular nerve group (PENG) block is an ultrasound-guided regional anesthesia technique that targets the sensory innervation of the anterior hip capsule while sparing motor nerves. This technique has been shown to provide effective analgesia after hip surgery and may facilitate early postoperative mobilization. However, the duration of analgesia achieved with local anesthetics alone may be limited.
Ropivacaine is a long-acting local anesthetic commonly used for peripheral nerve blocks. Dexmedetomidine is an alpha-2 adrenergic agonist that has been used as an adjuvant to local anesthetics to prolong analgesia and improve block quality. When administered in low perineural doses, dexmedetomidine may enhance analgesic duration without causing clinically significant systemic side effects. Nevertheless, data regarding its use as an adjuvant to the PENG block in older adults are limited.
This study is designed as a prospective, randomized, controlled clinical trial comparing two PENG block regimens in older adults undergoing hip surgery. Eligible participants will be randomly assigned to one of two groups. The control group will receive a PENG block with 20 mL of 0.2% ropivacaine. The intervention group will receive a PENG block with 20 mL of 0.2% ropivacaine combined with 25 micrograms of dexmedetomidine. The PENG block will be performed under ultrasound guidance by experienced anesthesiologists according to a standardized protocol.
All participants will receive standardized general or regional anesthesia for surgery and postoperative multimodal analgesia according to institutional protocols. Postoperative pain management will be identical in both groups, except for the study intervention, to minimize confounding factors.
The primary objective of the study is to assess whether the addition of dexmedetomidine to ropivacaine prolongs and improves postoperative analgesia provided by the PENG block compared with ropivacaine alone. Secondary objectives include evaluation of postoperative pain intensity, total opioid consumption, time to first mobilization, and patient comfort.
Safety outcomes will also be assessed, with particular attention to adverse effects relevant to older adults, including hypotension, bradycardia, excessive sedation, nausea, vomiting, and postoperative delirium. Hemodynamic parameters and sedation levels will be monitored routinely in the postoperative period.
The results of this study are expected to provide clinically relevant information on the efficacy and safety of dexmedetomidine as an adjuvant to the PENG block in older adults. These findings may contribute to the optimization of regional anesthesia strategies and improved postoperative pain management in this vulnerable population.
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 |
|---|---|---|
| PENG Block With Ropivacaine | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionParticipants will receive an ultrasound-guided pericapsular nerve group (PENG) block using ropivacaine 0.2%, total volume 20 mL, administered as a single perineural injection prior to surgery. The block will be performed according to a standardized protocol by an experienced anesthesiologist. |
| PENG Block With Ropivacaine Plus Dexmedetomidine | Experimental | Drug: DexmedetomidineParticipants will receive an ultrasound-guided pericapsular nerve group (PENG) block using ropivacaine 0.2% (20 mL) combined with dexmedetomidine 25 micrograms, administered as a single perineural injection prior to surgery. The block will be performed according to a standardized protocol by an experienced anesthesiologist. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 years or older
- Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)
- ASA physical status I-III
- Ability to communicate pain intensity using the NRS scale
- Written informed consent obtained from the patient or legal representative
Key exclusion criteria (12 listed)
- Patient refusal or inability to provide informed consent
- Allergy, intolerance, or contraindication to any study medication: ropivacaine, dexmedetomidine
- Pre-existing neurological deficit or neuropathy of the affected limb
- Coagulopathy (INR >1.5, platelets <100,000/µL) or current therapeutic anticoagulation that contraindicates regional anesthesia
- Infection at or near the injection site
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 |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionAlso: Ropivacaine hydrochlorideRopivacaine is a long-acting local anesthetic used for regional anesthesia. In this study, it is administered perineurally as part of an ultrasound-guided pericapsular nerve group (PENG) block for postoperative pain management in older adults undergoing hip surgery. | Drug | PENG Block With Ropivacaine |
| DexmedetomidineAlso: Dexmedetomidine hydrochlorideDexmedetomidine is a selective alpha-2 adrenergic agonist used as an adjuvant to local anesthetics to enhance and prolong analgesia. In this study, dexmedetomidine is administered perineurally in combination with ropivacaine as part of an ultrasound-guided pericapsular nerve group (PENG) block. | Drug | PENG Block With Ropivacaine Plus Dexmedetomidine |
Primary outcome
Time to First Rescue Analgesia
Time frame: Within 48 hours after the end of surgery
Time (in hours) from the end of the PENG block (completion of local anesthetic injection) to the first administration of rescue analgesia (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS). Data will be collected from anesthesia records and postoperative medication charts.
12 secondary outcomes
Pain Intensity at Rest (NRS 0-10)
Time frame: 4 hours after surgery
Pain Intensity at Rest (NRS 0-10)
Time frame: 8 hours after surgery
Pain Intensity at Rest (NRS 0-10)
Time frame: 12 hours after surgery
Pain Intensity at Rest (NRS 0-10)
Time frame: 24 hours after surgery
Pain Intensity at Rest (NRS 0-10)
Time frame: 48 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Time frame: 4 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Time frame: 8 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Time frame: 12 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Time frame: 24 hours after surgery
Pain Intensity During Movement (NRS 0-10)
Time frame: 48 hours after surgery
Total Opioid Consumption
Time frame: 0-48 hours after surgery
Block-Related Adverse Events, Including Neurological Complications
Time frame: From block placement until hospital discharge, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
Malgorzata Reysner, MD PhD study chair
Poznan 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 study testing Ropivacaine 0.2% Injectable Solution and Dexmedetomidine in people with Hip Osteoarthritis and Arthropathy of Hip, 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 4 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malgorzata Reysner, MD PhD (+48 61 873 83 03, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Rescue Analgesia (time frame: Within 48 hours after the end of 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 4 Mar 2026.