Arthropathy of HipTHANCT07584200
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
A study testing Intrathecal Morphine, Pericapsular Nerve Group Block and Dexamethasone in people with Arthropathy of Hip and Hip Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Arthropathy of Hip, Hip Osteoarthritis
- What is being tested?
- Intrathecal Morphine, Pericapsular Nerve Group Block and Dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 7 May 2026to 1 May 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 60 to 100 years
- Scheduled for elective total hip arthroplasty
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone
- Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks
- Infection at the site of spinal or peripheral nerve block injection
- Pre-existing neurological disorders affecting sensory or motor function
- Severe hepatic or renal insufficiency
- Chronic opioid use for more than 3 months prior to surgery
- Refusal or inability to provide informed consent
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: Comparison of the Efficacy and Safety of Three Regional Anesthesia Strategies in Patients Undergoing Elective Total Hip Arthroplasty: A Prospective, Randomized, Multicenter Clinical Trial
The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty.
The main questions this study aims to answer are:
Read more
Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone.
Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation.
The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.
Read the detailed description
Postoperative pain after total hip arthroplasty is associated with increased opioid use, delayed mobilization, and a higher risk of adverse events, particularly in older adults. Spinal anesthesia with intrathecal morphine is widely used to improve postoperative analgesia; however, it may be associated with opioid-related side effects such as nausea, pruritus, urinary retention, and respiratory depression. Ultrasound-guided regional nerve blocks, including the pericapsular nerve group (PENG) block, have emerged as opioid-sparing alternatives that may provide effective analgesia while preserving motor function.
This prospective, randomized, multicenter clinical trial is designed to compare the efficacy and safety of three regional anesthesia strategies in patients undergoing elective total hip arthroplasty. Participants aged 60 years and older will be randomly assigned in a 1:1:1 ratio to one of three study groups: spinal anesthesia with intrathecal morphine; spinal anesthesia combined with a PENG block; or spinal anesthesia combined with a PENG block using perineural dexamethasone as an adjuvant.
All participants will receive standardized spinal anesthesia with ropivacaine. In the control group, intrathecal morphine will be administered as part of routine spinal anesthesia. In the intervention groups, the PENG block will be performed under ultrasound guidance using ropivacaine, with or without the addition of dexamethasone. Perioperative care, postoperative analgesic protocols, and rehabilitation pathways will be standardized across all study centers to minimize variability.
The primary outcome is total postoperative opioid consumption during the first 48 hours after surgery, expressed as intravenous morphine equivalents. Secondary outcomes include pain intensity at rest and during movement assessed using the Numeric Rating Scale (NRS) at 6, 12, 24, and 48 hours after surgery, time to first rescue analgesia, early mobilization, length of hospital stay, and incidence of opioid-related adverse events.
The results of this study will provide comparative evidence on opioid-based versus opioid-sparing regional anesthesia strategies for hip arthroplasty and may help inform clinical decision-making aimed at improving postoperative pain control, functional recovery, and safety in older surgical patients.
- Conditions
- Arthropathy of Hip, Hip Osteoarthritis
- Being tested
- Intrathecal Morphine, Pericapsular Nerve Group Block, Dexamethasone
- Keywords
- total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
Also called Morphine (intrathecal)
Intrathecal morphine administered as part of spinal anesthesia for postoperative pain control during elective total hip arthroplasty.
Pericapsular Nerve Group BlockProcedure or surgery
Also called PENG Block
Ultrasound-guided pericapsular nerve group block performed as an adjunct to spinal anesthesia to provide postoperative analgesia.
DexamethasoneDrug
Also called Dexamethasone (perineural)
Perineural dexamethasone administered as an adjuvant to the pericapsular nerve group block to prolong postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia With Intrathecal Morphine | Active comparator | Participants will receive spinal anesthesia with intrathecal ropivacaine combined with intrathecal morphine. Ropivacaine 0.5% (10-15 mg) will be administered intrathecally, followed by intrathecal morphine at a dose of 100 micrograms as part of standard anesthesia care. Receives: Drug: Intrathecal Morphine |
| Spinal Anesthesia Plus PENG Block | Experimental | Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% administered as a single injection. Receives: Procedure: Pericapsular Nerve Group Block |
| Spinal Anesthesia Plus PENG Block With Dexamethasone | Experimental | Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% with the addition of dexamethasone 4 mg administered perineurally as a single injection. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Opioid Consumption
Total amount of opioids administered postoperatively, expressed as intravenous morphine equivalents.
Measured: Up to 48 hours after surgery
Secondary outcomes (12)
Pain scores at rest
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 6 hours after surgery
Pain scores durring movement
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 6 hours after surgery
Pain scores at rest
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 12 hours after surgery
Pain scores durring movement
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 12 hours after surgery
Pain scores at rest
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 24 hours after surgery
Pain scores durring movement
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 24 hours after surgery
Pain scores at rest
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 48 hours after surgery
Pain scores durring movement
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 48 hours after surgery
Time to First Rescue Analgesia
Time from the end of surgery to the first request for rescue analgesic medication.
Measured: Up to 48 hours after surgery.
Early Mobilization
Time to first mobilization assessed using the Timed Up and Go test.
Measured: Up to 48 hours after surgery
Incidence of Opioid-Related Adverse Events
Occurrence of opioid-related adverse events, including nausea, vomiting, pruritus, and urinary retention.
Measured: Up to 48 hours after surgery.
Length of Hospital Stay
Total duration of postoperative hospitalization measured in days.
Measured: measured at the day of the discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start7 May 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584200
- Sponsor's protocol ID
- 1/2026
- Acronym
- THA
- Status last verified
- Nov 2026
- First submitted
- 13 Mar 2026
- Last updated
- 5 Nov 2026
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Three Regional Anesthesia Strategies in Patients Undergoing Elective Total Hip Arthroplasty: A Prospective, Randomized, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07584200
- Acronym / sponsor ID
- THA / 1/2026
- Conditions
- Arthropathy of Hip, Hip Osteoarthritis
- Keywords
- total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 13 May 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.
The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty.
The main questions this study aims to answer are:
Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone.
Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation.
The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.
Detailed description
Postoperative pain after total hip arthroplasty is associated with increased opioid use, delayed mobilization, and a higher risk of adverse events, particularly in older adults. Spinal anesthesia with intrathecal morphine is widely used to improve postoperative analgesia; however, it may be associated with opioid-related side effects such as nausea, pruritus, urinary retention, and respiratory depression. Ultrasound-guided regional nerve blocks, including the pericapsular nerve group (PENG) block, have emerged as opioid-sparing alternatives that may provide effective analgesia while preserving motor function.
This prospective, randomized, multicenter clinical trial is designed to compare the efficacy and safety of three regional anesthesia strategies in patients undergoing elective total hip arthroplasty. Participants aged 60 years and older will be randomly assigned in a 1:1:1 ratio to one of three study groups: spinal anesthesia with intrathecal morphine; spinal anesthesia combined with a PENG block; or spinal anesthesia combined with a PENG block using perineural dexamethasone as an adjuvant.
All participants will receive standardized spinal anesthesia with ropivacaine. In the control group, intrathecal morphine will be administered as part of routine spinal anesthesia. In the intervention groups, the PENG block will be performed under ultrasound guidance using ropivacaine, with or without the addition of dexamethasone. Perioperative care, postoperative analgesic protocols, and rehabilitation pathways will be standardized across all study centers to minimize variability.
The primary outcome is total postoperative opioid consumption during the first 48 hours after surgery, expressed as intravenous morphine equivalents. Secondary outcomes include pain intensity at rest and during movement assessed using the Numeric Rating Scale (NRS) at 6, 12, 24, and 48 hours after surgery, time to first rescue analgesia, early mobilization, length of hospital stay, and incidence of opioid-related adverse events.
The results of this study will provide comparative evidence on opioid-based versus opioid-sparing regional anesthesia strategies for hip arthroplasty and may help inform clinical decision-making aimed at improving postoperative pain control, functional recovery, and safety in older surgical patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia With Intrathecal Morphine | Active comparator | Drug: Intrathecal MorphineParticipants will receive spinal anesthesia with intrathecal ropivacaine combined with intrathecal morphine. Ropivacaine 0.5% (10-15 mg) will be administered intrathecally, followed by intrathecal morphine at a dose of 100 micrograms as part of standard anesthesia care. |
| Spinal Anesthesia Plus PENG Block | Experimental | Procedure: Pericapsular Nerve Group BlockParticipants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% administered as a single injection. |
| Spinal Anesthesia Plus PENG Block With Dexamethasone | Experimental | Drug: DexamethasoneParticipants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% with the addition of dexamethasone 4 mg administered perineurally as a single injection. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 60 to 100 years
- Scheduled for elective total hip arthroplasty
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (7 listed)
- Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone
- Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks
- Infection at the site of spinal or peripheral nerve block injection
- Pre-existing neurological disorders affecting sensory or motor function
- Severe hepatic or renal insufficiency
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 |
|---|---|---|
| Intrathecal MorphineAlso: Morphine (intrathecal)Intrathecal morphine administered as part of spinal anesthesia for postoperative pain control during elective total hip arthroplasty. | Drug | Spinal Anesthesia With Intrathecal Morphine |
| Pericapsular Nerve Group BlockAlso: PENG BlockUltrasound-guided pericapsular nerve group block performed as an adjunct to spinal anesthesia to provide postoperative analgesia. | Procedure or surgery | Spinal Anesthesia Plus PENG Block |
| DexamethasoneAlso: Dexamethasone (perineural)Perineural dexamethasone administered as an adjuvant to the pericapsular nerve group block to prolong postoperative analgesia. | Drug | Spinal Anesthesia Plus PENG Block With Dexamethasone |
Primary outcome
Total Postoperative Opioid Consumption
Time frame: Up to 48 hours after surgery
Total amount of opioids administered postoperatively, expressed as intravenous morphine equivalents.
12 secondary outcomes
Pain scores at rest
Time frame: 6 hours after surgery
Pain scores durring movement
Time frame: 6 hours after surgery
Pain scores at rest
Time frame: 12 hours after surgery
Pain scores durring movement
Time frame: 12 hours after surgery
Pain scores at rest
Time frame: 24 hours after surgery
Pain scores durring movement
Time frame: 24 hours after surgery
Pain scores at rest
Time frame: 48 hours after surgery
Pain scores durring movement
Time frame: 48 hours after surgery
Time to First Rescue Analgesia
Time frame: Up to 48 hours after surgery.
Early Mobilization
Time frame: Up to 48 hours after surgery
Incidence of Opioid-Related Adverse Events
Time frame: Up to 48 hours after surgery.
Length of Hospital Stay
Time frame: measured at the day of the discharge from the hospital
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 5 Nov 2026.
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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
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 study testing Intrathecal Morphine, Pericapsular Nerve Group Block and Dexamethasone in people with Arthropathy of Hip and Hip Osteoarthritis, 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 7 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 5 Nov 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 Reysenr, MD PhD (608762068, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Postoperative Opioid Consumption (time frame: Up to 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 5 Nov 2026.