Hip OsteoarthritisPhase 4NCT07180979
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
A Phase 4 study testing Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.2% Injectable Solution in people with Hip Osteoarthritis and Hip Arthropathy, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic
- What is being tested?
- Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 15 Sep 2025to 30 Nov 2026
- Phase
- Phase 4
- 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
- ASA physical status I-III
- Elective unilateral THA via posterior or lateral approach
- Informed consent provided
Who cannot join
- Allergy to study drugs (ropivacaine, dexamethasone)
- Chronic opioid use (>30 MME/day)
- Coagulopathy or infection at the injection site
- BMI > 40 kg/m²
- Pre-existing motor weakness or neuropathy in the affected limb
- Cognitive impairment precluding 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 Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block (L-ESPB) Combined With Sacral ESPB (S-ESPB) for Analgesia in Total Hip Arthroplasty (THA): A Randomized Clinical Trial
The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery.
The main questions it aims to answer are:
Read more
Does the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique? Which method provides better pain relief, preserves muscle strength, and supports earlier mobilization? Researchers will compare the Pericapsular Nerve Group (PENG) block with the combination of Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB + S-ESPB) to see which provides better pain control, fewer side effects, and faster recovery.
Participants will:
Be randomly assigned to receive one of the two types of ultrasound-guided regional anesthesia Undergo standard hip replacement surgery under spinal anesthesia Be monitored for pain scores, opioid use, time to first walking, muscle strength, satisfaction, and side effects over the first 48 hours after surgery.
Read the detailed description
Total hip arthroplasty (THA) is associated with moderate-to-severe postoperative pain, which can impair early mobilization and functional recovery. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block and the erector spinae plane (ESP) block, have been introduced as motor-sparing alternatives to femoral and lumbar plexus blocks. The PENG block targets articular branches of the femoral, obturator, and accessory obturator nerves, offering effective analgesia with minimal motor blockade. Meanwhile, the lumbar ESPB (L-ESPB) and sacral ESPB (S-ESPB) may provide a broader, yet still motor-sparing, analgesic field by targeting both lumbar and sacral nerve roots involved in hip innervation.
To date, no randomized trial has compared PENG with a dual-level ESP block approach (L-ESPB + S-ESPB) in THA patients.
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic
- Being tested
- Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution
- 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 0.5% Injectable SolutionDrug
Also called Spinal Anesthesia
All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.
Ropivacaine 0.2% Injectable SolutionDrug
Ultrasound-guided pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, with sham lumbar and sacral ESPBs.
PENG block: 20 mL of 0.2% ropivacaine. LFCN block: 5 mL of 0.2% ropivacaine. Sham lumbar ESPB: 1-2 mL preservative-free normal saline at lumbar ESPB site. Sham sacral ESPB: 1-2 mL preservative-free normal saline at sacral ESPB site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.
Ropivacaine 0.2% Injectable SolutionDrug
Ultrasound-guided lumbar erector spinae plane block (L-ESPB) and sacral erector spinae plane block (S-ESPB), with sham PENG and LFCN blocks.
Lumbar ESPB: 20 mL of 0.2% ropivacaine at L3 transverse process level. Sacral ESPB: 20 mL of 0.2% ropivacaine at sacral intermediate crest. Sham PENG block: 1-2 mL preservative-free normal saline at PENG site. Sham LFCN block: 1-2 mL preservative-free normal saline at LFCN site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | All participants will receive standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia according to institutional protocol. Receives: Drug: Ropivacaine 0.5% Injectable Solution |
| PENG + LFCN | Active comparator | Participants in this group will receive an ultrasound-guided pericapsular nerve group (PENG) block combined with a lateral femoral cutaneous nerve (LFCN) block using local anesthetic. To preserve blinding, sham procedures will be performed at the lumbar and sacral erector spinae plane block sites (needle insertion and injection of 1-2 mL normal saline). Standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia will be administered as per institutional protocol. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| L-ESPB + S-ESPB | Active comparator | Participants in this group will receive ultrasound-guided lumbar erector spinae plane block (L-ESPB) combined with sacral erector spinae plane block (S-ESPB) using local anesthetic. To preserve blinding, sham procedures will be performed at the pericapsular and lateral femoral cutaneous nerve block sites (needle insertion and injection of 1-2 mL normal saline). Standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia will be provided according to institutional protocol. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
morphine milligram equivalents (MME)
Measured: first 48 hours postoperatively
Secondary outcomes (11)
Pain scores
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 4 hours after surgery
Pain scores
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
Measured: 8 hours after surgery
Pain scores
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
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
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 ambulation
Time to ambulation is defined as the time interval (in hours) from the end of surgery (skin closure) to the patient's first successful attempt at ambulation with or without assistance, as determined by the attending physiotherapist or nursing staff.
Measured: 48 hours after surgery
Quadriceps muscle strength
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Measured: 4 hours after surgery
Quadriceps muscle strength
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Measured: 8 hours after surgery
Quadriceps muscle strength
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Measured: 12 hours after surgery
Quadriceps muscle strength
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Measured: 24 hours after surgery
Quadriceps muscle strength
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
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 posted18 Sep 2025
- Study start15 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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, Study chair, Poznan University of Medical SciencesTomasz Reysenr, M.D., Principal investigator, Poznan Univesity of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180979
- Sponsor's protocol ID
- 03/2025
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Reysner T, Ciftci B, Alver S, Wieczorowska-Tobis K, Reysner M. Comparison of pericapsular nerve group block combined with a lateral femoral cutaneous nerve (LFCN) block versus lumbar and sacral erector spinae plane blocks for analgesia after total hip arthroplasty: study protocol for a randomized, controlled trial with blinded outcome assessment. Pain Manag. 2026 May 18:1-8. doi: 10.1080/17581869.2026.2676100. Online ahead of print.
PubMed 42148589
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block (L-ESPB) Combined With Sacral ESPB (S-ESPB) for Analgesia in Total Hip Arthroplasty (THA): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07180979
- Acronym / sponsor ID
- 03/2025
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 18 Sep 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.
The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery.
The main questions it aims to answer are:
Does the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique? Which method provides better pain relief, preserves muscle strength, and supports earlier mobilization? Researchers will compare the Pericapsular Nerve Group (PENG) block with the combination of Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB + S-ESPB) to see which provides better pain control, fewer side effects, and faster recovery.
Participants will:
Be randomly assigned to receive one of the two types of ultrasound-guided regional anesthesia Undergo standard hip replacement surgery under spinal anesthesia Be monitored for pain scores, opioid use, time to first walking, muscle strength, satisfaction, and side effects over the first 48 hours after surgery.
Detailed description
Total hip arthroplasty (THA) is associated with moderate-to-severe postoperative pain, which can impair early mobilization and functional recovery. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block and the erector spinae plane (ESP) block, have been introduced as motor-sparing alternatives to femoral and lumbar plexus blocks. The PENG block targets articular branches of the femoral, obturator, and accessory obturator nerves, offering effective analgesia with minimal motor blockade. Meanwhile, the lumbar ESPB (L-ESPB) and sacral ESPB (S-ESPB) may provide a broader, yet still motor-sparing, analgesic field by targeting both lumbar and sacral nerve roots involved in hip innervation.
To date, no randomized trial has compared PENG with a dual-level ESP block approach (L-ESPB + S-ESPB) in THA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Ropivacaine 0.5% Injectable SolutionAll participants will receive standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia according to institutional protocol. |
| PENG + LFCN | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionParticipants in this group will receive an ultrasound-guided pericapsular nerve group (PENG) block combined with a lateral femoral cutaneous nerve (LFCN) block using local anesthetic. To preserve blinding, sham procedures will be performed at the lumbar and sacral erector spinae plane block sites (needle insertion and injection of 1-2 mL normal saline). Standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia will be administered as per institutional protocol. |
| L-ESPB + S-ESPB | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionParticipants in this group will receive ultrasound-guided lumbar erector spinae plane block (L-ESPB) combined with sacral erector spinae plane block (S-ESPB) using local anesthetic. To preserve blinding, sham procedures will be performed at the pericapsular and lateral femoral cutaneous nerve block sites (needle insertion and injection of 1-2 mL normal saline). Standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia will be provided according to institutional protocol. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- ASA physical status I-III
- Elective unilateral THA via posterior or lateral approach
- Informed consent provided
Key exclusion criteria (6 listed)
- Allergy to study drugs (ropivacaine, dexamethasone)
- Chronic opioid use (>30 MME/day)
- Coagulopathy or infection at the injection site
- BMI > 40 kg/m²
- Pre-existing motor weakness or neuropathy in the affected limb
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 0.5% Injectable SolutionAlso: Spinal AnesthesiaAll patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty. | Drug | Control group |
| Ropivacaine 0.2% Injectable SolutionUltrasound-guided pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, with sham lumbar and sacral ESPBs. PENG block: 20 mL of 0.2% ropivacaine. LFCN block: 5 mL of 0.2% ropivacaine. Sham lumbar ESPB: 1-2 mL preservative-free normal saline at lumbar ESPB site. Sham sacral ESPB: 1-2 mL preservative-free normal saline at sacral ESPB site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty. | Drug | PENG + LFCN |
| Ropivacaine 0.2% Injectable SolutionUltrasound-guided lumbar erector spinae plane block (L-ESPB) and sacral erector spinae plane block (S-ESPB), with sham PENG and LFCN blocks. Lumbar ESPB: 20 mL of 0.2% ropivacaine at L3 transverse process level. Sacral ESPB: 20 mL of 0.2% ropivacaine at sacral intermediate crest. Sham PENG block: 1-2 mL preservative-free normal saline at PENG site. Sham LFCN block: 1-2 mL preservative-free normal saline at LFCN site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty. | Drug | L-ESPB + S-ESPB |
Primary outcome
Total opioid consumption
Time frame: first 48 hours postoperatively
morphine milligram equivalents (MME)
11 secondary outcomes
Pain scores
Time frame: 4 hours after surgery
Pain scores
Time frame: 8 hours after surgery
Pain scores
Time frame: 12 hours after surgery
Pain scores
Time frame: 24 hours after surgery
Pain scores
Time frame: 48 hours after surgery
Time to ambulation
Time frame: 48 hours after surgery
Quadriceps muscle strength
Time frame: 4 hours after surgery
Quadriceps muscle strength
Time frame: 8 hours after surgery
Quadriceps muscle strength
Time frame: 12 hours after surgery
Quadriceps muscle strength
Time frame: 24 hours after surgery
Quadriceps muscle strength
Time frame: 48 hours after surgery
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 7 May 2026.
- Derived from this study: PubMed 42148589Reysner T, Ciftci B, Alver S, Wieczorowska-Tobis K, Reysner M. Comparison of pericapsular nerve group block combined with a lateral femoral cutaneous nerve (LFCN) block versus lumbar and sacral erector spinae plane blocks for analgesia after total hip arthroplasty: study protocol for a randomized, controlled trial with blinded outcome assessment. Pain Manag. 2026 May 18:1-8. doi: 10.1080/17581869.2026.2676100. Online ahead of print.
- 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 study chair
Poznan University of Medical Sciences
Tomasz Reysenr, M.D. principal investigator
Poznan Univesity 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 Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.2% Injectable Solution in people with Hip Osteoarthritis and Hip Arthropathy, 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: looking for participants now, as of the sponsor's last update on 7 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
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, M.D. Ph.D. (+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?
Total opioid consumption (time frame: first 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180979, which also lists 1 linked publication.
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 7 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.