Anesthesia, LocalPhase 4NCT06406010
Investigating the Effect of Pericapsular Nerve Group (PENG) Block on Postoperative Pain After Peri-acetabular Osteotomy
A Phase 4 study testing Ropivacaine 5mg/ml 20ml and Saline 0.9% in people with Anesthesia, Local, run by Matias Vested at 1 site in Denmark.
Trial summary
The aim of this study is to determine the effect of PENG blockade on postoperative pain after either ropivacaine 5 mg/mL or saline (placebo) in patients undergoing PAO. The hypothesis of this study is that PENG block with ropivacaine reduces postoperative pain compared to placebo (saline). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Ropivacaine 5mg/ml 20ml and Saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Aug 2024to 1 Mar 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old
- Informed consent
- Scheduled for periacetabular osteotomy under general anesthesia with intubation
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Can read and understand Danish
Who cannot join
- Known allergy to ropivacaine
- Daily use of opioids, gabapentin or tricyclic antidepressant (regardless of dose) within the last four weeks prior to surgery
- Contraindications to Celocoxib, NSAIDs or paracetamol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Matias Vested, +4535455747, matias.vested@regionh.dk
About this study
Official title: A Blinded Randomized Study Investigating the Effect of Pericapsular Nerve Group (PENG) Block on Postoperative Pain After Peri-acetabular Osteotomy
The aim of this study is to determine the effect of PENG blockade on postoperative pain after either ropivacaine 5 mg/mL or saline (placebo) in patients undergoing PAO. The hypothesis of this study is that PENG block with ropivacaine reduces postoperative pain compared to placebo (saline).
Read the detailed description
Peri-acetabular osteotomy (PAO) is the joint-preserving treatment of choice in young adults with symptomatic hip dysplasia. However, moderate to severe pain occurs frequently in the postoperative period. Pain after PAO comes primarily from the anterior hip capsule which is innervated by the terminal nerves of the lumbar plexus comprising branches from the femoral, obturator and accessory obturator nerves. The articular branches from the femoral nerve reach the plane between the iliopsoas muscle and the iliofemoral ligament (iliopsoas plane) and innervate the anterior and lateral aspects of the hip capsule. The articular branches innervate the anterior and medial aspects of the hip capsule and the accessory obturator nerve contributes to the innervation of the hip in 10%-30% of the patients, and supplies the inferomedial aspect of the hip capsule. The PAO procedure, involving three osteotomies in otherwise healthy individuals, is likely to produce a substantial surgical stress response, which potentially could be alleviated by multimodal analgesia including the pericapsular nerve group (PENG) block.
The PENG block is a novel regional anaesthesia technique that has been proposed as an effective motor-sparing block for total hip arthroplasty. The PENG block targets the articular branches providing innervation to the anterior capsule of the hip joint, including the femoral, obturator and accessory obturator nerves. Its potential analgesic and motor-sparing effect is desirable for early ambulation, better physical therapy, and earlier discharge.
Conventional opioid-sparing regional anaesthetic techniques such as lumbar plexus and femoral nerve blocks are effective but carry a risk of undesirable lower limb muscle weakness. Alternatively, the fascia iliaca block does not consistently provide adequate pain relief for hip surgeries.
The anterior capsule of the hip has a high density of nociceptors and mechanoreceptors and appears to be the primary source of pain after hip surgery. The PENG block targets the articular branches providing innervation to the anterior capsule of the hip joint, including the femoral, obturator and accessory obturator nerves.
A recent study reported improved quality of recovery and reduced opioid requirements for patients undergoing primary THA whereas other studies have reported conflicting results regarding the analgesic efficacy for THA. However, the effect of PENG on PAO has not been investigated.
Thus, in order to investigate if PENG block is superior to placebo in decreasing immediate pain and other complications after PAO, the investigators aim to conduct a randomised, double-blinded trial of ropivacaine 5 mg/ml vs. placebo. The investigators hypothesize that patients given ropivacaine 5 mg/ml will have less pain in the first 24 postoperative hours compared with patients given placebo.
- Conditions
- Anesthesia, Local
- Being tested
- Ropivacaine 5mg/ml 20ml, Saline 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 5mg/ml 20mlDrug
administered in a pericapsular nerve group (PENG) block
Saline 0.9%Drug
administered in a pericapsular nerve group (PENG) block
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine group | Experimental | Ropivacaine 5 mg/ml 20ml Receives: Drug: Ropivacaine 5mg/ml 20ml |
| Saline group | Placebo comparator | NaCl 0.9% Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during first 24 hours postoperatively
Area under curve (AUC) of pain reported on a numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable) during the first 24 hours postoperatively
Measured: 24 hours postoperatively
Secondary outcomes (12)
Presence of moderate to severe pain
The number of patients reporting moderate to severe pain at rest [>3 out of 10 on a numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable)] at any point in the immediate postoperative phase (from arrival at the PACU until transfer to the ward). NRS will be assessed upon arrival at the PACU and each 30 minutes.
Measured: within 3 hours
Pain during mobilization
Pain during during mobilization (from laying down in bed till standing on the floor) assessed on numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable) at 5 hours after extubation
Measured: within 5 hours
Opioid use 24 hours
Opioid use from tracheal extubation until 24 hours postoperatively
Measured: 24 hours
Pain during mobilization
Pain during during mobilization (from laying down in bed till standing on the floor) assessed on numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable) at:
- postoperative day one between 8 and 10 pm
- 24 hours after extubation
Measured: within 24 hours
First opioid
Time to first opioid
Measured: within 24 hours
Last opioid
Time to last opioid
Measured: within a week
Time to first PONV-medication
Time to first PONV-medication
Measured: within 24 hours
Opioid use at PACU
Opioid use at PACU
Measured: within 24 hours
Sleep quality/pain during sleep.
During the first postoperative night the patients answer yes/no to whether they awoke from their sleep because of pain.
Measured: within 24 hours
Length of stay at hospital
Length of stay at hospital
Measured: within a week
Length of time to fulfilling PACU discharge criteria
Length of time to fulfilling PACU discharge criteria
Measured: within 24 hours
Defecation
Time to first defecation
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start19 Aug 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Model description
- Randomized study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matias Vested
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matias Vested, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Matias Vested, Md, PhD, Study chair, Rigshospitalet University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406010
- Sponsor's protocol ID
- PENG for PAO
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded Randomized Study Investigating the Effect of Pericapsular Nerve Group (PENG) Block on Postoperative Pain After Peri-acetabular Osteotomy
- ClinicalTrials.gov ID
- NCT06406010
- Acronym / sponsor ID
- PENG for PAO
- Conditions
- Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Matias VestedUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 May 2024 (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 aim of this study is to determine the effect of PENG blockade on postoperative pain after either ropivacaine 5 mg/mL or saline (placebo) in patients undergoing PAO. The hypothesis of this study is that PENG block with ropivacaine reduces postoperative pain compared to placebo (saline).
Detailed description
Peri-acetabular osteotomy (PAO) is the joint-preserving treatment of choice in young adults with symptomatic hip dysplasia. However, moderate to severe pain occurs frequently in the postoperative period. Pain after PAO comes primarily from the anterior hip capsule which is innervated by the terminal nerves of the lumbar plexus comprising branches from the femoral, obturator and accessory obturator nerves. The articular branches from the femoral nerve reach the plane between the iliopsoas muscle and the iliofemoral ligament (iliopsoas plane) and innervate the anterior and lateral aspects of the hip capsule. The articular branches innervate the anterior and medial aspects of the hip capsule and the accessory obturator nerve contributes to the innervation of the hip in 10%-30% of the patients, and supplies the inferomedial aspect of the hip capsule. The PAO procedure, involving three osteotomies in otherwise healthy individuals, is likely to produce a substantial surgical stress response, which potentially could be alleviated by multimodal analgesia including the pericapsular nerve group (PENG) block.
The PENG block is a novel regional anaesthesia technique that has been proposed as an effective motor-sparing block for total hip arthroplasty. The PENG block targets the articular branches providing innervation to the anterior capsule of the hip joint, including the femoral, obturator and accessory obturator nerves. Its potential analgesic and motor-sparing effect is desirable for early ambulation, better physical therapy, and earlier discharge.
Conventional opioid-sparing regional anaesthetic techniques such as lumbar plexus and femoral nerve blocks are effective but carry a risk of undesirable lower limb muscle weakness. Alternatively, the fascia iliaca block does not consistently provide adequate pain relief for hip surgeries.
The anterior capsule of the hip has a high density of nociceptors and mechanoreceptors and appears to be the primary source of pain after hip surgery. The PENG block targets the articular branches providing innervation to the anterior capsule of the hip joint, including the femoral, obturator and accessory obturator nerves.
A recent study reported improved quality of recovery and reduced opioid requirements for patients undergoing primary THA whereas other studies have reported conflicting results regarding the analgesic efficacy for THA. However, the effect of PENG on PAO has not been investigated.
Thus, in order to investigate if PENG block is superior to placebo in decreasing immediate pain and other complications after PAO, the investigators aim to conduct a randomised, double-blinded trial of ropivacaine 5 mg/ml vs. placebo. The investigators hypothesize that patients given ropivacaine 5 mg/ml will have less pain in the first 24 postoperative hours compared with patients given placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized study
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine group | Experimental | Drug: Ropivacaine 5mg/ml 20mlRopivacaine 5 mg/ml 20ml |
| Saline group | Placebo comparator | Drug: Saline 0.9%NaCl 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years old
- Informed consent
- Scheduled for periacetabular osteotomy under general anesthesia with intubation
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Can read and understand Danish
Key exclusion criteria (3 listed)
- Known allergy to ropivacaine
- Daily use of opioids, gabapentin or tricyclic antidepressant (regardless of dose) within the last four weeks prior to surgery
- Contraindications to Celocoxib, NSAIDs or paracetamol
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 5mg/ml 20mladministered in a pericapsular nerve group (PENG) block | Drug | Ropivacaine group |
| Saline 0.9%administered in a pericapsular nerve group (PENG) block | Drug | Saline group |
Primary outcome
Pain during first 24 hours postoperatively
Time frame: 24 hours postoperatively
Area under curve (AUC) of pain reported on a numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable) during the first 24 hours postoperatively
12 secondary outcomes
Presence of moderate to severe pain
Time frame: within 3 hours
Pain during mobilization
Time frame: within 5 hours
Opioid use 24 hours
Time frame: 24 hours
Pain during mobilization
Time frame: within 24 hours
First opioid
Time frame: within 24 hours
Last opioid
Time frame: within a week
Time to first PONV-medication
Time frame: within 24 hours
Opioid use at PACU
Time frame: within 24 hours
Sleep quality/pain during sleep.
Time frame: within 24 hours
Length of stay at hospital
Time frame: within a week
Length of time to fulfilling PACU discharge criteria
Time frame: within 24 hours
Defecation
Time frame: within 24 hours
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Matias Vested, Md, PhD study chair
Rigshospitalet University of Copenhagen
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 5mg/ml 20ml and Saline 0.9% in people with Anesthesia, Local, run by Matias Vested at 1 site in Denmark.
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 5 inclusion and 3 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 15 Sep 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 Denmark. 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 Matias Vested (+4535455747, matias.vested@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during first 24 hours postoperatively (time frame: 24 hours postoperatively). 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 15 Sep 2026.