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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Rigshospitalet

    Copenhagen, 2100

    Matias Vested, +4535455747, matias.vested@regionh.dk

    Recruiting

Other trials in Denmark

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.

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 groups in NCT06406010
Study groupRoleWhat they receive
Ropivacaine groupExperimentalRopivacaine 5 mg/ml 20ml
Receives: Drug: Ropivacaine 5mg/ml 20ml
Saline groupPlacebo comparatorNaCl 0.9%
Receives: Drug: Saline 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. Opioid use 24 hours

    Opioid use from tracheal extubation until 24 hours postoperatively

    Measured: 24 hours

  4. 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

  5. First opioid

    Time to first opioid

    Measured: within 24 hours

  6. Last opioid

    Time to last opioid

    Measured: within a week

  7. Time to first PONV-medication

    Time to first PONV-medication

    Measured: within 24 hours

  8. Opioid use at PACU

    Opioid use at PACU

    Measured: within 24 hours

  9. 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

  10. Length of stay at hospital

    Length of stay at hospital

    Measured: within a week

  11. Length of time to fulfilling PACU discharge criteria

    Length of time to fulfilling PACU discharge criteria

    Measured: within 24 hours

  12. 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.

  1. First posted9 May 2024
  2. Study start19 Aug 2024
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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)
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

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.

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