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NCT Number: NCT06406010

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ropivacaine 5mg/ml 20ml

Drug

administered in a pericapsular nerve group (PENG) block

saline 0.9%

Drug

administered in a pericapsular nerve group (PENG) block

Primary outcomes

  1. 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

Secondary outcomes

  1. Presence of moderate to severe pain

    Time frame: within 3 hours

    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.

  2. Pain during mobilization

    Time frame: within 5 hours

    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

  3. Opioid use 24 hours

    Time frame: 24 hours

    Opioid use from tracheal extubation until 24 hours postoperatively

  4. Pain during mobilization

    Time frame: within 24 hours

    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
  5. First opioid

    Time frame: within 24 hours

    Time to first opioid

  6. Last opioid

    Time frame: within a week

    Time to last opioid

  7. Time to first PONV-medication

    Time frame: within 24 hours

    Time to first PONV-medication

  8. Opioid use at PACU

    Time frame: within 24 hours

    Opioid use at PACU

  9. Sleep quality/pain during sleep.

    Time frame: within 24 hours

    During the first postoperative night the patients answer yes/no to whether they awoke from their sleep because of pain.

  10. Length of stay at hospital

    Time frame: within a week

    Length of stay at hospital

  11. Length of time to fulfilling PACU discharge criteria

    Time frame: within 24 hours

    Length of time to fulfilling PACU discharge criteria

  12. Defecation

    Time frame: within 24 hours

    Time to first defecation

Study contacts

Contact information is provided by the study sponsor or research team.

Matias Vested

CONTACT

[email protected]

+4535455747

Sponsors and collaborators

Lead sponsor

Matias Vested

Other

Registry information

Official study title

A Blinded Randomized Study Investigating the Effect of Pericapsular Nerve Group (PENG) Block on Postoperative Pain After Peri-acetabular Osteotomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 9, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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