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Recruiting NCT06406010

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

Phase IV Interventional Anesthesia, Local

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropivacaine 5mg/ml 20ml, Saline 0.9%.
Who it may be relevant to
Registry conditions: Anesthesia, Local. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug Ropivacaine 5mg/ml 20ml
    administered in a pericapsular nerve group (PENG) block
  • Drug Saline 0.9%
    administered in a pericapsular nerve group (PENG) block

Primary outcome measures

  • Pain during first 24 hours postoperatively [Time frame: 24 hours postoperatively]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT06406010 · PENG for PAO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗