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临床试验/NCT06406010
NCT06406010招募中4 期

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

Matias Vested2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年8月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
90
试验地点
2
主要终点
Pain during first 24 hours postoperatively

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Ropivacaine group

Experimental

Ropivacaine 5 mg/ml 20ml

干预措施: Ropivacaine 5mg/ml 20ml (Drug)

Saline group

Placebo Comparator

NaCl 0.9%

干预措施: Saline 0.9% (Drug)

结局指标

主要结局

Pain during first 24 hours postoperatively

时间窗: 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

次要结局

  • Sleep quality/pain during sleep.(within 24 hours)
  • Presence of moderate to severe pain(within 3 hours)
  • First opioid(within 24 hours)
  • Opioid use at PACU(within 24 hours)
  • Length of stay at hospital(within a week)
  • Length of time to fulfilling PACU discharge criteria(within 24 hours)
  • Pain during mobilization(within 24 hours)
  • Opioid use 24 hours(24 hours)
  • Last opioid(within a week)
  • Time to first PONV-medication(within 24 hours)
  • Defecation(within 24 hours)
  • Pain during mobilization(within 5 hours)

研究者

发起方
Matias Vested
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matias Vested

MD PhD

Rigshospitalet, Denmark

研究点 (2)

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