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临床试验/NCT07180979
NCT07180979招募中4 期

Comparison of Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block (L-ESPB) Combined With Sacral ESPB (S-ESPB) for Analgesia in Total Hip Arthroplasty (THA): A Randomized Clinical Trial

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年9月15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
1
主要终点
Total opioid consumption

研究概览

简要总结

The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery.

The main questions it aims to answer are:

Does the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique? Which method provides better pain relief, preserves muscle strength, and supports earlier mobilization? Researchers will compare the Pericapsular Nerve Group (PENG) block with the combination of Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB + S-ESPB) to see which provides better pain control, fewer side effects, and faster recovery.

Participants will:

Be randomly assigned to receive one of the two types of ultrasound-guided regional anesthesia Undergo standard hip replacement surgery under spinal anesthesia Be monitored for pain scores, opioid use, time to first walking, muscle strength, satisfaction, and side effects over the first 48 hours after surgery.

详细描述

Total hip arthroplasty (THA) is associated with moderate-to-severe postoperative pain, which can impair early mobilization and functional recovery. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block and the erector spinae plane (ESP) block, have been introduced as motor-sparing alternatives to femoral and lumbar plexus blocks. The PENG block targets articular branches of the femoral, obturator, and accessory obturator nerves, offering effective analgesia with minimal motor blockade. Meanwhile, the lumbar ESPB (L-ESPB) and sacral ESPB (S-ESPB) may provide a broader, yet still motor-sparing, analgesic field by targeting both lumbar and sacral nerve roots involved in hip innervation.

To date, no randomized trial has compared PENG with a dual-level ESP block approach (L-ESPB + S-ESPB) in THA patients.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 65 years
  • ASA physical status I-III
  • Elective unilateral THA via posterior or lateral approach
  • Informed consent provided

排除标准

  • Allergy to study drugs (ropivacaine, dexamethasone)
  • Chronic opioid use (>30 MME/day)
  • Coagulopathy or infection at the injection site
  • BMI > 40 kg/m²
  • Pre-existing motor weakness or neuropathy in the affected limb
  • Cognitive impairment precluding informed consent

研究组 & 干预措施

L-ESPB + S-ESPB

Active Comparator

Participants in this group will receive ultrasound-guided lumbar erector spinae plane block (L-ESPB) combined with sacral erector spinae plane block (S-ESPB) using local anesthetic. To preserve blinding, sham procedures will be performed at the pericapsular and lateral femoral cutaneous nerve block sites (needle insertion and injection of 1-2 mL normal saline). Standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia will be provided according to institutional protocol.

干预措施: Ropivacaine 0.2% Injectable Solution (Drug)

Control group

Placebo Comparator

All participants will receive standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia according to institutional protocol.

干预措施: Ropivacaine 0.5% Injectable Solution (Drug)

PENG + LFCN

Active Comparator

Participants in this group will receive an ultrasound-guided pericapsular nerve group (PENG) block combined with a lateral femoral cutaneous nerve (LFCN) block using local anesthetic. To preserve blinding, sham procedures will be performed at the lumbar and sacral erector spinae plane block sites (needle insertion and injection of 1-2 mL normal saline). Standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia will be administered as per institutional protocol.

干预措施: Ropivacaine 0.2% Injectable Solution (Drug)

结局指标

主要结局

Total opioid consumption

时间窗: first 48 hours postoperatively

morphine milligram equivalents (MME)

Total opioid consumption

时间窗: first 48 hours postoperatively

morphine milligram equivalents (MME)

次要结局

  • Pain scores(48 hours after surgery)
  • Time to ambulation(48 hours after surgery)
  • Quadriceps muscle strength(48 hours after surgery)
  • Pain scores(48 hours after surgery)
  • Time to ambulation(48 hours after surgery)
  • Quadriceps muscle strength(48 hours after surgery)
  • Pain scores(4 hours after surgery)
  • Pain scores(8 hours after surgery)
  • Pain scores(12 hours after surgery)
  • Pain scores(24 hours after surgery)
  • Quadriceps muscle strength(4 hours after surgery)
  • Quadriceps muscle strength(8 hours after surgery)
  • Quadriceps muscle strength(12 hours after surgery)
  • Quadriceps muscle strength(24 hours after surgery)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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