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临床试验/NCT07023120
NCT07023120已完成4 期

Optimizing PENG Block in Hip Arthroplasty: Influence of Ropivacaine Volume and Dexamethasone on Analgesic Efficacy

Poznan University of Medical Sciences0 个研究点目标入组 120 人开始时间: 2025年6月25日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
主要终点
Time to first rescue opioid

研究概览

简要总结

This randomized controlled trial investigates the impact of local anesthetic volume and perineural dexamethasone on the analgesic and anti-inflammatory effectiveness of the pericapsular nerve group (PENG) block in patients undergoing total hip arthroplasty (THA). Patients were randomized to receive one of four PENG block variants differing in ropivacaine volume (10 mL or 20 mL of 0.2%) and the addition of 4 mg of perineural dexamethasone. The study evaluates postoperative pain, opioid requirements, systemic inflammatory markers, and quadriceps motor preservation.

详细描述

The pericapsular nerve group (PENG) block has become a widely used motor-sparing component of multimodal analgesia for total hip arthroplasty (THA). However, its optimal formulation-particularly the volume of local anesthetic and the role of adjuvants-remains undetermined. This prospective, double-blind, randomized controlled trial evaluates the influence of ropivacaine volume (10 mL vs. 20 mL of 0.2%) and the addition of perineural dexamethasone (4 mg) on analgesic efficacy, opioid consumption, systemic inflammation, and quadriceps strength preservation.

A total of 120 adult patients undergoing unilateral THA under spinal anesthesia were randomized to one of four PENG block groups:

Group 1: 20 mL of 0.2% ropivacaine (standard-volume PENG) Group 2: 20 mL of 0.2% ropivacaine + 4 mg perineural dexamethasone Group 3: 10 mL of 0.2% ropivacaine (low-volume PENG) Group 4: 10 mL of 0.2% ropivacaine + 4 mg perineural dexamethasone The primary outcome was the time to first rescue opioid analgesia. Secondary outcomes included total 48-hour opioid consumption (expressed in oral morphine equivalents), numeric rating scale (NRS) pain scores, quadriceps muscle strength, neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR) at 12, 24, and 48 hours postoperatively.

Results demonstrated that the addition of dexamethasone, regardless of volume, significantly prolonged the duration of analgesia and reduced opioid consumption compared to non-adjuvanted PENG blocks. The low-volume + dexamethasone group achieved comparable analgesia to high-volume protocols with better inflammatory profiles. Quadriceps strength was preserved in all groups. These findings support the use of perineural dexamethasone as an effective enhancer of PENG block analgesia while enabling lower local anesthetic volume, potentially improving safety and recovery outcomes 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
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥18 years scheduled for primary unilateral total hip arthroplasty (THA).
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Ability to provide written informed consent.
  • Spinal anesthesia planned as the primary anesthetic technique.
  • Body mass index (BMI) between 18 and 35 kg/m².
  • Fluent in the local language and able to understand the NRS pain scoring system.

排除标准

  • Known allergy or hypersensitivity to ropivacaine, dexamethasone, or other amide local anesthetics.
  • Pre-existing neurological deficits or neuropathies affecting lower limb motor or sensory function.
  • Chronic opioid use (daily use >30 mg oral morphine equivalents for >1 month prior to surgery).
  • History of coagulopathy, current anticoagulant therapy not eligible for regional anesthesia.
  • Uncontrolled diabetes mellitus (HbA1c > 9%) or active systemic infection.
  • Pregnancy or breastfeeding.
  • Previous surgery or implantation on the ipsilateral hip.
  • Inability to cooperate with postoperative assessments or participate in follow-up.

研究组 & 干预措施

PENG 20 mL

Active Comparator

Ultrasound-guided PENG block - 20ml 0,2% ropivacaine

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

PENG 20 mL + DEX

Active Comparator

Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone

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

PENG 20 mL + DEX

Active Comparator

Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone

干预措施: Dexamethasone 4mg (Drug)

PENG 10 mL

Active Comparator

Ultrasound-guided PENG block - 10ml 0,2% ropivacaine

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

PENG 10 mL + DEX

Active Comparator

Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone

干预措施: Dexamethasone 4mg (Drug)

PENG 10 mL + DEX

Active Comparator

Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone

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

结局指标

主要结局

Time to first rescue opioid

时间窗: 24 hours after surgery

Time after surgery when the patient needs opiate for the first time

次要结局

  • Numerical Rating Scale [range 0:10](4 hours after surgery)
  • blood glucose(48 hours after surgery)
  • Total 48h opioid consumption(48 hours after surgery)
  • Numerical Rating Scale [range 0:10](48 hours after surgery)
  • NLR(48 hours after surgery)
  • PLR(48 hours after surgery)
  • Quadriceps strength(48 hours after surgery)
  • Nerve damage(48 hours after surgery)
  • Numerical Rating Scale [range 0:10](8 hours after surgery)
  • Numerical Rating Scale [range 0:10](12 hours after surgery)
  • Numerical Rating Scale [range 0:10](24 hours after surgery)
  • NLR(12 hours after surgery)
  • NLR(24 hours after surgery)
  • PLR(12 hours after surgery)
  • PLR(24 hours after surgery)
  • Quadriceps strength(4 hours after surgery)
  • Quadriceps strength(8 hours after surgery)
  • Quadriceps strength(12 hours after surgery)
  • Quadriceps strength(24 hours after surgery)
  • blood glucose(12 hours after surgery)
  • blood glucose(24 hours after surgery)
  • Nerve damage(12 hours after surgery)
  • Nerve damage(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

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