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临床试验/NCT05261009
NCT05261009已完成4 期

PENG Block Versus LP Block for Postoperative Analgesia After Anterior Total Hip

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2022年6月13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
入组人数
154
试验地点
1
主要终点
Numeric Rating Scale (NRS) Pain Score

研究概览

简要总结

The purpose of this randomized, double blinded, prospective study is to compare the postoperative analgesia provided by the PENG block to that provided by the LPB for patients undergoing primary anterior approach THA.

详细描述

Regional anesthesia procedures represent a common modality for postoperative analgesia after total hip arthroplasty surgeries (THA). The standard practice many years has been the Lumbar Plexus block (LPB), which anesthetizes the L1-L5 lumbar nerve roots1. While the LPB offers analgesia from the associated sensory block, it also blocks motor fibers, leading to lower extremity weakness that could potentially delay the patient's ability to participate in early physical therapy and may thereby delay discharge. In the past several years, newer regional anesthesia block approaches have been described and investigated in an attempt to provide patients with postoperative analgesia while avoiding associated muscle weakness, facilitating earlier physical therapy participation and discharge. One such nerve block is the peri-capsular nerve group (PENG) block, which anesthetizes the articular branches of the femoral, obturator, and accessory obturator nerves providing sensory innervation to the hip joint capsule without consistently causing lower extremity weakness2. Some institutions are utilizing the PENG block to provide postoperative analgesia and facilitate early mobilization. There are currently no prospective studies that directly compare the efficacy of LPB to PENG block for providing postoperative analgesia after THA.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective primary total hip arthroplasty surgery anterior approach
  • provided informed consent
  • no contraindications to medications used in providing the analgesic blocks

排除标准

  • contraindications to regional anesthesia, such as an allergy to amide local anesthetics
  • pre-existing coagulopathy or thrombocytopenia <100,000
  • refusal of analgesic block for pain management
  • presence of an progressive lower extremity neurological deficit
  • localized or systemic infection
  • chronic use of high dose opioid analgesics (defined as daily use greater than 60 mg oxycodone equivalents)
  • refusal of consent

研究组 & 干预措施

Peri-capsular Nerve Group (PENG)

Experimental

Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.

干预措施: Peri-capsular Nerve Group (PENG) (Drug)

Lumbar Plexus Block (LPB)

Active Comparator

Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.

干预措施: Lumbar Plexus Block (LPB) (Other)

结局指标

主要结局

Numeric Rating Scale (NRS) Pain Score

时间窗: hour 6

a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at six hours following block placement. Equivalency will be defined as a difference of less than one point in either direction on the eleven-point NRS pain scale. Score ranges from 0-10 with a higher score denoting more pain.

次要结局

  • NRS Pain Score(hour 24)
  • Time in Minutes Until Opioid Administration(hour 24)
  • Motor Strength(hour 6)
  • Distance Ambulated(hour 24)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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