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临床试验/NCT05898581
NCT05898581招募中不适用

Ultrasound-guided Pericapsular Nerve Group (PENG) Block vs. Intraoperative Local Anesthetic Infiltration (ILAI) for Total Hip Arthroplasty (THA): a Single Center, Non-inferiority Randomized Control Trial Pilot Study.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
PENG block impact on post-operative pain scores

研究概览

简要总结

Currently, the analgesic standard of care for patients undergoing total hip arthroplasty (THA) at our centre is intraoperative infiltration with a solution of local anesthetic, morphine (opioid), and ketorolac (nonsteroidal anti-inflammatory drug - NSAID). If a patient has a contraindication for the use of an opioid or NSAIDs, this infiltration is performed with a plain local anesthetic. No blocks (numbing of certain nerves to prevent pain from occurring in that area) are performed for postoperative pain in these patients. The pericapsular nerve group (PENG) block is a recently described technique with limited data in the literature that has assessed the benefits of using this nerve block for THA procedures. The purpose of this study is to investigate if the ultrasound-guided PENG block can provide non-inferior postoperative analgesia compared to local intraoperative anesthetic infiltration (ILAI) with an associated cost benefit for patients undergoing THA.

详细描述

Traditionally, the most common ultrasound-guided nerve blocks utilized for hip analgesia during THA are the Femoral Nerve Block and the Fascia Iliaca Block. Despite the analgesia component of both techniques, they can cause quadriceps weakness1-2, which is an unwanted side effect for this patient population as it interferes with surgical recovery, physical therapy, and increases the risk of fall. For these reasons, these types of blocks are not performed for patients undergoing THA at our center (London Health Science Centre).

In 2018, a cadaveric study performed by Short et al. demonstrated that the hip capsule is innervated by sensory branches of the Femoral Nerve and Accessory Obturator Nerves.3 An ultrasound-guided technique for the blockade of the articular branches of the hip was first described by Giron-Arango et al.4 The major benefit of using this approach is the possible motor-sparing effect, capable of maintaining the quadriceps muscle force as the technique aims only at sensory articular branches.

The current standard care for postoperative analgesia for THA is intraoperative infiltration with a solution containing ropivacaine 0.25% (local anesthetic), morphine (opioid), and ketorolac (NSAID). Patients with any contra-indication for the administration of opioids, or nonsteroidal anti-inflammatories receive intraoperative infiltration with plain local anesthetic.

The efficacy of ILAI for THA remains inconclusive. While some studies validated the benefit of this technique5-9, others were not able to confirm improvements in pain control.10-15 As it is a simple technique based on the injection of analgesic solution in the tissue surrounding the surgical field, it has become a popular intervention.

Similarly, the analgesic efficacy of the PENG block for THA remains unclear. As the PENG block involves sensory articular nerves of the anterior hip capsule, the benefit for the patients lies in the possibility of having a good analgesic response along with no motor leg weakness. This will improve patient care during the postoperative period with early mobilization and adequate pain control. There is limited information in the literature available regarding the use of the PENG block as part of the postoperative analgesia plan for THA. Thus, we have identified a need to conduct a trial that aims to investigate if the ultrasound-guided PENG block can provide non-inferior postoperative analgesia compared to local intraoperative anesthetic infiltration (ILAI).

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Adult patient (>18 years old)
  • Undergoing THA with a direct lateral surgical approach (transgluteal approach)
  • Ability to provide verbal/written consent to participate in this trial

排除标准

  • Patient with any contraindication for spinal anesthesia
  • Patient with any contraindication for regional analgesia
  • Patient undergoing THA with a direct anterior surgical approach
  • Patients undergoing THA for hip revision
  • Patients undergoing THA under One Day Stay (ODS) admission
  • Patients that received opioids intrathecally
  • Patients having residual motor block six hours after the completion of the spinal anesthesia.
  • Patients with a history of regular opioid intake for more than three months
  • Patients incapable of performing knee extension of the same operative side
  • Pregnant patients

结局指标

主要结局

PENG block impact on post-operative pain scores

时间窗: 8-24 hours following completion of spinal anesthesia

Patient pain scores will be evaluated at 8 hours and 24 hours following completion of spinal anesthesia to determine the impact of the PENG block on post-operative pain. Pain scores will be assessed using a Likert scale rating (0-10, 0 = no pain, 10 = sever, disabling pain).

次要结局

  • Time spent in post-anesthesia care unit (PACU) following surgery(Up to 24 hours following completion of spinal anesthesia.)
  • Patient opioid consumption 24 hours period after spinal anesthesia procedure.(24 hours following following completion of spinal anesthesia.)
  • PENG block impact on quadriceps muscle strength post-operatively(8-24 hours following completion of spinal anesthesia)
  • Time spent in post-anesthesia care unit (PACU) following surgery(Up to 24 hours following completion of spinal anesthesia.)
  • Patient opioid consumption 24 hours period after spinal anesthesia procedure.(24 hours following following completion of spinal anesthesia.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shalini Dhir, MD

Anesthesiologist, Associate Professor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (1)

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