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临床试验/NCT05391464
NCT05391464招募中不适用

Preoperative Versus Postoperative Peripheral Nerve Block for Pain Control After Ankle and Wrist Fracture Surgery

MaineGeneral Health2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年5月16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
160
试验地点
2
主要终点
Pain 24 hours

研究概览

简要总结

Surgical treatment for patients with a fracture of the ankle or distal radius is commonly offered on an outpatient basis. Patients are routinely discharged from hospital within 4 hours of their procedure. The surgery is commonly performed under peripheral nerve block with sedation, or under general anesthesia with postoperative peripheral nerve block, (if required for analgesic purposes). It is unclear which of these two strategies offers patients superior pain relief in the first few days following surgery. This trial aims to compare the pain intensity and analgesic medication consumption between patients in these two groups.

详细描述

Background:

Open reduction and internal fixation (ORIF) surgery for a fracture of the ankle or distal radius is a commonly performed outpatient orthopedic procedure. Surgery is routinely performed under a preoperative peripheral nerve block (PNB) with sedation, or under general anesthesia (GA) with supplemental postoperative PNB for analgesic purposes. The method chosen is often influenced by the opinion and experience of the anesthetic team. There is no consensus as to whether PNB should be utilized preoperatively, or reserved for 'as needed' cases postoperatively.

The use of PNB in fracture surgery has been recommended in order to reduce perioperative opioid analgesic requirements and improve postoperative pain, particularly in the context of the ongoing opioid epidemic. For patients undergoing ORIF for ankle or distal radius fractures, successfully administered PNB can provide excellent pain relief in the first 8 to 12 hours post-surgery. However, a concern with PNB is rebound pain, the presence of delayed acute postoperative pain at 12 to 24 hours, affecting up to 50% of patients.

With a majority of extremity fracture surgeries performed on an outpatient basis, patients who experience rebound pain will do so after leaving hospital. PNB might therefore not provide satisfactory analgesia when patients are in most need of it. Instead, GA might offer a more desirable postoperative pain profile with patients experiencing peak pain intensity shortly after surgery, followed by steady improvement prior to discharge. In the context of rationalizing the potency of discharge prescription opioids, having less pain post-discharge is preferable.

Rather than universally adopting preoperative PNB for those undergoing ankle or distal radius ORIF, a more targeted approach might improve patients' postoperative pain experience. Performing surgery under GA, and offering postoperative PNB 'as needed' to those whose pain is poorly controlled, has the advantage of avoiding the risks of PNB administration (and potential post-discharge rebound pain) in patients whose pain is manageable after GA. Furthermore, while preoperative PNB is associated with decreased intraoperative opioid requirement, there is no consensus that offering PNB postoperatively is clinically inferior in terms of the analgesia provided, or the subsequent risk of rebound pain.

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
None

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

  • Within 2 weeks of injury
  • Isolated fracture requiring surgery
  • Outpatient

排除标准

  • Multiple fractures
  • Inpatients
  • Cognitive impairment
  • Unable to comply with follow-up
  • No means of telephone contact
  • Contraindication to peripheral nerve block

结局指标

主要结局

Pain 24 hours

时间窗: 24 hours postop

Patient-rated measure, 0-10 visual analogue scale

次要结局

  • Pain 12 hours(12 hours postop)
  • Nausea and Vomiting 24 hours(24 hours postop)
  • Pain Functional Activity Scale 24 hours(24 hours postop)
  • Pain Functional Activity Scale 48 hours(48 hours postop)
  • Pain 48 hours(48 hours postop)

研究者

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

Stuart A Aitken

Principal Investigator

MaineGeneral Health

研究点 (2)

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