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临床试验/NCT01555216
NCT01555216撤回不适用

A Randomized Comparison of a Continuous Posterior Tibial Nerve Block and Single Injection Posterior Tibial Nerve Block in Patients Undergoing Forefoot Surgery

Northwestern University1 个研究点 分布在 1 个国家开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Quality of recovery

研究概览

简要总结

Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of postoperative pain control included oral narcotics, single injection regional techniques and more recently continuous nerve catheters. Recent studies have demonstrated a benefit with continuous popliteal catheters when compared to single injection techniques in regards to postoperative pain control and patient satisfaction for foot surgeries.

Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and does not involve the peroneal nerve. The purpose of this study is to compare the continuous posterior tibial nerve catheter with a single injection posterior tibial nerve block when used as part of a surgical ankle block for forefoot surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy).

排除标准

  • Patient refusal to be included
  • Presence of language barrier that prohibits proper communication with patient
  • Under age of 18,
  • Pregnancy
  • History of allergy to local anesthetics or opioids
  • Presence of a progressive neurological deficit
  • Chronic opioid or drug abuse
  • Active infection in leg
  • Unstable cardiovascular, renal or hepatic disease,
  • Unwillingness to comply with follow up.

研究组 & 干预措施

Posterior tibial nerve catheter

Active Comparator

5 ml bolus of 0.5% ropivacaine. The catheter will then be connected to a portable pump delivering 3 ml/h of 0.2% ropivacaine with a 2ml bolus every two hours.

干预措施: Posterior tibial nerve catheter (Drug)

Single injection PTNB

Active Comparator

Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine

干预措施: Single injection posterior tibial nerve block (Drug)

结局指标

主要结局

Quality of recovery

时间窗: Up to five days

Quality of recovery

次要结局

  • patient satisfaction(Up to 1 week)
  • Pain control (pain score)(Up to 1 week)
  • Opioid consumption(Up to 1 week)

研究者

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

Antoun Nader

Associate Professor in Anesthesiology and Orthopaedic Surgery

Northwestern University

研究点 (1)

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