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临床试验/NCT04872322
NCT04872322Unknown3 期

Randomized Study of the Effect of Initial Ropivacaine Dosage During Continuous Popliteal Nerve Blocks on Rebound Pain in Foot and Ankle Surgery

Rothman Institute Orthopaedics1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2017年8月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
128
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

With the increasing rise of outpatient surgery in orthopaedic procedures, the management of immediate postoperative pain has been a major topic investigated, with the use of a peripheral nerve block in combination with general anesthesia being a commonly accepted method. Foot and ankle procedures, which offer the choice of several anesthetic techniques, have increasingly been performed with this method predominantly through the combination of general anesthesia with a single-injection popliteal nerve block to reduce the substantial acute postoperative pain that often requires large opioid intake within the post-anesthesia care unit (PACU). However, as a single-injection peripheral nerve block resolves off shortly following surgery, major postoperative pain, termed "rebound pain", can also arise, and has the potential to be even greater than that of patients who do not receive any peripheral nerve block with general anesthesia.

The purpose of this study is to evaluate the contribution of ropivacaine concentration (0.5% versus 0.25%) of the initial bolus in continuous popliteal nerve blocks toward the rebound pain phenomena, or the quantifiable difference in pain experienced during the initial time after block resolution, in foot and ankle surgeries.

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

  • All patients undergoing foot and ankle surgeries under the care of Dr. Steven Raikin with continuous popliteal blocks at Riverview Surgical Center will be considered for enrollment.

排除标准

  • Patients who present with a) known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type,
  • Existing use of narcotics,
  • Pregnant women,
  • Individuals under the age of 18
  • Procedures involving any other forms of anesthesia other than general anesthesia with a continuous popliteal nerve block.

研究组 & 干预措施

Standard Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.

干预措施: Ropivacaine 0.5% Injectable Solution (Drug)

Standard Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.

干预措施: Ropivacaine 0.25% Injectable Solution (Drug)

Standard Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.

干预措施: Percocet Pill (Drug)

Standard Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.

干预措施: Norco Pill (Drug)

Standard Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive an initial injection of 0.5% ropivacaine as the initial anesthetic followed by continuous injection of 0.25% ropivacaine.

干预措施: Foot/Ankle Surgery (Procedure)

Partial Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery

干预措施: Ropivacaine 0.25% Injectable Solution (Drug)

Partial Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery

干预措施: Percocet Pill (Drug)

Partial Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery

干预措施: Norco Pill (Drug)

Partial Popliteal Nerve Block

Active Comparator

Participants undergoing foot or ankle surgery will receive 0.25% ropivacaine initially followed by the usual continuous injection of 0.25% ropivacaine during surgery

干预措施: Foot/Ankle Surgery (Procedure)

结局指标

主要结局

Postoperative Pain

时间窗: 7 days

Participants Satisfaction with pain control will be measured using the Visual Analog Scale for Pain (VAS)

Postoperative Opioid Usage

时间窗: 7 days

For each group, participants will be asked to record their postoperative pain medication usage daily

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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