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临床试验/NCT02991404
NCT02991404已完成早期 1 期

Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月17日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Pain scores

研究概览

简要总结

Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either multimodal single injection adductor canal block with sham infusion catheter or continuous infusion of local anesthetic (control) for postoperative analgesia.

Primary end point is pain scores at 30 hours post performance of block procedure.

详细描述

The objective of this study is to determine if a single shot multimodal peripheral nerve block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will provide comparable (equivalent) analgesic control when compared to an adductor catheter. The primary end point will be pain scores at 30 hours post block initiation. Secondary end points will include, opioid consumption, time to first analgesic request; pain scores; binary patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative nausea, and vomiting.

Methods and Measures Design The study will be a randomized, double-blind, sham catheter study. Patients will be recruited and randomized to one of two groups: The "Treatment Arm" receive a single shot adductor canal block containing 20 milliliters (ml) of solution including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm. The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in the current pump in use at our hospital). An opaque bag will be placed over the pump for blinding purposes. The "Control Arm" will receive an adductor canal catheter through which they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will be placed over the control arm pumps in similar fashion. For all patients, the order in the electronic medical record will be per research pharmacy protocol. For their primary anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic or general anesthetic per the anesthesiologist in the operating room.

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
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • Patients will be eligible for inclusion in the study if they are:
  • Age of 18 years old or older
  • Scheduled to primary unilateral total knee arthroplasty.
  • Patients must give written informed consent for anesthesia including continuous adductor canal block for postoperative analgesia prior to recruitment

排除标准

  • Patients will be excluded if they have:
  • A contraindication to an adductor canal block or catheter placement including, but not limited to site infection, irritation, or refusal.
  • Poorly controlled diabetes (A1C >8.0)
  • Allergy to medications involves in this study (opioids, bupivacaine, buprenorphine, clonidine, or dexamethasone)
  • Opioid use >40 mg of oxycodone daily, long-acting opioids.

研究组 & 干预措施

Continuous adductor canal block

Active Comparator

After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.

Multimodal peripheral nerve block injection.

干预措施: Multimodal Peripheral Nerve Block Injection (Procedure)

Continuous adductor canal block

Active Comparator

After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.

Multimodal peripheral nerve block injection.

干预措施: Initial Bolus (Drug)

Continuous adductor canal block

Active Comparator

After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.

Multimodal peripheral nerve block injection.

干预措施: Continuous infusion (Drug)

Single injection block with sham cath

Sham Comparator

Single Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group.

干预措施: Single Shot Adductor Canal Block (Procedure)

Single injection block with sham cath

Sham Comparator

Single Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group.

干预措施: Initial Bolus (Drug)

结局指标

主要结局

Pain scores

时间窗: 30 hours post block placement

At 30 hours pain scores between the two groups will be compared for determining statistically significant differences

次要结局

  • total opioid consumption(Through 30 hours post block)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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