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临床试验/NCT02380417
NCT02380417已完成不适用

Paravertebral Catheter Use for Postoperative Pain Control in Patients After Lung Transplant Surgery: A Prospective Observational Study

University of Minnesota0 个研究点目标入组 33 人开始时间: 2013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
已完成
入组人数
33
主要终点
Maximal Pain score

研究概览

简要总结

This is a prospective observational trial of patient undergoing lung transplantation who have a thoracic paravertebral catheter(s) placed for postoperative pain control. Patients pain scores and opioid use were evaluated for 7 days after placement as well as any complications, opioid adverse events, and length of stay.

详细描述

Following approval of the University of Minnesota Institutional Review Board, 33 consecutive adult patients (≥ 18 years of age) were observed from October 2013 to December 2014 who underwent either single or bilateral lung transplantation and received a continuous paravertebral block. The paravertebral catheters were placed within 1-2 day postoperatively in the intensive care unit. If the patient was too hemodynamically unstable or too critically ill to be placed in lateral decubitus position, the placement of the catheter was delayed or in some cases not performed (these patients were not included in study) They were placed via an in plane transverse technique. The ultrasound was placed on the patient's back at the T8-9 level with probe in transverse orientation. Then a 17-gauge tuohy needle was advanced lateral to medial in plane until beneath the transverse process upon which a test dose of 3-5 mL of 1.5% lidocaine with 1:200,000 epinephrine was injected to see adequate spread. The catheter was then fed 1 centimeter past the tip of the tuohy needle and needle was withdrawn. All catheters were confirmed to be in correct position with real time local anesthetic injection and secured with skin glue and occlusive dressing. Each was performed with the patient in the left lateral decubitus position for the right catheter and right lateral decubitus position for the left catheter. The paravertebral catheters remained in place for up to seven days postoperatively in unilateral lung transplants and up to ten days postoperatively in bilateral lung transplants. During that time an infusion of 0.2% ropivacaine was infused at a rate of 0.2-0.25 ml/kg/hour through an elastomeric pump (ON Q Halyard Health).

The outcome measured were minimal and maximum pain scores from the first 7 days post paravertebral catheter placement (rated on an 11-point numeric rating scale; 0=no pain, 10=worst pain imaginable). The acute pain Nurse Practitioners, bedside nurses, or acute pain anesthesiology residents collected the pain scores. Additional outcomes of interest included postsurgical opioid use through postsurgical day 7, and length of hospital stay. Patients were asked daily if they experienced nausea/vomiting, however, Nursing notes and physician progress notes were also evaluated if patients experienced any adverse events or nausea and vomiting. Demographics such as age and weight were recorded in addition to length of surgery and time spent in the hospital before discharge.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • lung transplant
  • clamshell incision
  • received paravertebral catheter within 2 days of surgery

排除标准

  • non english speaking
  • remained intubated for greater than 3 days postoperatively
  • midline incision
  • allergy to local anesthetics

研究组 & 干预措施

Single lung transplant paravertebral catheter placement

Those patients who underwent single lung transplant either right or left.

干预措施: paravertebral catheter placement (Procedure)

Single lung transplant paravertebral catheter placement

Those patients who underwent single lung transplant either right or left.

干预措施: 0.2% ropivacaine (Drug)

Single lung transplant paravertebral catheter placement

Those patients who underwent single lung transplant either right or left.

干预措施: Elastomeric pump (Device)

bilateral lung transplant paravertebral catheter placement

those patients who underwent bilateral lung transplantation

干预措施: paravertebral catheter placement (Procedure)

bilateral lung transplant paravertebral catheter placement

those patients who underwent bilateral lung transplantation

干预措施: 0.2% ropivacaine (Drug)

bilateral lung transplant paravertebral catheter placement

those patients who underwent bilateral lung transplantation

干预措施: Elastomeric pump (Device)

结局指标

主要结局

Maximal Pain score

时间窗: each post catheter day from postoperative day 1 to day 7

VAS pain scores assessed by bedside nurse on 0-10 scale which is maximum felt

次要结局

  • Minimal Pain score(each post catheter day from post operative day 1 to day 7)
  • total opioid use(each post catheter day from postoperative day 1 to day 7)
  • number of patients with nausea in the postoperative period(from day of surgery evaluated up to post catheter day 7)
  • length of stay(from end of surgery evaluated until patient left hospital with expected average up to 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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