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临床试验/NCT01863940
NCT01863940终止不适用

Continuous Infusion of Local Anesthetic for Post-operative Pain Control in Ukraine

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
67
试验地点
1
主要终点
Pain Score with dressing changes

研究概览

简要总结

Ukraine is a newly sovereign country in Eastern Europe with a large burn population. With the collapse of the Soviet Union, burn programs have become decentralized and resources for maintaining facilities have dwindled. Patients frequently present with debilitating burn injuries and often do not receive necessary treatment secondary to limited resources and cost of treatment.

The investigators have established an annual medical mission, outreach clinic and telemedicine relationship with hospitals and burn centers in Ukraine in an effort to improve burn care. One focus is post-operative pain control. The investigators have noticed a pattern of anxiety with children from the Ukraine surrounding dressing changes which they believe this is secondary to inadequate pain control in the immediate post-operative period including the initial dressing changes.

The goal is to provide wound catheters with a continuous infusion of procaine in an attempt to reduce the pain experienced in the early post-operative period and specifically with dressing changes.

There will be 200 participants, 12-65 years old who are receiving reconstructive plastic procedure with split-thickness skin grafts from lateral thigh in the study. 100 will receive the standard pain management Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM regimen and 100 will receive wound catheters with continuous procaine infusion for 48 hours with the standard Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM available for breakthrough pain. Pain scores will be assessed prior to dressing change, during dressing changes and at 30 minutes and 1 hour after dressing change.

详细描述

There will be 200 participants, ages 12-65 years old who are receiving reconstructive plastic surgery with split-thickness skin grafts from the lateral thigh at 1 hospital in Ukrain. The first 100 will receive the standard pain regimen Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM and the following 100 will receive catheters with continuous procaine infusion for 48 hours with the standard pain regimen available for breakthrough pain. All participants must be expected to remain inpatient for 48 hours post-operatively.

Participants receiving continuous infusion of local anesthetic via a wound catheter will have the ON-Q PainBuster Post-Op Pain Relief System (I-Flow Corporation) tunneled subcutaneously while the patient is intra-operative. Catheter insertion sites will be covered with Steri-strips and covered with a transparent dressing to facilitate inspection of the insertion site for any erythema or discharge. Catheters will have a 10mL procaine 0.5% bolus intra-operative followed by an infusion delivered at 4-5mL/hr delivered by an elastomeric pump. Historically patients' pain complaints arise from skin graft donor sites rather then recipient sites.

Patients will be assessed for pain scores on a scale of 0-10 (0= no pain and 10= worst possible pain) prior to dressing changes, during and 1 hour after dressing changes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • those admitted for reconstructive surgery required split-thickness skin grafts from the lateral thigh as part of their management

排除标准

  • age less than 12 years
  • known allergy to local anesthetics
  • pseudocholinesterase deficiency,
  • documented history of dementia/psychosis/delirium
  • known neurologic conditions impairing pain sensation pathways
  • pregnant, and breast feeding woman due to Ukrainian requirements

结局指标

主要结局

Pain Score with dressing changes

时间窗: 1 hour with dressing changes over 48 hours

Patients will be asked to record a pain score prior to dressing changes, during dressing changes and 1 hour after dressing changes for a total of 48 hours until the wound catheter is removed

次要结局

未报告次要终点

研究者

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

Gennadiy Fuzaylov

Gennadiy Fuzaylov, M.D.

Massachusetts General Hospital

研究点 (1)

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