Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Visual Analog Scale Pain Score
研究概览
简要总结
The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis is that there will be no difference in overall pain scores or medication requirements when patients receive a saline, control injection and pain medications, compared to when their dressings are changed with a lidocaine injection into the sponge, with pain medications. Our objective is to disprove this null hypothesis with statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •wounds to which a split-thickness autologous skin graft applied;
- •infected wounds after debridement;
- •open fracture wounds;
- •acute soft-tissue wounds (with exposed tendon, bone, hardware, and/or joint);
- •fasciotomy wounds after compartment syndrome;
- •chronic non-healing wounds;
- •surgical wounds that are difficult to close due to tension; or
- •wounds with external fixation pins or tubes with irritation or drainage.
排除标准
- •allergy to lidocaine;
- •allergy to the polyurethane foam or impermeable seal;
- •malignancy associated with the wound;
- •extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein);
- •pregnancy as diagnosed by urine pregnancy test.
研究组 & 干预措施
Lidocaine then Placebo-Saline
干预措施: Lidocaine (Drug)
Lidocaine then Placebo-Saline
干预措施: Placebo-Saline (Drug)
Placebo-Saline then Lidocaine
干预措施: Lidocaine (Drug)
Placebo-Saline then Lidocaine
干预措施: Placebo-Saline (Drug)
结局指标
主要结局
Visual Analog Scale Pain Score
时间窗: 20 minutes
Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).
次要结局
- Break-through Narcotic Requirement(20 minutes)