Post Hysterectomy Pain Prevention: Randomized Clinical Trial of High Volume Preoperative Wound Infiltration and Pain Specific Anesthetic Protocol Versus Standard of Care (no Wound Infiltration and Routine Anesthetic Protocol)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Post Operative Morphine
研究概览
简要总结
The study is a blinded randomized clinical trial, comparing policies of high volume preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no wound infiltration and routine anesthesia) for post operative pain management after hysterectomy. Morphine use and pain will be measured during index admission, and pain will also be measured six weeks postoperatively. The study will be conducted at a single site, Rockyview General Hospital.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women may be included if they require total abdominal hysterectomies (+/- BSO) at Rockyview hospital.
排除标准
- •have endometrial cancer,
- •require a vertical midline incision,
- •have any additional surgery planned
- •have a contraindication to morphine, Magnesium Sulfate, Dexmethasone, Lidocaine or Marcaine
- •have difficulty communicating in English
研究组 & 干预措施
Standard of Care
Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol).
干预措施: Standard of care (Procedure)
Pre-emptive wound infiltration
The Wound Infiltration Group will receive 100 mL 0.25% marcaine plain distributed as follows: 50 mL subcutaneously prior to skin incision along entire length of planned incision line, 50 mL subfascially prior to fascial incision, with 10 mL infiltrated directly into the rectus muscles bilaterally.
干预措施: Pre-emptive wound infiltration (Procedure)
结局指标
主要结局
Post Operative Morphine
时间窗: For the entire post-operative hospital admission (3 days on average)
The amount of post operative morphine (PCA IV) will be recorded from the PCA device each day by the Acute Pain Service Nurses. The total dose (mg morphine) will be recorded for each 24 hour period, and summed for the complete postoperative period of admission.
次要结局
- Time in recovery (hours)(Until discharge from recovery (on average 2 hours))
- Morphine use in recovery(Until discharge from recovery (on average 2 hours))
- Adverse events as a result of morphine overdosage(Until discharge from recovery (on average 2 hours))
- Change in pain score(baseline - 6 weeks post-operative)
- Pain measurement using Visual Analogue Scale (VAS) post operatively(Daily until discharge (3 days on average))
研究者
Wynne Innez Leung
Clinical Assistant Professor, General
University of Calgary