Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites, a Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Numeric Rating scale for pain assesment during the first postoperative 12 hours
研究概览
简要总结
Background: Skin grafting; both partial and complete thickness is frequently used in reconstruction of traumatic soft tissue defects. It is of great value not only for functional and aesthetic purposes in the field of plastic surgery, but also for other surgical specialties.
Of all the problems in the early postoperative period, pain is considered the most important, ameliorating it can lead to significant reduction in postoperative morbidity and faster recovery of the skin donor site.
Objective: To evaluate use of dexamethasone as adjuvant for bupivacaine in subcutaneous local anesthesia infiltration for skin graft donor sites, on quality of pain relief and total dose of analgesic requirements in the early hours postoperatively.
Methods: 97 patients were randomly allocated to receive local bupivacaine infiltration (group LB), or dexamethasone plus bupivacaine (group LB + D) in skin donor site after skin harvesting. In addition to basic demographic data; patients were compared for Numerical Rating Scale (NRS), total dose of morphine or morphine equivalents, time to 1st breakthrough pain, and duration of surgery.
Keywords: Donor site. skin graft. Breakthrough pain. Rescue analgesia. Bupivacaine
详细描述
The patients included in the study were randomly allocated to 1 of 2 parallel groups: 1) bupivacaine plus dexamethasone (LB+D) group (n = 50): received 20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml, 2) bupivacaine only (LB) group (n = 50): received 20 ml bupivacaine 0.5% + 20 ml normal saline. A random allocation sequence was generated electronically using online randomization service from https://www.random.org. The project medicine was prepared by 2 independent assistants not involved in other parts of the study. All persons involved were blinded to the randomized allocation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anesthesiologists Physical Status classification I-II and scheduled for split thickness skin grafting to cover full thickness skin burn or degloving injury after trauma.
排除标准
- •were inability to cooperate.
- •immunosuppressive therapy.
- •Body Mass Index >
- •diabetes.
- •lower-limb neuropathy.
- •daily intake of glucocorticoids or opioids.
- •patients who need area of coverage more than 10 cm
- •allergy to any drug used in the study.
- •alcohol or drug abuse.
- •American Society of Anesthesiologists Physical Status classification III or more.
研究组 & 干预措施
GROUP X(xylocaine)
20 ml bupivacaine 0.5% + 20 ml normal saline.
干预措施: Xylocaine (Drug)
GROUPX(Dxylocaine and dexamethasone)
20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml
干预措施: Xylocaine (Drug)
结局指标
主要结局
Numeric Rating scale for pain assesment during the first postoperative 12 hours
时间窗: 4 MONTHS
TREATMENT
次要结局
未报告次要终点
研究者
RAMY AHMED
lecturer of anesthesia at faculty of medicine ain shams university
Ain Shams University