The Analgesic Efficacy of the Transversalis Fascia Plane Block in Iliac Crest Bone Graft Harvesting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
Hand or wrist surgery often requires the use of bony material in order to accomplish any associated reconstructive aspects required for the surgery. The iliac crest is often used as the source of bone for such surgery and harvesting from this site is performed simultaneously with the hand/wrist surgery. In terms of anesthesia, patients typically receive a supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the bone graft, though spinal block may also be performed. This study will look at the use of a transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac crest) in combination with a general anesthetic to see if post-operative pain and opioid consumption is reduced using the TFP block.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III
- •18-85 years of age, inclusive
- •Weight 50kg+
- •Scheduled for elective upper limb surgery, which can be solely performed under a brachial plexus block, and requiring an ICBG
排除标准
- •Contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- •History of alcohol or drug dependency/abuse
- •History of long term opioid intake or chronic pain disorder
- •History of significant psychiatric conditions that may affect patient assessment
- •Failure of upper extremity block
- •Previous iliac crest bone grafting
- •History of severe pelvic and hip conditions that could interfere with the long-term functional assessments of the study
- •Inability to understand the informed consent and demands of the study.
研究组 & 干预措施
Active treatment group
Ultrasound-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine
干预措施: Active treatment (Drug)
Placebo arm
Ultrasound-guided TFP block with 20ml of 5% dextrose solution
干预措施: Placebo Arm (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 24 hours
Opioid consumption in the first 24 hours following ICBG. This will be expressed in terms of milligrams doses of IV morphine. Where other opioids are used, the doses will be converted to the equivalent IV morphine dose using standard opioid dosage conversion tables.
次要结局
- Opioid consumption(7 days)
- Complications(12 months)
- Pain measures(48 hours)
- Time of block performance(6 hours)