Lumbar Transversus Abdominal Plane (TAP) Block: Does Volume Make a Difference?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.
研究概览
简要总结
Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be injected after surgery. The aim of this study is to determine the effect of changes in the volume of the injection.
详细描述
Pain from a surgical incision happens in most patients. During the perioperative period, the use of the TAP block has been shown to reduce pain scores, opioid consumption and sedation scores. Also, there is a trend towards a reduction of post-operative nausea and vomiting. The aim of the block is to reach the distal nerve endings of the abdominal wall from T6 to L1 dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes. Currently, there is consensus about optimal procedure-specific volumes and local anesthetic concentrations for lumbar TAP blocks. This is a pilot study and the purpose being is it feasible to do a large scale clinical study to determine the influence of increasing the local anesthetic volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-70 years old
- •total abdominal hysterectomy
- •capable of completing informed consent
- •no previous chronic opioid use
- •no previous abdominal wall surgeries
排除标准
- •patient refusal
- •contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders,
- •local or systemic infection
- •local anesthetic allergy
研究组 & 干预措施
20mLs of 0.5% ropivacaine per side
干预措施: Ropivacaine (Drug)
30mLs of 0.33% ropivacaine per side
干预措施: Ropivacaine (Drug)
40mLs of 0.25% ropivacaine per side
干预措施: Ropivacaine (Drug)
结局指标
主要结局
To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.
时间窗: 6 month
This will be shown as a number and a percenttage of patients recruited and randomized.
次要结局
- Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block.(48 hours)
- Pain scores at 2,6,12,24, and 48 hours post-block.(48 hours)
- Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block.(48 hours)
- Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours.(48 hours)
- Block failure rate.(48 hours)
- Patient's overall satisfaction.(48 hours)
- Discharge time from PACU.(24 hours)