Sacral Canal Block for Hip Replacement the Efficacy and Safety of Controlled Intraoperative Hypotension:a Single-center, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The onset time for blood pressure to drop from the basal blood pressure to the controlled antihypertensive target value
研究概览
简要总结
To observe the efficacy and safety of sacral canal block in controlled blood pressure reduction during hip replacement in the elderly, and to provide a better option for controlled blood pressure reduction during clinical hip surgery.
详细描述
Confirm the effectiveness of sacral canal block in controlled blood pressure reduction during hip replacement surgery in the elderly.
The patient underwent sacral canal block 30 minutes before the operation. The time from the start of the block to achieving the target blood pressure for controlled blood pressure reduction, the duration of the target blood pressure, and the blood pressure variability at different time points were observed. The blood pressure variability was used to evaluate the effect of controlled blood pressure reduction during the operation, the intraoperative blood loss, and the surgeon's satisfaction. It has been confirmed that sacral canal block can effectively achieve the purpose of controlled blood pressure reduction in hip replacement surgery for the elderly.
Clarify the safety of sacral canal block for controlled hypotension in hip replacement surgery.
The patient underwent sacral canal block 30 minutes before the operation. Observe from the start of the block to the regression of the block plane, and the patient was lowered Limb tissue oxygen saturation, peripheral perfusion index, unexpected hypotension, heart rate variability, pulse oxygen saturation, and whether there are complications related to sacral canal block such as local anesthetic poisoning, general spinal anesthesia, regional nerve injury, epidural hematoma, puncture site infection, etc. Meanwhile, the general information of the patients was recorded, including the duration of the operation, the consumption of opioids during the operation, the postoperative pain score, the incidence of nausea and vomiting, and the recovery of sensorimotor sensation in the postoperative block plane regression of the patients, etc. It is clear that sacral canal block can be safely used for controlled blood pressure reduction during hip replacement surgery in the elderly.
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, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 45 years old;
- •ASA Grade II - III;
- •BMI 18-35kg/㎡;
- •Agree to participate in this study and sign the informed consent form.
排除标准
- •Those who refuse to participate in the experiment;
- •Those who suffer from language or hearing impairments and are unable to communicate;
- •Those with contraindications for sacral canal block.
研究组 & 干预措施
General anesthesia group(NCB Group)
Conventional general anesthesia was adopted, and laryngeal mask general anesthesia was only administered to the patient.
干预措施: Simple general anesthesia (Procedure)
Sacral canal block + General anesthesia group (CB group)
Thirty minutes before the start of the operation, 30ML of the pre-prepared 0.375% ropivacaine was injected into the sacral canal under ultrasound guidance, and the diffusion of the local anesthetic in the sacral canal could be observed.
干预措施: Sacral canal block combined with general anesthesia (Procedure)
结局指标
主要结局
The onset time for blood pressure to drop from the basal blood pressure to the controlled antihypertensive target value
时间窗: during surgery
The onset time of blood pressure change from the basal blood pressure to the controlled blood pressure reduction target value (systolic blood pressure lower than or equal to 90mmHg or MAP60-70mmHg), the maintenance time of the target blood pressure value, the blood pressure values at each time point, and the intraoperative blood loss.
次要结局
- Oxygen saturation of the lower extremity tissue on the healthy side（%）(during surgery)
- Peripheral perfusion index(during surgery)
- heart rate(times/minute)(during surgery)
- Intraoperative blood loss（Milliliters）(Day 1)
- The cumulative dosage of anesthetic drugs used(Day 1)