The Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Successful Reliable Saddle Block for Minor Perianal Surgeries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Minimal Effective Dose of Hyperbaric Bupivacaine
研究概览
简要总结
The optimal anesthetic technique would provide excellent operating conditions, rapid recovery, early discharge, no postoperative side effects, and high patient's satisfaction. In addition to increasing the quality and decreasing the costs of the anesthetic services (1). Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a specific type of surgery - has become very popular technique) 2(for some orthopedic and gynecological surgeries [3-9].
Saddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries (11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle block (11, 12).
Although Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have been used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose has yet to be determined.
The objective of this study is to determine the minimal effective dose of hyperbaric spinal bupivacaine required to induce a reliable and satisfactory saddle block for perianal surgeries (using a modified Dixon's up-and-down method.
详细描述
Following approval of the Research and Ethics Committee of the University of Dammam and written informed consent, patients with American Society of Anesthesiologists physical Status I and II, aged 20-55 years, scheduled for outpatient elective perianal surgery in the lithotomy position ( hemorrhoidectomy, fistulectomy), were prospectively enrolled in this study. Patients unwilling to participate, those with contraindications to regional anesthesia, morbid obesity, bleeding disorders, mental health problems or language barriers, taking psychotropic or analgesic medication, or a known history of allergic reactions to amide local anesthetics, were excluded from the study.
Actually, 35 patients were enrolled. However; after they have signed the informed consent; 7 patients were excluded because they have received analgesics in the morning of surgery, and 4 patients refused to receive the saddle block on the operating room. So actually 24 patients out of 35 participants underwent intervention
All patients were fasted for over 6 hours and were premedicated with 0.2 mg/kg oral diazepam 60 min before spinal anesthesia.
In the operating room (OR), an intravenous (IV) 18-20G catheter was placed, and standard monitoring [electrocardiogram (ECG), heart rate (HR), oxygen saturation (SpO2), and noninvasive blood pressure (NIBP)] were started.
Under aseptic conditions, the dural puncture was performed by staff-grade anesthesiologists, using a standard midline approach in the sitting position at the L3-L4 or L4-L5 intervertebral space, using a 25-gauge Whitacre needle with its orifice directed caudally. A predetermined small dose of hyperbaric bupivacaine (Marcaine Spinal Heavy; Astra Zeneca, Lund, Sweden) which was prepared in1 mL tuberculin syringe was injected. All patients remained in the sitting position for 10 min. the patient was asked if he/she perceived any change in motor power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical Status I and II patients.
- •Scheduled for outpatient elective perianal surgery.
排除标准
- •Patients unwilling to participate.
- •Contraindications to regional anesthesia.
- •Morbid obesity.
- •Bleeding disorders.
- •Mental health problems.
- •Language barrier.
- •Taking psychotropic or analgesic medication.
- •History of allergic reactions to amide local anesthetics.
研究组 & 干预措施
Saddle block
The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method
干预措施: Dixon's up-and-down method (Drug)
结局指标
主要结局
Minimal Effective Dose of Hyperbaric Bupivacaine
时间窗: 10 min after dural puncture
the minimal effective dose of hyperbaric bupivacaine using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.
次要结局
- Motor Block Score as Assessed Using the Bromage Scale(every 30 min until Time to ambulation (approximately 2 hours))
- Sacral Level of Sensory Block(every 30 min until complete regression of the block (approximately 90 min))
- Patient's Satisfactions(24 hours after surgery)
- Surgeon's Satisfactions(24 hours after procedure)
