Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section: Midline, Paramedian and Taylors Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Post-dural-puncture headache (PDPH)
研究概览
简要总结
The goal of this clinical trial is to compare different approaches of spinal anesthesia in pregnant females who are having cesarean section. The main aim is
• Which approach is better in terms of avoiding intraoperative and post operative complications
Participants will be given anesthesia by
- Midline approach
- paramedian approach
- Taylors approach
详细描述
- Introduction to study:
Different techniques and modalities are used to anesthetize the patient for the smooth conduction of surgery including, general anesthesia, spinal anesthesia, different types of regional anesthesia and monitored anesthesia care.1 According to the authors' knowledge, limited local studies are available that compare midline to the paramedian approach, Taylor's approach and Transforaminal approach of spinal anesthesia in the context of occurrence of post-dural puncture headaches, backache, hematoma, paresthesia, pulse, blood pressure, respiratory rate, temperature and urine output.3 2. Problem statement:
Post-dural puncture headache is defined as a bilateral headache that develops within 7 days after dural puncture. It characteristically worsens 15 minutes after resuming sitting position and improves or disappears within 30 minutes of resuming supine position. It can be managed with medical as well as autologous epidural blood patch. It may result in prolonged recovery and delayed mobilization as well as psychosomatic side effects. More sinister side effects like subdural hematoma and seizures are rare but may prove fatal.2 The exact mechanism of development of postdural puncture headache is unclear. The postulated pathogenesis involves cerebrospinal fluid (CSF) leak through the dural puncture site resulting in intracranial hypotension leading to traction on intracranial structures and vasodilatation of cerebral vessels resulting in headache.2 3. Objectives of this research:
i) To find out frequency of Post-dural puncture headache (PDPH) in patients with different groups undergoing different approaches of spinal anesthesia.
ii) Impact of different approaches of spinal anesthesia on complications of spinal anesthesia. Complications are related to either exaggerated physiologic responses or needle/catheter insertion and include:
- Post-dural-puncture headache (PDPH)
- Hypotension and bradycardia secondary to sympathetic blockade
- Hypothermia
- Respiratory failure resulting from a "high spinal/block"
- Urinary retention
- Spinal infection, including aseptic meningitis
- Spinal or epidural hematoma
- Nerve or spinal cord damage, possibly resulting in paralysis
- Pain iii) Impact of different approaches of spinal anesthesia on vitals (pulse, BP, temperature, respiratory rate, spO2 and urine output) intraoperatively and postoperatively.
- Limitation of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
盲法说明
Health care workers including nurses paramedical staff and ward boys may be masked from this study
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Exclusion Criteria:
- •Patients who refuse to participate in study.
- •More than 3 attempts of lumber puncture
- •Previously having migraines of PDPH
- •Hb less than 7
- •INR more than 1.2
- •Previous C-section more than 5
- •Patients with placenta previa, accrete, percreta and increta
- •NPO less than 6 hours preoperatively
- •Patients from gynecological department other than C-section
排除标准
- •Patients who refuse to participate in study.
- •More than 3 attempts of lumber puncture
- •Previously having migraines of PDPH
- •Hb less than 7
- •INR more than 1.2
- •Previous C-section more than 5
- •Patients with placenta previa, accrete, percreta and increta
- •NPO less than 6 hours preoperatively
- •Patients from gynecological department other than C-section
研究组 & 干预措施
Group M
It will involve participants who are given spinal anesthesia through midline approach.
干预措施: Midline Approach (Procedure)
Group P
It will involve participants who are given spinal anesthesia through paramedian approach.
干预措施: Paramedian Approach (Procedure)
Group T
It will involve participants who are given spinal anesthesia through Taylors approach.
干预措施: Taylors approach (Procedure)
结局指标
主要结局
Post-dural-puncture headache (PDPH)
时间窗: 1 month
PDPH is the most common complication after spinal anesthesia. Our study is based on prevention of PDPH using different approach in spinal anesthesia
次要结局
- Hematoma(5 days)
- Spinal Shock(1 day)
- Meningitis(1 month)
- Urinary retention(1 month)
- Hypotension and bradycardia secondary to sympathetic blockade(1 day)
- Hypothermia(1 day)
- Respiratory failure(5 days)
研究者
Muhammad Ali Fayyaz
Dr Muhammad Ali Fayyaz
Bahawal Victoria Hospital Bahawalpur