Comparison of Ultrasound and Anatomical Landmark Method in Spinal Anesthesia for Elective Cesarean Section in Super Obese Parturients With BMI ≥ 50 kg/m2. A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Procedure/Surgery: Ultrasound method group
- 疾病 / 适应症
- Obesity, Morbid
- 发起方
- Karaman Training and Research Hospital
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The success rate of the first puncture
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This study will investigate whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the sitting position in super obese pregnant women with BMI ≥ 50 who will undergo elective cesarean section.
The primary objective of this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in super obese (BMI ≥ 50 kg/m2), pregnant women, according to the Who classification, whose topographic anatomy is difficult.
详细描述
Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may struggle to determine the poorly palpable surface landmarks in super obese (BMI ≥ 50 kg/m2) pregnant women. The manual palpation technique, preferred in neuraxial anesthesia, may be very difficult in super obese pregnant women due to difficulty identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease the number of attempts in obese parturients. This study will be a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. The anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups. Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 60 ultrasound-guided neuraxial blocks.
研究者
入排标准
入选标准
- •Parturient who will receive selective cesarean delivery under spinal anesthesia
- •ASA 3 scheduled for elective sections
- •BMI≥50 kg/m2
- •Normal singleton pregnancy
- •37 weeks of gestation
排除标准
- •Multiple gestations
- •Emergency C-section
- •Exist contraindications of spinal anesthesia
- •Local anesthetics allergy
- •BMI\<50 kg/m2
- •History of lumbar spinal diseases and lumbar surgery
- •Parturient refusal
研究组 & 干预措施
Ultrasound method group
The ultrasound-assisted technique will be used for spinal anesthesia performance.
干预措施: Procedure/Surgery: Ultrasound method group
Landmark method group
Land-mark assisted technique will be used for spinal anesthesia performance.
干预措施: Landmark method group
结局指标
主要结局
The success rate of the first puncture
时间窗: 30 minute
Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.
次要结局
- Time taken for spinal injection(30 minute)
- Number of puncture levels(30 minute)
- incidence of postoperative headache(72 hours)
- Failure rate of spinal anesthesia(120 minute)
- Incidence of hypotension(2 hours)
- dermatome level of sensory block(10 minute)
- The procedure duration time(30 minute)
- Time interval to determine needle insertion site(30 minute)
- Number of needle pass(30 minute)
- Number of skin punctures(30 minute)
- Patient satisfaction The procedure duration(120 minute)
- incidence of complications during puncture(120 minute)