Comparison of quality and recovery profile of subarachnoid block using either 0.5% hyperbaric, 0.5% isobaric or sequential hyperbaric followed by isobaric levo-bupivacaine : a double blind randomized comparative study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- To compare the highest level of sensory block achieved, the onset & duration of motor block achieved and the recovery from subarachnoid block given by using either 0.5% hyperbaric, 0.5% isobaric or sequential hyperbaric followed by isobaric levobupivacaine.
研究概览
简要总结
It is a prospective, double blind, randomised, comparative, hospital based study to be conducted by Department of Anaesthesia, Mahatma Gandhi Medical College & Hospital, Jaipur.
After ethical committee’s approval, informed written consent will be obtained from all patients. After doing all the required investigation, PAC will be performed a day before the surgery. Patients will be randomly divided into three groups of 35 each with the help of computer generated randomization tables method. All patients will be explained about the anaesthesia technique.
On the day of surgery patients will be shifted to operation theatre and all the monitors including pulse oximeter , ECG and non-invasive blood pressure will be attached and baseline parameters will be noted. Intravenous access will be obtained with 20 G cannula. A preload of 500 mL of Ringer Lactate 10 ml/kg solution will be administered.
All patients will be given subarachnoid block with 25G Quincke’s needle at L3-L4 intervertebral space in sitting position using a midline approach. Group A will be injected with 3 ml of hyperbaric 0.5% levobupivacaine, group B will be injected with 3 ml of isobaric 0.5% levobupivacaine and group C will be injected with 1.5 ml of hyperbaric 0.5% levobupivacaine followed by 1.5 ml of isobaric 0.5% levobupivacaine. The injection of local anaesthetic solutions will be done gradually over a period of 10-15 seconds after negative aspiration for blood and CSF accordingly. Immediately after spinal block all the patients will be placed supine.
The blinded anaesthesiologist will use the modified Bromage scale to check on the motor block every 5 minutes. The time needed to reach Bromage 3 before surgery and regress to Bromage 0 after surgery will be recorded. Hemodynamic parameters, sensory and motor blockade will be measured at baseline, 5, 10, 15, 20, 25, 30, 45, 60 and 120 minutes after the injection by the blinded anaesthesiologist.
Post-operative complications of subarachnoid block will be recorded and treated accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade I and II patients.
- •Patients posted for below umbilical elective surgeries.
- •Age between 18 years to 65 years.
- •BMI 17-30 kg/m2
- •Patients of all genders.
排除标准
- •Patient refusal for procedure.
- •Any bleeding disorder or patient on anticoagulants.
- •Surgeries prolonging more than 3 hrs.
- •Pregnant and lactating females.
- •Patients with failed spinal anaesthesia.
- •History of drug allergy.
- •Local infection at the injection site.
结局指标
主要结局
To compare the highest level of sensory block achieved, the onset & duration of motor block achieved and the recovery from subarachnoid block given by using either 0.5% hyperbaric, 0.5% isobaric or sequential hyperbaric followed by isobaric levobupivacaine.
时间窗: 1. Time of subarachnoid block administration. | 2. Sensory block onset (time taken to reach T10 level). | 3. Sensory block duration (2 segment regression of sensory level). | 4. Motor block onset (time taken to reach modified bromage score 3). | 5. Motor block duration (time taken in regression of modified bromage score to 0.
次要结局
- To assess intraoperative hemodynamics [Heart Rate(HR), Blood Pressure(BP), Mean Arterial Pressure(MAP), oxygen saturation(SpO2), Temperature].(At rest, 1min., 5min., 10min., 15min., 30min., 60min., 90min., 120min.)
- To assess postoperative pain score using Visual Analogue Scale (VAS) score.(At rest, 2nd hour, 4th hour, 8th hour, 12th hour, 16th hour, 24th hour.)
- To assess the time of first rescue analgesia (when VAS score is more than 4).(Time at which 1st analgesic was required postoperatively.)
- To assess any adverse events related to subarachnoid block.(For 24 hrs following surgery.)
研究者
Dr Eshan Mathur
Mahatma Gandhi Medical College and Hospital