Comparison of Hyperbaric Ropivacaine versus Hyperbaric Bupivacaine in subarachnoid block for gynecological surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Assessment of sensory block will be done using
研究概览
简要总结
A total of 76 patients undergoing elective surgery will be randomly allocated to two groups of
38 patients each using computer generated random number table and the allotted number will
be secured in a coded opaque sealed envelope. The patients will be allocated to one of the
following two groups:
Group R (n=38): Patients will be given 3ml of 0.75% Hyperbaric Ropivacaine intrathecally
Group B (n=38): Patients will be given 3ml of 0.5% Hyperbaric Bupivaciane intrathecally
Procedure on day of surgery:
Patient will be shifted to the operation room. Monitoring of heart rate, systolic blood
pressure, diastolic blood pressure, mean arterial blood pressure, continuous
electrocardiogram, respiratory rate, and arterial oxygen saturation (Spo2) will be done using
multichannel monitor (Aespire view, GE Healthcare , Madison, WI, USA). Baseline values will be recorded.
After subarachnoid block has been given, assessment of sensory block will be done using sterile
pin prick method and motor blockade will be done using Modified Bromage scale. Assessment will
be done every minute for the first 10 minutes and then every 10 minutes during surgery and every
15 minutes postoperatively. Onset of both motor and sensory blockade will be assessed and
recorded. The highest dermatomal level of sensory blockade and recovery time of both sensory and
motor blockade will be recorded. Recovery time for the sensory blockade will be defined as the two
dermatome regression of anaesthesia from the maximal level.
Patients with a VAS score of > 3 will receive rescue analgesia. The time of first
request for analgesia postoperatively will be recorded as total duration of spinal analgesia.
Patient will be monitored continuously intra and post operatively and observations will be recorded
in the prescribed proforma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •Age group between 18-65 years American Society of Anaesthesiologists (ASA) physical status I and II of either sex BMI ≥ 20 to ≤ 35kg/m² Duration of surgery upto 2-2.5 hours in gynecological surgeries (I.e Vaginal hysterectomy, Cervical polypectomy, Tubal recanalisation, Myomectomy, Dilatation and evacuation).
排除标准
- •Pre- existing local infection at the site of subarachnoid block Patients with coagulopathy and platelet disorders Contraindication or allergy to study drugs Patients having pain in any other area than the surgery site Patients having sensory or motor problem in the lower limb Patients who failed to understand the VAS scoring system Pregnant and lactating women Patients with current history of psychiatric illness, communication difficulties.
结局指标
主要结局
Assessment of sensory block will be done using
时间窗: Time interval from onset of motor block to attainment of | complete movements (Bromage 0) in both lower limbs-motor blockade will be | assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery | and every 15 minutes postoperatively.
injecting the drugs intrathecally
时间窗: Time interval from onset of motor block to attainment of | complete movements (Bromage 0) in both lower limbs-motor blockade will be | assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery | and every 15 minutes postoperatively.
Comparison of duration of motor block after
时间窗: Time interval from onset of motor block to attainment of | complete movements (Bromage 0) in both lower limbs-motor blockade will be | assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery | and every 15 minutes postoperatively.
assessed using Modified Bromage scale.
时间窗: Time interval from onset of motor block to attainment of | complete movements (Bromage 0) in both lower limbs-motor blockade will be | assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery | and every 15 minutes postoperatively.
sterile pin prick method and motor block will be
时间窗: Time interval from onset of motor block to attainment of | complete movements (Bromage 0) in both lower limbs-motor blockade will be | assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery | and every 15 minutes postoperatively.
次要结局
- Comparison of onset of sensory and motor block, peak level, time to 2 segment regression,(duration of effective analgesia and any side)