Comparison of Analgesic Efficacy of Intrathecal Levobupivacaine With and Without Oral Tizanidine in Lower Limb Surgeries: A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Onset of action
研究概览
简要总结
Tizanidine, alpha-2 adrenergic receptor agonist, provides analgesic and hemodynamic benefits, which could enhance the efficacy of local anaesthetics. This randomized controlled trial examines the effectiveness of oral tizanidine as an adjunct to intrathecal levobupivacaine for spinal anaesthesia in lower limb surgeries
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18 to 60 years with an ASA grade of I-II, who were scheduled for elective lower limb surgeries with a duration of less than 2 hours and 30 mins.
排除标准
- •Patients with certain conditions such as pregnancy, coagulopathy, cerebrovascular disease, systemic infections, inability to understand the study protocol, allergy to local anaesthetics, psychiatric disorders affecting evaluation, infection at the injection site, kidney and liver diseases, myelopathy or peripheral neuropathy, spinal stenosis, prior spinal surgeries, raised intracranial pressure, multiple sclerosis, spina bifida, those receiving thromboprophylaxis and refusal to participate in the study were excluded.
研究组 & 干预措施
Tizanidine group
Group T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery
干预措施: Tizanidine (Drug)
placebo
No active drug will be given per oral
干预措施: Tizanidine (Drug)
结局指标
主要结局
Onset of action
时间窗: intraoperative period after the spinal anaesthesia was given
The duration of the sensory block was measured using the two-segment regression method, while the time until the first need for pain relief after surgery was used to determine the duration of analgesia. The modified Bromage scale was used to assess motor block. (0 = Ability to flex hips, knees, and ankles without paralysis; 1 = the ability to move the knees but not extend the legs; 2 = ability to flex at the ankles but not the knees; 3 = unable to move any part of the lower limb). The time between the injection and the highest Bromage score was used to determine the onset time of motor block.
次要结局
- pain score(intraoperative and post operative period up to 24 hours)
研究者
ADABALA VIJAY BABU
ABabu
All India Institute of Medical Sciences