Efficacy of intrathecal fentanyl and hyperbaric ropivacaine (0.75 percent) administered as a mixture or sequentially in subarachnoid block in patients for perianal surgeries: a prospective comparative study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To note the onset and time taken to achieve maximum height of sensory and motor blockade of intervention and comparator agent
研究概览
简要总结
Subarachnoid block (SAB) is the most common regional anaesthesia technique done for infraumbilical surgeries due to its less cost and lower incidence of major perioperative complications, achieved by a limited and localised action of the drug. It offers an advantage of profound nerve block which can be achieved by injecting a small amount of local anaesthetic intrathecally. It is a reliable, effective and safe technique with predictable benefits, and has been the procedure of choice for perianal surgeries unless contraindicated.
Ropivacaine is an amide local anaesthetic. It blocks the nerve fibers which transmit pain (A delta and C fibers) to a greater degree than those fibers which are involved in motor function (A beta fibers). It has a shorter duration of sensory and motor block, thereby it minimizes the psychological discomfort of being immobile for longer duration. It also has reduced potential for neurotoxicity and cardiotoxicity, thus making it a choice for shorter outpatient procedures.
To prolong the duration of analgesia and decrease the adverse effects of high dose of local anaesthetic agents, adjuvants are commonly used. The neuraxial adjuvant of choice is fentanyl for its rapid onset and shorter duration of action due to its re-distribution
intrathecally. The combination of local anaesthetic with fentanyl is synergistic, which helps to enhance the block characteristics. The synergistic effect reduces visceral and somatic pain and the requirement for need of post operative analgesics.
Baricity is defined as the ratio of the density of local anesthetic and cerebrospinal fluid (CSF). The density of cerebrospinal fluid (CSF) at 37°C is 1.00059 g/ml while that of fentanyl is 0.99410 g/ml. The baricity of hyperbaric ropivacaine is 1.02980 g/ml which is almost close to that of CSF.
Mixing hyperbaric local anaesthetic with adjuvants in a single syringe for intrathecal administration is a common practice. This premixed solution alters the density of local anaesthetic solution affecting its spread in the CSF. Whereas, when the local anaesthetic solution and adjuvant is administered sequentially it minimizes the change in density and pH of both drugs, hence preventing any alteration in CSF spread.
Hence the rationale behind performing this study to see differences in block characteristics of Hyperbaric Ropivacaine (0.75%) with Fentanyl (25 mcg) administered as a mixture and as sequentially. Also the haemodynamic parameters and duration of post
operative analgesia will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are posted for perianal surgery belonging to ASA 1 or 2.
排除标准
- •Patients who have coagulation or bleeding disorders Patients with raised intracranial pressure Local site infection Patient refusal Known allergy to the study drug H/o spine surgeries, patient with spine deformity BMI greater than 35kg/m2.
结局指标
主要结局
To note the onset and time taken to achieve maximum height of sensory and motor blockade of intervention and comparator agent
时间窗: At baseline, at 2minutes, at 4minutes, at 6minutes, at 8minutes, at10minutes
次要结局
- To assess total duration of sensory & motor blockade(At 2nd hour postoperative, at 4th hour postoperative, at 6th hour postoperative, at 8th hour postoperative, at 12th hour postperative.)
- To note time required for first rescue analgesia(At 4th hour postoperative, at 6th hour postoperative, at 8th hour postoperative, at 12th hour postperative.)
- To assess haemodynamic parameters & adverse events(At baseline, at 2nd hour postoperative, at 4th hour postoperative, at 6th hour postoperative, at 8th hour postoperative, at 10th hour postperative, at 12th hour postoperative)
研究者
Dr Aakifah Mariam
Dr B R Ambedkar Medical College and Hospital