Comparison between Hyperbaric Bupivacaine with Fentanyl and Hyperbaric Levobupivacaine with Fentanyl in spinal anaesthesia for infraumbilical surgeries- a hospital based randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the onset and duration of sensory and motor blockade between 0.5% Hyperbaric Bupivacaine with 25mcg Fentanyl and 0.5% Hyperbaric Levobupivacaine with 25mcg Fentanyl for spinal anaesthesia in patients undergoing elective infraumbilical surgeries.
研究概览
简要总结
Spinal anaesthesia is the most commonly used anaesthetic procedure for patients undergoing surgeries for areas below the umbilicus like inguinal hernia, debridement and split skin grafting, hemorrhoidectomy, orthopaedic procedures of the lower limbs, amputations, hysterectomy, etc. It is most commonly performed using 0.5% Hyperbaric Bupivacaine in the present anaesthetic practice but Bupivacaine has disadvantages of Cardiovascular and Central nervous system toxicities.
Levobupivacaine, which is the pure S(-) enantiomer of racemic Bupivacaine has significantly decreased toxicological profile in comparison to Bupivacaine, especially the Cardiovascular and Central Nervous system toxicities. Previous data in literature showed not much differences between Levobupivacaine and racemic Bupivacaine with regard to onset time, duration and spread of sensory and motor blockades as well as to their hemodynamic effects. Isobaric Levobupivacaine has been widely studied in its clinical application in epidural anaesthesia, peripheral nerve blocks, local procedures and spinal anaesthesia, but more has to be known about Hyperbaric Levobupivacaine’s intrathecal administration and its effects.
The addition of low doses of Opioids to local anaesthetics during spinal anaesthesia for infraumbilical surgeries decreases the incidence of local anaesthetic related side effects and increases the quality of intra and post-operative analgesia by reducing the amount of local anaesthetic agent administered.
Opioids like Fentanyl can be combined with local anaesthetics for spinal anaesthesia and it prolongs the duration of action and spread of motor block as well.
The plan of this study is to compare the onset and duration of action of Hyperbaric Bupivacaine with Fentanyl and Hyperbaric Levobupivacaine with Fentanyl, evaluate the hemodynamic changes. The aim is to compare the efficacy of low dose local anaesthetic agent when used along with opioids to decrease the side effects associated with these local anaesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients undergoing infraumbilical surgeries under spinal anaesthesia.
- •2.ASA grade I and II.
- •3.Patients willing to give informed consent.
排除标准
- •1.Hypersensitivity to any of the drugs under study.
- •2.Non-consenting or unable to give consent.
- •3.Patients with any contraindication to spinal anaesthesia.
- •4.Patients who do not fulfill the inclusion criteria.
结局指标
主要结局
To compare the onset and duration of sensory and motor blockade between 0.5% Hyperbaric Bupivacaine with 25mcg Fentanyl and 0.5% Hyperbaric Levobupivacaine with 25mcg Fentanyl for spinal anaesthesia in patients undergoing elective infraumbilical surgeries.
时间窗: From the time of drug administration till upto 4 hours.
次要结局
- To study the hemodynamic changes.(From the time of drug administration till upto 4 hours.)
研究者
Jennifer Konsam
Jawaharlal Nehru Medical College