SAFETY AND EFFICACY OF HYPERBARIC ROPIVACINE WITH FENTANYL VS HYPERBARIC BUPIVACAINE WITH FENTANYL IN INFRAUMBILICAL SURGERIES : A PROSPECTIVE RANDOMIZED CLINICAL STUDY
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
研究概览
简要总结
Spinal anaesthesia is a widely used and highly effective technique in modern anaesthesia, offering numerous advantages over general anaesthesia, such as reduced stress response, superior post-operative pain relief, and faster recovery times. These benefits make it particularly suitable for lower abdominal and lower limb surgeries.Bupivacaine, an amide local anaesthetic, has become the mainstay for spinal anaesthesia, owing to its potent and long-lasting effects. While it provides excellent sensory and motor block, bupivacaine’s prolonged motor block can delay recovery, making it less ideal for ambulatory surgeries where rapid motor function recovery is essential.Ropivacaine, a newer amide local anaesthetic, has emerged as a promising alternative. It shares many properties with bupivacaine but has a more favourable safety profile. Ropivacaine is less cardiotoxic and produces less motor block, allowing for quicker recovery of motor function, which makes it a suitable choice for day-care and ambulatory procedures.The addition of intrathecal opioids, such as fentanyl, to local anaesthetics has been shown to enhance the quality of spinal anaesthesia by intensifying the sensory block without increasing sympathetic block. This synergy allows for the use of lower doses of local anaesthetic, which further reduces the risk of side effects and facilitates earlier recovery.
Aim of the study is to Compare the efficacy of hyperbaric Ropivacaine plus Fentanyl vs hyperbaric Bupivacaine with Fentanyl.In this prospective clinical study, after approval from Institutional Ethical Committee and obtaining informed written consent, 128 patients of American Society of Anaesthesiologists (ASA) class I or class II of either sex, aged 18 - 65 years undergoing elective infraumbilical surgeries will be recruited. A thorough prospective clinical assessment done pre operatively.
Patients will be randomly allocated into two groups each containing 64 patients by computer generated random numbers.
Group L (n=64) will receive spinal anesthesia with 3ml of 0.5% hyperbaric bupivacaine with 20mcg of Fentanyl.
Group R (n=64) will receive spinal anesthesia with 3ml of 0.75% hyperbaric Ropivacaine with 20mcg of Fentanyl
After ensuring sterile conditions, spinal anaesthesia will be performed, and the patient will receive one of the two study drugs in sitting position, using 25G Quincke’s needle inserted at L3-L4 interspace. Drug will be injected and patient will be asked to lie down.
o The sensory block level evaluation – Pin Prick Method
o The motor block level evaluation – Modified Bromage Scale.
During the tracking of the sensory block in patients maximum sensory block level, time to achieve maximum sensory block, and it’s regression to L1 dermatome will be recorded.
Patients will be observed for any discomfort, nausea, vomiting, shivering, pruritus, bradycardia and any other side effects and the need for additional medications will be recorded.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Age of 18 to 65 years ASA Grade I and II Patients undergoing various infra-umbilical surgeries under spinal anaesthesia.
排除标准
- •Refusal of spinal anaesthesia Coagulopathies Head injury and raised ICP Psychiatric diseases Known allergy to test drug Infection at site of injection Uncorrected Hypovolemia Fixed cardiac output states Pregnant patients.
研究者
Dr Hiral Sanghvi
Dr D Y Patil School Of Medicine
