Comparative Study Between Nalbuphine V/S Magnesium Sulphate As An Adjuvant To Intrathecal Hyperbaric Levobupivacaine In Infraumbilical Abdominal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison of block characteristics in terms of Time taken for onset of sensory and motor blocks. Duration of sensory and motor blocks
研究概览
简要总结
TITLE- COMPARATIVE STUDY BETWEEN NALBUPHINE V/S MAGNESIUM SULPHATE AS AN ADJUVANT TO INTRATHECAL HYPERBARIC LEVOBUPIVACAINE IN INFRAUMBILICAL ABDOMINAL SURGERIES
Introduction - Regional anaesthesia (RA) significantly reduces pre- and postoperative side effects and is preferred over general anaesthesia due to fewer complications, early onset, and specific action. Spinal anaesthesia, widely used for infraumbilical surgeries, offers reversible sensory, motor, and sympathetic blockade with minimal systemic effects, utilizing hyperbaric, isobaric, or hypobaric solutions. Levobupivacaine, a safer S(-) enantiomer of bupivacaine, has lower cardiotoxicity and neurotoxicity, acting through sodium channel blockade. Nalbuphine, a semisynthetic opioid with μ antagonist and Κ agonist effects, enhances analgesia with minimal side effects when used intrathecally. Magnesium, via NMDA receptor antagonism, supports pain modulation but has limited CSF penetration.
Hypothesis -
Null Hypothesis:
Adjuvant use of Nalbuphine is equal in every aspect to MgSO4
for comparison when given with levobupivacaine.
Alternate Hypothesis:
Adjuvant use of Nalbuphine provides better block characteristics as
compared to MgSO4.
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
- •ASA-1 and ASA-2 Age 18yrs to 60 yrs.
排除标准
- •Patient Refusal Pregnancy Obesity Contra Indication to Spinal Anaesthesia Allergy to Study Drug Patients with Cardiac, Liver and Renal Disease Previous Surgery of Lumbar Spine.
结局指标
主要结局
Comparison of block characteristics in terms of Time taken for onset of sensory and motor blocks. Duration of sensory and motor blocks
时间窗: Assess the heart rate, blood pressure, oxygen saturation and MAP
次要结局
- Duration of analgesic effect, Peak VAS pain scores during recovery period, Total amount of rescue analgesia used. Post-operative hemodynamic changes.(Assess the VAS Score , Vitals in Post-operative period every 30 mins till 2 hours and every 1 hour till 12 hours, time taken for first rescue Analgesia.)
研究者
Dr Samundra Saini
Hind Institute of Medical Sciences