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临床试验/CTRI/2025/03/082125
CTRI/2025/03/082125尚未招募Phase 3 4

Evaluation of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in subarachnoid block: a comparative study

Department of Anaesthesiology School of Medical Sciences and Research, Sharda University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年3月21日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
1. Time of onset and duration of sensory blockade assessed by pinprick and Visual Analog Score (VAS).

研究概览

简要总结

Neuraxial anesthesia is commonly performed for all surgical procedures carried on lower abdomen, pelvis and lower limbs to provide adequate surgical anesthesia and analgesia. It has a definite advantage over general anesthesia by blocking nociceptive impulses from the operative site, reduced blood loss and decreased incidence of deep vein thrombosis. Levobupivacaine has become popular for central neuraxial blocks in this century. The main advantage includes ease of technique and reliability. Levobupivacaine a pure s-enantiomers of bupivacaine are safer alternative for regional anaesthesia than its counterpart with lower toxicity profile. Opioids are added to local anesthetic drugs intrathecally to provide synergistic effect and to improve the quality of intraoperative and postoperative analgesia. These agents when combined together result in a reduction in the dose of both classes of drugs, decreasing the likelihood of side effects related to each.

Extensive search of literature reveals that though the studies have been conducted with our additives with the drug bupivacaine, but a specific study comparing the additive effect of both the drugs with the recently introduced drug Levobupivacaine and a suitable dose required intrathecally has not been done extensively. Therefore, the present study is designed to compare the effect of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in subarachnoid block.

The specific outcome measures to define the performance of our study will primarily include comparing the effect of both the adjuvant drugs administered on the duration of motor and sensory blockade.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient scheduled for surgery under subarachnoid block 2.Age 18-60 years
  • Both genders
  • ASA grade I and II.

排除标准

  • 1.ASA grade III and IV 2.Patient refusal to participate in study 3.Morbid obesity
  • Patient with history of adverse response to study drugs
  • Patient with pre-existing neurological or spinal disease, cardiovascular disease, renal, hepatic or any other systemic disease.
  • Pregnant females 7 Coagulopathy or bleeding diathesis.

结局指标

主要结局

1. Time of onset and duration of sensory blockade assessed by pinprick and Visual Analog Score (VAS).

时间窗: Post operative period

2. Time of onset and duration of motor blockade assessed by modified Bromage scale.

时间窗: Post operative period

To compare the effect of intrathecal nalbuphine versus butorphanol as an adjuvant to 0.5% Levobupivacaine in subarachnoid block in respect to:

时间窗: Post operative period

次要结局

  • 1. Changes in vitals parameters-(Heart rate (HR), Noninvasive Blood Pressure (NIBP) & Oxygen Saturation (SPO2).)

研究者

发起方
Department of Anaesthesiology School of Medical Sciences and Research, Sharda University
申办方类型
Private medical college

研究点 (1)

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