跳至主要内容
临床试验/CTRI/2023/03/050389
CTRI/2023/03/050389尚未招募不适用

Hyperbaric Bupivacaine with Nalbuphine and Buprenorphine Intrathecally for Postoperative Analgesia in Lower Abdominal and Lower Limb Surgeries : A Randomised Control Trial

ROHILKHAND MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Onset of sensory and motor block

研究概览

简要总结

Subarachnoid block is used in lower abdominal and lower limb surgeries for post operative pain relief. Opiod drugs have been used along with Bupivacaine and other local anaesthetics in subarachnoid block for prolongation of effect of analgesia and to minimise the requirement of postoperative analgesia

Bupivacaine is an amino amide anesthetic binds to intracellular portion of voltage gated sodium channels and blocks sodium influx into nerves cells which prevent depolarisation so no initiation or conduction of pain signal occur

Buprenorphine is derivative of opiod alkaloid thebaine , provide good intraoperative and postoperartive analgesia. Nalbuphine is highly lipid soluble kappa receptor agonist and mu receptor anatagonist

The Rationale of study is that which among Nalbuphine and Buprenorphine is better adjuvant yet to be explored and only few studies happened in past on it

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor 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

  • American society of Anesthesiologists (ASA) grade 1 or 2 Posted for surgeries of lower abdomen or lower limb of different surgical specialities.

排除标准

  • Patient refusal for procedure Any Neuropathy,Cardiac disease,diabetes,Nephropathy,Coagulopathy Any known allergy to local anaesthetic Patients with contraindications for spinal anaesthesia such as derranged coagulation profile ,raised ICP,local infection at site of needle insertion.

结局指标

主要结局

Onset of sensory and motor block

时间窗: At 2,4,6,8,10,12,14,16,18,20,30,40,50,60,90,120,180,240,360,720 minutes after block , heart rate ,ECG lead 2 ,systolic , diastolic and mean blood pressure and oxygen saturation will be recorded

Duration of sensory and motor block

时间窗: At 2,4,6,8,10,12,14,16,18,20,30,40,50,60,90,120,180,240,360,720 minutes after block , heart rate ,ECG lead 2 ,systolic , diastolic and mean blood pressure and oxygen saturation will be recorded

Duration of postoperative analgesia

时间窗: At 2,4,6,8,10,12,14,16,18,20,30,40,50,60,90,120,180,240,360,720 minutes after block , heart rate ,ECG lead 2 ,systolic , diastolic and mean blood pressure and oxygen saturation will be recorded

次要结局

  • Hemodynamic responses to the drug during and after surgery(Any complication or side effects)

研究者

发起方
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL
申办方类型
Private medical college

研究点 (1)

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