跳至主要内容
临床试验/CTRI/2024/08/073149
CTRI/2024/08/073149尚未招募不适用

Dose response of Intravenous Dexamethasone on post operative pain with Subarachnoid block in Lower limb Osteoarticular surgery

school of medical sciences and research1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年9月12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
75
试验地点
1
主要终点
To evaluate and compare the duration of analgesia with two different doses of IV Dexamethasone supplemented after subarachnoid block given with hyperbaric Bupivacaine in lower limb osteoarticular surgery.

研究概览

简要总结

Acute postoperative pain causes patient discomfort and also impedes the recovery.  Regional blocks with long-acting local anaesthetics are helpful to achieve surgical anaesthesia and longer duration of post operative analgesia. Spinal anaesthesia is widely used in lower abdominal surgeries, as it plays a crucial role in relieving postoperative pain and enabling ambulatory anaesthesia1. It is safe, cost effective and easy to perform technique, which provides a denser block and so more preferred2.

Multimodal analgesia is method of pain management in which combined medication groups include (local anaesthetics, opioids, NSAIDS, acetaminophen and alpha-2 agonists, gabapentinoids, dexamethasone) are used for pain relief.

It has been found that many drugs, such as opioids (morphine, fentanyl, and sufentanil), α2 adrenergic agonists (dexmedetomidine and clonidine), magnesium sulphate, neostigmine, ketamine, and midazolam, can be used as adjuvants for intrathecal local anaesthetics to improve the quality of spinal anaesthesia and post-operative pain3.

Dexamethasone is a potent long acting glucocorticoid with plasma half-life of 36 hrs having minimal mineralocorticoid activity, with anti-inflammatory and analgesic property. It is regarded as one of the ideal perioperative drugs being readily available, cheap, suppresses inflammation, prevent and treats postoperative nausea and vomiting, promotes appetite and provide good analgesia, when given intravenously and as an adjunct to peripheral nerve blocks. It provides good quality of recovery and early discharge of patients.

It acts on hypothalamic pituitary adrenal axis to produce its effect. Systemic administration of dexamethasone has been found to possess anti-inflammatory and immunosuppressive properties, which may contribute to prolonged analgesia when administered intravenously4.

Various studies suggest that intravenous dexamethasone as an adjunct with local anaesthetic prolongs the duration of spinal anaesthesia and also provides post-operative analgesia

IV administration of dexamethasone improves postoperative VAS score and decreases   overall postoperative analgesic consumption in patients given subarachnoid block with hyperbaric bupivacaine5. Higher dose of dexamethasone is superior to lower dose, although both prolongs analgesia and were effective in reducing postoperative opioid consumption.

Various studies show that duration of sensory and motor block was significantly higher in patient receiving higher dose of intravenous dexamethasone as compared to lower dose5,6

Lacunae in existing knowledge

However, to the best of our knowledge and also after searching quite a number of articles and extensive literature search, it has been found that no previous studies have compared the analgesic effect of two doses of intravenous dexamethasone, (0.15 mg/kg and 0.075 mg/kg) supplemented after subarachnoid block given with hyperbaric Bupivacaine in lower limb osteoarticular surgery. Therefore, we will compare the effects of two different doses of intravenous dexamethasone on postoperative pain in patients given subarachnoid block with 0.5% hyperbaric bupivacaine.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Patients scheduled for lower limb osteoarticular surgery under subarachnoid block.
  • ASA grade I.
  • Age 18- 60 yrs.
  • Height 150-170 cm.
  • BMI less than kg per metre square.
  • Both genders.

排除标准

  • 1.History of allergy to local anaesthetic.
  • 2.History of chronic use of corticosteroids, opioids and any other analgesics.
  • 3.Pregnant females.
  • 4.History of endocrine disease- Diabetes mellitus and thyroid disease 5.History of CNS, cardiovascular and renal disease.
  • 6.Presence of active infection in the body.

结局指标

主要结局

To evaluate and compare the duration of analgesia with two different doses of IV Dexamethasone supplemented after subarachnoid block given with hyperbaric Bupivacaine in lower limb osteoarticular surgery.

时间窗: 24 hrs

次要结局

  • To evaluate and compare the effect on with regards to:((a)VAS score)

研究者

发起方
school of medical sciences and research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr SONAM

school of medical sciences and research, Sharda Hospital

研究点 (1)

Loading locations...

相似试验