跳至主要内容
临床试验/CTRI/2019/11/022185
CTRI/2019/11/022185招募中1 期

Comparing the efficacy of magnesium sulphate as an adjuvant to fentanyl and ketamine in patient controlled analgesia for post operative pain management ,in patients undergoing multilevel posterior spinal fusion-A double blinded randomised controlled study.

christian medical college vellore1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年1月12日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
35
试验地点
1
主要终点
post operative pain score at rest and on movement.

研究概览

简要总结

Management of post operative pain is challenging. Posterior spine fusion surgeries require high quality analgesia to maximize functional recovery . Adequate post-operative analgesia helps with early mobilisation, brief hospital stay, reduced hospital costs and increased patient comfort. Magnesium sulphate through NMDA receptor blockade in the central nervous system and calcium channel blockade has been reported to be an effective anesthetic adjunct for pain relief and also in blunting somatic , autonomic and endocrine reflexes induced by noxious stimuli. Magnesium sulphate has been used in the form of bolus and /or continuous intravenous infusions intra-operatively and has been found to attenuate acute post-operative pain in total knee arthroplasty. In this randomized control trial , we aim to assess the efficacy of magnesium sulphate as an additive in intravenous patient controlled analgesia (PCA) for post operative pain management ,in patients undergoing multilevel posterior spinal surgeries between the age of 18-65 years. The participants are randomized into two study groups - group 1 receiving PCA fentanyl and ketamine and group 2 receiving PCA fentanyl ,ketamine and magnesium .Postoperatively the pain scores will be assessed at specified time intervals as specified in the attached sheet. Vitals , sedation score ,nausea ,vomiting and quality of sleep will be monitored regularly in the ward. Number of boluses delivered to each participant will be noted 24 hours after surgery .Serum magnesium levels will be checked pre operatively and at 24 ,48 hours after starting the PCA infusion . Magnesium toxicity will be monitored by regular assessment of knee jerk, urine output and respiratory rate. Participants will be followed up at 3 months of surgery for the assessment of chronic pain relief.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator 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

  • 1.patients undergoing multilevel posterior spinal fusion 2.ASA I and II 3.Age between 18-65 years 4.GFR (glomerular filtration rate ) >90ml/min/1.73m2.

排除标准

  • ASA III and IV
  • GFR <90ml/min/1.73m2
  • Patients diagnosed with hypermagnesemia
  • Chronic opioid use
  • Allergy to study drugs
  • Inability to use PCA pumps.

结局指标

主要结局

post operative pain score at rest and on movement.

时间窗: post operative pain score at rest and on movement at 0,6,12,24,36 and 48 hours.

次要结局

  • number of boluses administered at end of 24 hours,assessment of quality of sleep,post operative nausea and vomiting,sedation scores,chronic pain assessment.(0,6,12,24,36,48 hours and 3 months)

研究者

发起方
christian medical college vellore
申办方类型
Research institution and hospital

研究点 (1)

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