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临床试验/CTRI/2019/12/022513
CTRI/2019/12/022513已完成不适用

Epidural morphine and ketamine versus intravenous morphine and ketamine on postoperative quality of recovery(QoR) in patients undergoing transforaminal lumbar interbody fusion:A single blinded randomised controlled trial.

Institutional Review Board1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月24日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
To compare the Quality of recovery score between the two groups of patients using QoR 15 Score.

研究概览

简要总结

Pain is an important factor affecting postoperative quality of recovery (QoR) after open transforaminal lumbar interbody fusion (TLIF) surgery. It not only delays discharge from hospital but also affects the patient’s physical and psychological recovery. Continuous administration of intravenous morphine with or without ketamine is routinely used to treat postoperative pain after major spine surgery at our institution. Continuous administration

of I.V morphine at fixed rate can lead to either overdose or under dose. So we have decided to administer i.v morphine through patient control analgesia system, where patient can control their pain by themselves by administering morphine and ketamine using a pump.

Epidural morphine has been shown to decrease postoperative pain and opioid consumption after spine surgery and when coupled with the simultaneous administration of Ketamine, a further decrease in the total opioid dose and side effects may be expected. In this study we wish to compare two routes of administration of these drugs for providing postoperative analgesia in patients undergoing open TLIF. Our hypothesis is that the epidural administration of morphine and ketamine would be superior to intravenous administration of these drugs. Forty ASA 1 and 2 patients will be randomized into two groups after obtaining informed consent. Patients with age > 70 years, ASA 3 and 4, BMI > 30, Obstructive sleep apnoea, impaired renal function (serum creatinine > 1.4mg/dl), moderate to severe chronic obstructive lung disease, H/o previous surgical procedures in the lumbosacral region, H/o psychiatric illness all will be excluded. Group A will receive epidural morphine and ketamine (Inj. Morphine 8 mg, ketamine 60 mg diluted with normal saline, total volume made to 50 ml ,injected through the epidural catheter at 1 ml/hour, while patients in Group B will receive the same drugs intravenously at the concentration ratio of 1:1 via the CADD pump. Group B patients will get 0.015 ml/kg/bolus with the lockout period of 10 mins (max up to 6 bolus dose/hr) for 48 hours. The intraoperative anaesthetic techniques in the two groups will be standardised. Patients will be assessed at specified times after surgery with regard to verbal rating scale (VRS) for pain and for the side effects like postoperative nausea and vomiting, sedation, respiratory depression, hallucination. Patient satisfaction score and quality of recovery score will be assessed at the end of 48 hours

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA grade I and II 2.Patients undergoing Transforaminal Lumbar Interbody fusion.
  • 3.Normal renal function.

排除标准

  • 1.ASA III and IV 2.BMI >30
  • Impaired renal function.
  • 4.Intraoperative csf leak 5.Previous surgical procedures in lumbo sacral region 6.Patients with psychiatric illness.
  • 7.Obstructive sleep apnoea.

结局指标

主要结局

To compare the Quality of recovery score between the two groups of patients using QoR 15 Score.

时间窗: Primary investigator will assess the Quality of recovery at the end of 48 hours after operation in the ward.

次要结局

  • 1. To compare the analgesic efficacy of the two techniques using Numeric rating scale at movement.(2.Patient satisfaction score (0-10).)

研究者

申办方类型
Private medical college

研究点 (1)

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