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临床试验/CTRI/2026/01/102084
CTRI/2026/01/102084尚未招募不适用

The effect of intravenous dexamethasone on postoperative pain management in patients undergoing unilateral total knee arthroplasty under subarachnoid block

Dr Prem Nair1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月17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
Decreased analgesic requirements as assessed by perioperative opioid consumption

研究概览

简要总结

Patients will be randomly allocated to either of the two groups [ Group D or Group P] using computer generated random sequence of numbering. Concealment of allocation will be ensured by sequentially numbered opaque sealed envelopes.                                         On the day of surgery, patients in Group D will receive 0.1mg/kg Dexamethasone (rounded up to the nearest milligram dose) diluted up to 5 ml with normal saline before performance of spinal anaesthesia, whereas Group P will receive 5ml of normal saline. The drug will be administered by the posted anaesthetist in the OR immediately following establishment of IV access. All standard monitors will be attached and baseline HR, SBP, MAP will be recorded. Blood sugars will be checked using GRBS before administration of spinal anaesthesia and at 2 hourly intervals intraoperatively. All patients will receive spinal anaesthesia with bupivacaine 0.5%(H) 3ml + fentanyl 25mcg (0.5ml). After confirming adequate blockade, patient will be positioned for surgery. At the end of surgery under aseptic precautions and USG guidance adductor canal block will be given with ropivacaine 0.2% 20 ml and catheter placed. Post operatively Group D will receive another dose of dexamethasone 0.1mg/kg (rounded upto the nearest milligram dose) diluted up to 5 ml, 8 hours after the initial dose whereas group P will receive 5ml of normal saline. The study drug as well as placebo will be loaded in a 5ml unlabelled syringe (by the operating room anaesthetist) labelled as study drug and administered by the ICU anaesthetist. Both the ICU anaesthetist and the staff nurse will be blinded to the study group. All patients will receive IV paracetamol 1-gram IV TID along with buprenorphine patch 10mg.

Patients will receive IV fentanyl or morphine as rescue analgesic as decided by the duty anaesthetist to keep the VAS score below 4. The cumulative opioid consumption for each patient for the first 48 hours after surgery will be recorded as morphine equivalents.

Other perioperative complications documented will be –

Post operative Nausea and vomiting using simplified PONV impact scale.

Significant PONV will be managed by IV ondansetron 0.1mg/kg Q8h

Incidence of post operative pruritus and hyperglycaemia (sugars more than 180 mg% on two consecutive occasions post-operatively)

Hyperglycaemia postoperatively will be managed with delta protocol insulin infusions as routinely prescribed along with previously prescribed oral hypoglycaemics as directed by the ICU anaesthetist.

Wound issues (healing / as assessed by the surgical team at discharge will also be documented.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing elective unilateral primary total knee arthroplasty.

排除标准

  • Patients less than 18 years of age or more than 90 years of age uncontrolled diabetics.

结局指标

主要结局

Decreased analgesic requirements as assessed by perioperative opioid consumption

时间窗: Decreased analgesic requirements as assessed by perioperative opioid consumption over the first 48 hours following surgery

次要结局

  • Post-opertive nausea and vomiting(Assessed at 48 hours postoperatively)

研究者

发起方
Dr Prem Nair
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Mathew George

Amrita Institute of Medical Sciences and Research Center,Kochi

研究点 (1)

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