A prospective double-blinded randomised controlled study to assess the safety and efficacy of dexamethasone in post-operative multimodal analgesia after minimally invasive esophagectomy at a tertiary care cancer centre
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To calculate the total opioid consumption (in terms of morphine equivalents) in the post operative period
研究概览
简要总结
This is a prospective, double-blinded, phase II randomised controlled trial being done to evaluate the safety and efficacy of dexamethasone as a multimodal analgesic in minimally invasive esophagectomy in esophageal cancer patients . Patients included in the study will be randomised into two groups: one receiving dexamethasone as an adjunct to standard multimodal analgesia, and the other receiving placebo [ normal saline ] with standard care as per Institutional practice. All the patients will be provided with Fentanyl PCA in the post operative period for 48 hours post surgery
The primary outcome will be to calculate the total opioid consumption in the first 48 hours after surgery in terms of morphine equivalents.
Secondary endpoints will include pain scores assessment pre determined time intervals , incidence of postoperative nausea and vomiting, hyperglycemia and safety parameters such as wound healing complications, infections, and anastomotic leak.
The trial will follow Good Clinical Practice guidelines, with appropriate safety monitoring and interim analyses. Findings are expected to clarify whether dexamethasone provides a safe and effective enhancement to multimodal pain management after minimally invasive esophagectomy in a cancer care setting.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 80 years undergoing minimally invasive oesophagectomy (Video Assisted Thoracoscopic Surgery / Robotic).
排除标准
- •Contraindications to Dexamethasone- a) Diabetic patients with HbA1c more than 6, patients requiring insulin therapy b) Patients with evidence of preoperative infection suggested by fever, radiological signs suggestive of infection in the chest, deranged CRP, PCT, WBC more than 11,000 or less than
- •c) Patients on chronic steroid therapy.
- •Chronic therapy with opioids, drug addiction, or a history of drug abuse.
- •Contraindications to diclofenac- a) Deranged Renal function suggested by past history of Acute Kidney Injury / Chronic Kidney Disease, with serum creatinine
- •Contraindications to diclofenac- a) Deranged Renal function suggested by past history of Acute Kidney Injury / Chronic Kidney Disease, with serum creatinine more than 1.5 mg percent and /or requiring dialysis/ Renal replacement Therapy, b) Deranged renal function tests –serum creatinine value more than 1.5mg / dl c) Patients with low platelet counts ( less than 75,000 per microlitre) d) Patients with a history of peptic ulcer disease, e) Patients with pre-existing susceptibility to Aspirin-induced Bronchial asthma.
- •Contraindication to Paracetamol -liver dysfunction- Child – Pugh – Turcotte score of class B (value 7 – 9 ) and above, indicating moderately impaired hepatic function 1.5 mg percent and /or requiring dialysis/ Renal replacement Therapy, b) Deranged renal function tests –serum creatinine value more than 1.5mg / dl c) Patients with low platelet counts ( less than 75,000 per microlitre) d) Patients with a history of peptic ulcer disease, e) Patients with pre-existing susceptibility to Aspirin-induced Bronchial asthma.
- •Contraindication to Paracetamol -liver dysfunction- Child – Pugh – Turcotte score of class B (value 7 – 9 ) and above, indicating moderately impaired hepatic function.
结局指标
主要结局
To calculate the total opioid consumption (in terms of morphine equivalents) in the post operative period
时间窗: First 48 hours after surgery
次要结局
- Numeric Rating Scale (0-10) for pain at rest ( NRS REST), Numeric Rating Scale after exercise ( NRS EXERCISE ), Maximum inspiratory efforts on spirometer at predefined time intervals(1-4 hours, 4-8 hours, 8-12 hours, 20-24 hours, 30-36 hours and 44- 48 hours after the surgery)
- The worst pain NRS(at 24 hours and 48 hours)
- Episodes of hyperglycaemia (blood sugar levels above 180 mg/dl)(up to 48 hours)
- Episodes of post-operative nausea, vomiting(Till 48 hours post surgery)
- Incidence of –
研究者
Dr Swapnil Y Parab
Tata Memorial Hospital