To compare the opioid sparing effects of combination of Gabapentin, Dexamethasone, Paracetamol and ketorolac (GaDexPaK) vs Dexamethasone, Paracetamol and Ketorolac (DexPaK) in patients undergoing Modified Radical Mastectomy: A Prospective Double Blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Total Intravenous Patient Controlled Analgesia (PCA) fentanyl consumption in the first 24 hours postoperatively.
研究概览
简要总结
Modified radical mastectomy attributed for 31% of all breast surgeries and is preferred over other surgeries because of its cosmetic and functional supremacy. Regardless of being the commonly done surgery, one of the terrible complications of MRM is acute Intraoperative and postoperative pain due to the handling of substantial amount of breast tissue, axillary lymph nodes and intercostal nerves.
Opioids are one of the most commonly used medications but they are accompanied with a wide range of side effects like nausea, vomiting, constipation, excessive sedation, clouded sensorium, dizziness, respiratory depression, and addiction.
Hence a practice of multimodal analgesia using primarily acetaminophen, non-selective NSAIDS, selective COX-2 (cyclooygenase) NSAIDS, steroids , GABA agonist[gabapentin] is used. Our study is designed to compare the analgesic efficacy and effect on opioid sparing effect of Gabapentin, Dexamethasone, Paracetamol and ketorolac combination with Dexamethsone, Paracetamol and Ketorolac combination in patients undergoing modified radical mastectomy.
All the patients recruited in the study will be divided into 2 groups
Group D - Tab. Gabapentin 600mg orally + Dexamethasone (0.2mg/kg) i.v in 100 ml saline over 15 minutes, 1 hr before surgery and PCM 1g + Ketorolac 30mg I.V before induction
Group C - Placebo tablet(Calcium carbonate 500 mg) orally + Dexamethasone(0.2mg/kg) i.v in 100 ml saline over 15 minutes, 1 hr before surgery and PCM 1g +I.V Ketorolac 30mg before induction
Patients will be assessed for 24 hrs fentanyl consumption in the postoperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients of ASA physical status I and II posted for elective Modified Radical Mastectomy.
排除标准
- •Patient refusal
- •Known allergy to the drug
- •H /O gastric or duodenal ulcer
- •H/O Asthma
- •H/O Diabetes mellitus
- •Pregnancy
- •Chronic analgesic or steroid or opioid consumption
- •Patient who is already on gabapentin or any other antiepileptic drugs or antidepressant or benzodiazepines
- •Impaired kidney and liver function
- •Limitations in understanding use of PCA pump
- •H/O Migraine or Chronic Pain.
结局指标
主要结局
Total Intravenous Patient Controlled Analgesia (PCA) fentanyl consumption in the first 24 hours postoperatively.
时间窗: 24 hours postoperatively.
次要结局
- 1) Time for first analgesic requirement(2) Post operative pain scores at rest & during movement)