Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy: Prospective Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- NRS score at 24 hours postoperatively
研究概览
简要总结
Nephrectomy is a surgical procedure of choice for patients suffering from renal cell carcinoma (RCC). Even though the laparoscopic approach is considered to cause fewer complications and reduce hospital stay, open surgery is still often performed. Open nephrectomy causes significant acute postoperative pain, and it can also lead to the development of chronic postoperative pain. Pain management is important for the overall recovery of patients undergoing major surgery such as open nephrectomy and it is a part of the enhanced recovery after surgery (ERAS) program.
In this prospective randomized clinical study, we plan to compare two different approaches to pain management regarding the level of acute pain (first 72 hours), side effects, systemic analgesics consumption, and hospital stay.
Our hypothesis are that intrathecal opioid administration significantly reduces acute postoperative pain compared to epidural analgesia in patients undergoing open radical or partial nephrectomy. We also hypothesize that the intrathecal opioid administration is associated with a lower incidence of adverse effects compared to epidural analgesia and shorter ICU length of stay.
详细描述
This is a prospective, single-center, randomized controlled trial. The study will take place in the University Hospital of Split, Departments of Anesthesiology, Reanimatology and Intensive Care Medicine, and the Department of Urology.
Patients undergoing open radical or partial nephrectomy for renal cancer will be randomized to one of the two groups: Epidural analgesia (Control) or intrathecal opioid (Intervention) group. Physiologic functions (blood pressure, heart rate, peripheral oxygen saturation) will be monitored during and after the surgery. Postoperatively, pain scores at rest as well as during movement will be recorded. A total dose of intraoperative opioids, time to first rescue analgesic, and total dose of rescue analgesics as well as adverse effects during the first 72 hours postoperatively will be recorded. These parameters will be compared between the two groups.
Data sources:
Patient records (electronic and paper), direct measurements of patients' physiologic functions (perioperatively, during first 72 hours postoperatively), pain assessment at rest, and movement (Numerical rating scale (NRS)).
Ways of collection of data:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be randomly divided into two groups in a 1:1 ratio. Randomization will be performed using a computer program. A research coordinator will be designated to distribute and preserve randomization results. A person designated for data analysis will be blinded for intervention performed in each group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over the age of 18, scheduled for an open radical or partial nephrectomy due to RCC.
- •American Society of Anesthesiologists (ASA) physical status classification I-III.
排除标准
- •Patients who refuse to participate in this study.
- •Patients with BMI > 35 kg/m2 or < 15 kg/m
- •Patients with renal dysfunction (eGFR <15 or requirement of renal replacement therapy), liver dysfunction (Child-Pugh class C), and heart failure (NYHA IV).
- •Patients with ASA physical status classification ≥ IV.
- •Patients with contraindication for the interventions planned for in this study (allergies to anesthetic drugs used in this study, coagulation disorders, and infection at the injection site).
- •Patients with chronic opioid dependence.
- •Patients unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder.
- •Patients for whom it is impossible to carry out the aforementioned interventions for technical reasons.
结局指标
主要结局
NRS score at 24 hours postoperatively
时间窗: 24 hours
The primary outcome is the difference in NRS score at 24 hours postoperatively at rest and movement. Numeric rating scale (NRS) will be used, ranging from 0-10, where 0 means no pain and 10 means most severe pain.
次要结局
- Intraoperative opioid consumption(Intraoperatively.)
- Numeric rating scale (NRS) score at 1, 3, 6, 48 and 72 hours postoperatively(72 hours.)
- Time to first rescue analgesia postoperatively(In the first 72 hours postoperatively.)
- Total amount of rescue analgesia during 24 and 72 hours postoperatively(72 hours.)
- Incidence of adverse effects(72 hours.)
- Duration of procedure performance(During procedure execution (epidural catether placement, intrathecal administration of the drug).)
- Gastrointestinal function recovery(Up to 72 hours post operatively.)
- Hospital length of stay(Through study completion, an average of 1 year.)
- ICU length of stay(Through study completion, an average of 1 year.)
研究者
Lenko Saric
Assistant professor
University Hospital of Split