A prospective study to compare epidural nalbuphine versus epidural tramadol as an adjuvant to 0.2 percentage ropivacaine for post operative analgesia in lower limb orthopaedic surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- This observational study will help us to know between epidural nalbuphine and epidural tramadol which as adjuvant to 0.2% ropivacaine provides better postoperative analgesia
研究概览
简要总结
This prospective, randomized observational study aims to compare the postoperative analgesic efficacy of epidural buprenorphine and epidural tramadol in lower limb orthopedic replacement surgeries. Conducted at Dhiraj Hospital, Vadodara, the study involves 60 patients aged 18–60 years, classified as ASA Grade I or II, undergoing elective lower limb orthopedic replacement surgeries under spinal anesthesia. Participants are randomly divided into two groups: Group N (receiving epidurally 0.5% ropivacaine 9ml with nalbuphine 10mg) and Group T (receiving epidurally 0.5% ropivacine 9ml with 50 mg tramadol), both diluted with normal saline to a total volume of 10 ml.
The study evaluates the onset, duration, and quality of analgesia, as well as hemodynamic changes between the groups. Exclusion criteria include ASA Grade III or higher, pregnancy, allergies to study drugs, vertebral anomalies, and contraindications to epidural anesthesia. Informed consent is obtained from all participants.
The procedure is administered by an anesthesiologist unrelated to the study, ensuring unbiased results. The findings are expected to determine which drug offers superior postoperative analgesia with fewer side effects, providing valuable insights for optimizing pain management in patients undergoing such surgeries. This research seeks to enhance clinical outcomes and patient comfort in postoperative care.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to sign the written informed consent.
- •Patients belonging to American Society of Anaesthesiologists (ASA) Grade I or II.
- •Male or female patients between age 18-60 years.
- •Patients undergoing elective lower limb orthopedic surgeries under spinal anesthesia.
排除标准
- •Patients unwilling to participate in the study.
- •Patients belonging to ASA Grade III or more.
- •Pregnant or lactating woman.
- •History of known allergy to study drug.
- •Patients having any vertebral anomalies.
- •Patients who needs supplementation of general anaesthesia.
- •Any contraindication to Epidural Anaesthesia (local site infection, coagulation disorder, raised intacranial pressure, hemodynamic instability, neurological disorders,).
- •Children less than 18 years 9) Adults more than 60 years.
结局指标
主要结局
This observational study will help us to know between epidural nalbuphine and epidural tramadol which as adjuvant to 0.2% ropivacaine provides better postoperative analgesia
时间窗: postoperatively,the study drug will be administered via epidural route when VAS more than equal to 4. | * The VAS before administration of drug is considered as "Base Line". | * VAS is noted immediately after administration of drug | * VAS is noted at 1st, 2nd, 3rd, 4th and so on till 10th hour after the administration of the drug via epidural route.
with minimal side effects in patients undergoing lower limb orthopaedic surgeries.
时间窗: postoperatively,the study drug will be administered via epidural route when VAS more than equal to 4. | * The VAS before administration of drug is considered as "Base Line". | * VAS is noted immediately after administration of drug | * VAS is noted at 1st, 2nd, 3rd, 4th and so on till 10th hour after the administration of the drug via epidural route.
次要结局
- to compare the hemodynamics of the two groups(Blood Pressure, Pulse rate & Oxygen Saturation will be measured)
研究者
Akashi Shah
Smt.Bhikiben Kanjibhai Shah Medical Institute and research centre