A comparative study of epidural 0.125 percent Bupivacaine infusion versus combination of epidural Bupivacaine 0.125 percent with 2 mcg per ml Fentanyl infusion for post operative pain relief in abdominal surgeries under general anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To Compare the post operative analgesic effect after administration of epidural bupivacaine 0.125% infusion and combination of epidural bupivacaine 0.125% with 2 mcg/ml fentanyl infusion
研究概览
简要总结
The Study “A Comparative study of Epidural 0.125% Bupivacaine infusion V/S Combination of Epidural Bupivacaine 0.125% with 2 mcg/ml Fentanyl Infusion for Post operative Pain relief in abdominal surgeries under General anaesthesia" will be conducted in Department of Anesthesia ,Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh 242307
A. The study will be conducted on subjects undergoing Abdominal Surgeries presenting to PAC Room in Department of Anesthesia ,Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur based on Inclusion and Exclusion criterias
B. All patients selected for the study will undergo datailed history taking and written informed consent
C. PAC assessment
D. Laboratory assessment
E. Patients will be admitted one day before the surgery
F. Patients will be allocated randomly into 2 groups
Group B : Patients in this group will receive a 0.125% Bupivacaine infusion in the post-operative recovery room
Group BF : Patients in this group will receive a 0.125% Bupivacaine + 2 mcg/ml Fentanyl infusion infusion in the post-operative recovery room
G. Patient Monitoring : SBP, DBP, HR and VAS SCORE recorded at specified intervals after starting epidural infusion for the first 24 hours
H. Adverse Events : Any adverse events , such as hypotension, nausea , vomiting and motor blockade and other side effects will be recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists ASA grade I and II Patients who gave written informed consent Patients who are suitable for epidural analgesia based on preoperative assessment including coagulation profile evaluation and absence of contraindications to regional anaesthesia techniques Patients who are able to communicate effectively and provide reliable feedback regarding pain intensity and any adverse effects experienced during the study period Weight :
- •70 kg, Height :
- •180 cm, BMI : 20.
排除标准
- •Patients younger than 18 years old.
- •Patient not willing .
- •Infection at the site of block.
- •Patients with known allergy to local anaesthetics (such as bupivacaine) or opioids (such as fentanyl), or those with a history of adverse reactions to these medications.
- •Patients with coagulation disorders or those receiving anticoagulant therapy.
- •Patients with abnormal psychological profile on drugs like antileptic & other drugs acting on CNS .
- •Patient with pre-existing neurological disorders (e.g., neuropathy, myopathy) that may affect the assessment of pain or increase the risk of neurological complications related to epidural analgesia.
- •Patients who are unable to provide informed consent Patient who take analgesics for last 48 hours.
- •Patient having chronic pain at the site of injection Base line blood pressure less than 100/60 mmHg.
结局指标
主要结局
To Compare the post operative analgesic effect after administration of epidural bupivacaine 0.125% infusion and combination of epidural bupivacaine 0.125% with 2 mcg/ml fentanyl infusion
时间窗: From starting of infusion till 24 hours
次要结局
- To Determine the requirement for rescue analgesia postoperatively when patient is on Epidural infusion(From starting of infusion till 24 hours)
研究者
Dr Paran Gupta
Varun arjun medical college and rohilkhand hospital