AN OBSERVATIONAL STUDY TO EVALUATE ONSET OF SENSORY AND MOTOR BLOCKADE AND DURATION OF SENSORY AND MOTOR BLOCKADE WITH HYPERBARIC ROPIVACAINE(0.75%) WITH BUPRENORPHINE AS AN ADJUVANTS FOR LOWER ABDOMINAL SURGERIES UNDER SPINAL ANAESTHESIA
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To assess the sensory and motor onset and duration of sensory and motor blockade of hyperbaric ropivacaine with buprenorphine in lower abdominal surgeries under spinal anaesthesia
研究概览
简要总结
After obtaining ethical committee approval and obtaining written and informed consent, patients of ASA I to ASA III who are undergoing elective lower abdominal surgeries such as abdominal hysterectomy, vaginal hysterectomy, open inguinal hernia repair ,open appendisectomy ,TURP etc. under spinal anaesthesia will be recruited to participate in this observational study.
Pre anesthetic check up will be done in all patients with detailed history, general and systemic examination and investigations. After checking the adequate hours of nil by mouth, arrival to the pre-operative room heart rate, respiratory rate, blood pressure and spo2 will be recorded in all patients, an intravenous line will be checked and patients will be preloaded with iv fluids half an hour before anaesthesia.
The patients will be placed in sitting/lateral position, under all aseptic precautions skin and subcutaneous tissue will be infiltered with 2ml of 2% lignocaine. 23 G Quincke’s spinal needle will be inserted. After confirmation of needle tip in the subarachnoid space by free flow of cerebrospinal fluid, spinal anaesthesia will be given with hyperbaric ropivacaine (0.75%) 3 ML with buprenorphine 150mcg in L2-L3/L3-L4 space through a midline/paramedian approach. Our goal will to achieve the level of block at T8 level. After injection, patients will be placed in supine position immediately. Sensory effect will be assessed by pin prick method and motor effect will be assessed by modified bromage scale (grade 0- no loss of motor power to grade 4- complete paralysis).
Using a preformed structured proforma the following parameters will be recorded: onset of sensory blockade, onset of motor blockade (Bromage scale 1), maximum dermatomal level of sensory blockade attained and the time to achieve it, maximum grade of motor blockade attained and the time to achieve it, total duration of analgesia and the duration of motor blockade (regression to bromage 0). Other parameters such as total duration of surgery, total intraoperative fluid given, hemodynamic monitoring till the full recovery of sensory and motor blockade will be noted. Patients will be also monitored for any adverse effects like bradycardia, hypotension, nausea, vomiting, headache, pruritus, urinary retention and any hypersensitivity reactions to drug.[4]
In Post anaesthesia care unit, patients will be monitored for 30 minutes and then transferred to ward. Iv fluid for 6 hours will be given. Post operative pain will be recorded at 6,12 and 24 hours after surgery using visual analogue score
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with physical status of ASA(American society of Anaesthesiologists) ASA I to ASA III, Patients undergoing above mentioned lower abdominal surgeries.
排除标准
- •Patients refusal to spinal anaesthesia, Infection at site of spinal needle insertion, Patients having allergy to local anesthetic drug or drug used in the study, Coagulopathy or bleeding disorder, Increased intracranial pressure, Patients having instrumentation at the site of spinal needle insertion.
结局指标
主要结局
To assess the sensory and motor onset and duration of sensory and motor blockade of hyperbaric ropivacaine with buprenorphine in lower abdominal surgeries under spinal anaesthesia
时间窗: 0 minutes, 10 minutes
次要结局
- To observe post operative time of rescue analgesia, time of first micturition and time of mobilisation after hyperbaric Ropivacaine with Buprenorphine in lower abdominal surgeries under spinal anaesthesia(From the time of completion of surgery till 24 hours)
研究者
Dr Vaibhavi Hajariwala
Shree Krishna Hospital, Pramukh Swami Medical College
