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临床试验/CTRI/2024/06/068792
CTRI/2024/06/068792尚未招募1 期

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

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月24日最近更新:

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

发起方
Department of Anaesthesiology
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vaibhavi Hajariwala

Shree Krishna Hospital, Pramukh Swami Medical College

研究点 (1)

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