COMPARISON ON EFFICACY OF INTRATHECAL 0.5 PERCENT HYPERBARIC BUPIVACAINE VERSUS 0.5 PERCENT HYPERBARIC LEVOBUPIVACAINE WITH ADDITIVE BUPRENORPHINE 100mcg IN BOTH FOR ORTHOPAEDIC LOWER LIMB SURGERY : A RANDOMIZED CLINICAL STUDY
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ONSET OF SENSORY BLOCK
研究概览
简要总结
In my study when we compared intrathecal 0.5 percent hyperbaric bupivacaine versus 0.5 percent hyperbaric levobupivacaine with additive buprenorphine 100mcg for lower limb orthopedic surgery.We found levobupivacaine gave better hemodynamic stability, extended time for first rescue analgesia, improved post operative pain score and reduced requirement of additional analgesics while bupivacaine is comparable with levobupivacaine it provides prolonged duration of motor blockade which may delay early ambulation
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adult patients aged 18 to 60 years of either sex.2 Patients scheduled for elective orthopedic lower limb surgeries under subarachnoid block.
- •3 Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
- •4 Patients who are willing to participate in the study and provide voluntary written informed consent prior to enrollment.
排除标准
- •1 Patients with a known history of hypersensitivity or allergy to local anesthetic agents or opioids.
- •2 Patients with absolute contraindications to spinal anesthesia, including but not limited to raised intracranial pressure, severe hypovolemia, bleeding diathesis, coagulopathy, infection at the injection site, pre-existing neurological deficits, or significant spinal deformities.
- •3 Patients with neurological or psychiatric disorders, or those with communication difficulties that may interfere with accurate assessment of sensory block, motor block, or pain scores.
- •4 Patients classified as ASA physical status III, IV, or V, due to increased perioperative risk and potential confounding of outcomes.
- •5 Patients aged below 18 years or above 60 years, to maintain homogeneity of the study population and minimize age-related physiological variability.
结局指标
主要结局
ONSET OF SENSORY BLOCK
时间窗: 2MINUTES | 4MINUTES | 6MINUTES | 8MINUTES | 10MINUTES | 15MINUTES | 20MINUTES | 25MINUTES | 30MINUTES | 60MINUTES | 90MINUTES | 120MINUTES | 150MINUTES | 180MINUTES
TIME TO ACHIEVE MAXIMUM SENSORY BLOCK
时间窗: 2MINUTES | 4MINUTES | 6MINUTES | 8MINUTES | 10MINUTES | 15MINUTES | 20MINUTES | 25MINUTES | 30MINUTES | 60MINUTES | 90MINUTES | 120MINUTES | 150MINUTES | 180MINUTES
TWO SEGMENT SENSORY REGRESSION TIME
时间窗: 2MINUTES | 4MINUTES | 6MINUTES | 8MINUTES | 10MINUTES | 15MINUTES | 20MINUTES | 25MINUTES | 30MINUTES | 60MINUTES | 90MINUTES | 120MINUTES | 150MINUTES | 180MINUTES
DURATION OF SENSORY BLOCK
时间窗: 2MINUTES | 4MINUTES | 6MINUTES | 8MINUTES | 10MINUTES | 15MINUTES | 20MINUTES | 25MINUTES | 30MINUTES | 60MINUTES | 90MINUTES | 120MINUTES | 150MINUTES | 180MINUTES
ONSET AND DURATION OF MOTOR BLOCK
时间窗: 2MINUTES | 4MINUTES | 6MINUTES | 8MINUTES | 10MINUTES | 15MINUTES | 20MINUTES | 25MINUTES | 30MINUTES | 60MINUTES | 90MINUTES | 120MINUTES | 150MINUTES | 180MINUTES
TOTAL DURATION OF ANALGESIA
时间窗: 2MINUTES | 4MINUTES | 6MINUTES | 8MINUTES | 10MINUTES | 15MINUTES | 20MINUTES | 25MINUTES | 30MINUTES | 60MINUTES | 90MINUTES | 120MINUTES | 150MINUTES | 180MINUTES
次要结局
- HEMODYNAMIC MONITORING - HEART RATE BLODD PRESSURE AND ADVERSE EVENTS(2 MINUTE)
- TIME TAKEN FOR 2 SEGMENT REGRESSION , TOTAL DURATION OF SENSORY AND MOTAL BLOCKADE , POST OP HEMODYNAMIC STABILITY , TIME TAKEN FOR FIRST ANAGESIA(2 HOURS)
研究者
DR ASHA MALLINATH INDUR
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE