Comparison of Ultrasound Guided Interscalene Brachial Plexus Block with 6ml and 10ml of 0.25 percent Ropivacaine for post operative analgesia in elective upper limb orthopaedic surgeries: A Randomised Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare post operative analgesia between 6 ml of 0.25% Ropivacaine
研究概览
简要总结
In the field of Anaesthesia, regional blocks are growing popular these
days because of prolonged duration of action and lesser perioperative
analgesic requirement.
• Interscalene brachial plexus block is frequently used to provide
perioperative analgesia to patients undergoing upper limb surgeries to
optimise recovery, decrease opioid consumption and reduce the
hospital stay.
• Ropivacaine is a long-acting amide local anaesthetic agent that is
structurally related to Bupivacaine.
• It is a pure S(-)enantiomer, unlike Bupivacaine, which is a racemate,
developed for the purpose of reducing potential toxicity and improving
relative sensory and motor block profiles .
• Ropivacaine in interscalene brachial plexus block provides safe and
effective pain relief , decreased incidence of side effects and better
patient satisfaction than with opioids given intravenously.
• The use of a local anaesthetic with a lower concentration and volume
results in fewer instances of side effects brought on by local anaesthetic
drugs.
• Furthermore, use of ultrasound in peripheral nerve block has reduced
the amount of Local Anaesthetic.
• Studies have been found with 0.5% or 0.75% of 15ml Ropivacaine used
for peripheral blocks which provide same analgesia with less side effects
of Ropivacaine .
• Interscalene brachial plexus block is generally performed on patients
undergoing shoulder, upper arm and elbow surgeries .
• One of the side effects of this block is Hemidiaphragmatic paresis.
• Studies were found where small volume of local anaesthetic for
interscalene brachial plexus block helped in reducing the incidence of
hemidiaphragmatic paresis.
• Therefore, our aim is to compare 6ml and 10ml of 0.25% Ropivacaine in
ultrasound guided interscalene block in upper limb surgeries with
respect to postoperative analgesia and side effects like
hemidiaphragmatic paresis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients posted for upper limb orthopaedic surgeries 2.Patients in ASA criteria 1,2 3.Patients with BMI less than 30 kg/m2.
排除标准
- •History of allergy to study drug
- •Patient with coagulation disorders
- •Infection at site of block
- •Severe bronchopulmonary disease
- •Neurological deficit in the operating arm 6.
结局指标
主要结局
To compare post operative analgesia between 6 ml of 0.25% Ropivacaine
时间窗: 1. Total analgesic dose required in 24 hours after block. | 2. Numerical rating scale (NRS) for pain assessment at 0.5, 1, 1.5, 2, 4, 6, 12, 24 hrs after block in first 24 hours. | 3. Time for requirement for first rescue analgesia after block in first 24 hours.
vs 10 ml of 0.25% Ropivacaine in ultrasound (USG) guided Interscalene
时间窗: 1. Total analgesic dose required in 24 hours after block. | 2. Numerical rating scale (NRS) for pain assessment at 0.5, 1, 1.5, 2, 4, 6, 12, 24 hrs after block in first 24 hours. | 3. Time for requirement for first rescue analgesia after block in first 24 hours.
brachial plexus block for Elective Upper Limb Orthopedic surgeries
时间窗: 1. Total analgesic dose required in 24 hours after block. | 2. Numerical rating scale (NRS) for pain assessment at 0.5, 1, 1.5, 2, 4, 6, 12, 24 hrs after block in first 24 hours. | 3. Time for requirement for first rescue analgesia after block in first 24 hours.
次要结局
- To compare side effects of 0.25 percent Ropivacaine 6 ml & 0.25 percent(Ropivacaine 10 ml in Ultrasound guided Interscalene Block for Upper)
研究者
Gayatri Awatade
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital