COMPARATIVE EVALUATION OF ANALGESIC EFFECT OF 0.5% ROPIVACAINE WITH OR WITHOUT DEXAMETHASONE FOR POPLITEAL SCIATIC NERVE BLOCK IN PAEDIATRIC ANKLE AND FOOT SURGERIES.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare duration of analgesia by addition of dexamethasone to 0.5%ropivacaine to using 0.5%ropivacaine plain alone for popliteal sciatic nerve block in children undergoing foot and ankle surgeries as assessed by time to first rescue analgesic requirement
研究概览
简要总结
METHODOLOGY:
All patients who meet the inclusion criteria will undergo pre anaesthetic evaluation as per the protocol of the department
A written informed consent from parents will be taken.
All patients will be nil per oral for 6 hours for solid food and 4 hours for clear liquids as per NPO guidelines. Premedication will be given as syrup phenargan0.5mg/kg 30min before surgery
Patient will be shifted to operating room.Standard monitoring like ECG leads, NIBP, Pulseoximeter will be attached and preoperative baseline parameters recorded.
Inhalational induction with sevoflurane and 100%02 will be done, IV line will be secured, Fentanyl citrate 2mcg/kg will be given (over 30 second) and After ensuring check ventilation, vecuronium 0.1mg/kg will be administered intravenously. Patient will be ventilated with mixture of oxygen + N2O(50:50) for 3 min and then laryngeal mask airway of appropriate size will be inserted. After confirming bilateral equal air entry, the laryngeal mask airway will be fixed and normocapnic ventilation will be started with monitoring of vitals.
Under all aseptic precaution cleaning and draping will be done, sterile cover for ultrasound probe.The goal is to inject the local anaesthetic within the common connective tissue(VLOKA’S) sheath that envelops the tibial and common peroneal nerve
The Popliteal fossa has semitendinosus, semimembranosus medially and biceps femoris laterally. Linear transducer of straight array[10to14MHz] oriented in the short axis placed in popliteal fossa.Identify Popliteal artery and vein deeper in the region will be identified,The nerves are lateral and superficial to vessels.
The needle will be approached from lateral to medial with patient in supine position with knee flexed.
LA CHOICE AND DOSAGE:
Dose of ropivacaine:2mg/kg
Dose of dexamethasone:0.1mg/kg
If either HR or BP increased to 20% more than post induction or pre block levels, Fentanyl 0.5-1mcg/kg will be administered and repeated as required.
Patients will be classified as having pain on the basis of tw scoroing systems: OPS[0-6years] and VAS[6-12years].Half an hour before end of surgery patient will receive Inj. Paracetamol 7.5mg/kg for patients <10kg body weight and 15mg/kg for patients >10kg body weight. Reversal will be achieved with inj.neostigmine[50mic/kg] and inj.glycopyrrolate[10mic/kg] prosealLMA removal will be done after return of adequate reflexes.
Postoperatively pain assessment using VAS[6-12YRS] OR OPS[0-6YRS] AT T0,T30min,T1,2,4,6,12,24hrs respectively will be administered for an age appropriate pain score( VAS/OPS depending upon the age group) of between 4 TO 6(0–10) and Inj. Tramadol 1mg/kg intravenously for a score >6 . Before giving Tramadol Inj. Ondansetron 0.1mg/kg administered to prevent vomiting.The same general protocol will be followed in the post operative ward for 24 hour. Time to first resque analgesic requirement will be noted and additional doses of analgesic requirements over 24hrs and side effects like nausea,vomiting etc.will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Asa grade 1and2 of either gender undergoing elective foot and ankle surgeries under GA.
排除标准
- •Infection at planned injection site Existing peripheral neuropathy Known allergy to LA or dexamethasone.
结局指标
主要结局
To compare duration of analgesia by addition of dexamethasone to 0.5%ropivacaine to using 0.5%ropivacaine plain alone for popliteal sciatic nerve block in children undergoing foot and ankle surgeries as assessed by time to first rescue analgesic requirement
时间窗: at baseline,24hrs.
次要结局
- To compare quality of analgesia b/w two groups by adding dexamethasone to 0.5% ropivacaine than using 0.5%ropivacaine plain for popliteal sciatic nerve block in children undergoing foot and ankle surgeries using VAS score(6-12years) OPS score(0-6yrs)at rest and movement(Requirement of additional analgesia over 24hrs)