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临床试验/CTRI/2024/06/069068
CTRI/2024/06/069068尚未招募4 期

Comparative study between intrathecal Bupivacaine heavy and intrathecal Ropivacaine heavy in pediatric patients undergoing lower limb or lower abdominal surgeries: A Prospective Randomized double blind study

Dr Putul Kumari1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年6月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To Compare the Blockade with Bupivacaine heavy and Ropivacaine heavy that is onset, level, degree and duration of block

研究概览

简要总结

After obtaining written informed consent from parents of each patient, patients randomly allocated into 2 groups: group BF (0.5% Bupivacaine heavy with fentanyl,0.2 mcg/kg) and group RF (0.75%) Ropivacaine with Fentanyl,0.2mcg/kg) comprising 31 patients in each.  EMLA (enteric mixture of local anaesthetic) and occlusive dressing will be applied at the lumbar puncture site and venipuncture site one hour prior to surgery. Oral midazolam 0.5mg/kg with honey will be given to all patient 30 minute prior to surgery. Those patients who will not be cooperative sedation will be done by using injection ketamine 0.5 mg/kg body weight intravenously. Spinal anaesthesia will be given in L4-L5 space or L3-L4 space under all aseptic precautions with quincke cutting spinal needle 27G into two divided groups. Conventionally, SA is performed in a lateral decubitus position, with patient curled up and flexed at neck and hip joint. In paediatrics age group, care must be taken to avoid extreme neck flexion because of resultant upper airway obstruction leading to hypoxia. Both sitting and lateral positions have been found to be suitable. Depth of insertion at L4-5 varies with age (up to 5 years 15-25 mm, 5-8 years 30-40 mm). Distance from skin to subarachnoid space (mm) can be calculated by the formula {0.03 × height (cm)} or {2 × weight (kg) +7}.    Group BF will be given 0.5% Bupivacaine heavy in dose <5kg will be given 0.5-0.6mg/kg, 5-15 kg will be given 0.4 mg/kg, > 15kg will be 0.3mg/kg with fentanyl 0.2 mcg/kg.         Group RF will be given 0.75% Ropivacaine heavy in dose <5kg will be given 0.5-1mg/kg,   5-15 kg will be given 0.5mg/kg, >15kg will be given 0.5mg/kg with fentanyl 0.2mcg/kg.Caution will taken not to elevate lower extremity to avoid high or total SA.   Sensory and motor block will be assessed every 2minutes till complete   blockade. Parameters of observation

Sensory block assessment- With non traumatic in pin prick with 23G blunt   needle and facial expression or child movement will be observed.

Onset of sensory block- when patient feels dull sensation to prick or pinch   at T10 level

Time to complete sensory block –complete loss of sensation to prick or       pinch, temperature, touch and pain

Peak level- highest dermatome showing sensory blockade

Total duration of sensory block- Time interval between spinal drug injection and complete regression of sensory block upto lateral side of foot (S1). With subjective pain scale in children who express verbally and observational pain scale in children who could not express verbally

Motor block assessment- Motor blockade will be assessed by modified Bromage score

Postoperative HR, BP, SPO2 will be noted at every 3mins interval for 15mins, every 5mins for 30mins, then 15mins for 60mins, then 4hr, 6hr. Sensory and motor block will be assessed every 30 min after the surgery

Undesirable effects like nausea, vomiting, respiratory depression, pruritus, hypotension, and bradycardia will be noted. Study will be discontinued after 6hr or till complete recovery of sensory and motor function whichever is earlier.

Rescue analgesia by iv Paracetamol(15mg/kg).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
2.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • parents of patients willing to participate
  • ASA garde 1-3
  • schedule for lower extremity or lower abdominal surgery
  • operative procedure requiring spinal anaesthesia.

排除标准

  • Any contraindication to spinal anaesthesia(bleeding diathesis, infection at local site , congenital spinal anomaly )
  • patient with developmental delay
  • patient allergic to study drug.

结局指标

主要结局

To Compare the Blockade with Bupivacaine heavy and Ropivacaine heavy that is onset, level, degree and duration of block

时间窗: In Operation Theatre(zero hours)

次要结局

  • To Monitor Hemodynamic Parameter(pulse, heart rate, systolic & diastolic blood pressure , mean arterial pressure)(side effect that is bradycardia, hypotension, vomiting, respiratory depression, itching, shivering)

研究者

发起方
Dr Putul Kumari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Putul Kumari

Indira Gandhi Institute of Medical Sciences

研究点 (1)

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