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临床试验/CTRI/2025/07/090587
CTRI/2025/07/090587尚未招募4 期

Comparison of caudal epidural block 0.2 percentage ropivacaine, transverse abdominis plane block 0.5ml per kg of 0.2 percentage ropivacaine and port site infiltration of 0.4ml per kg of 0.2 percent ropivacaine for postoperative analgesia in pediatric laparoscopic surgeries

Institute of medical Sciences and SUM Hospital1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年7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
105
试验地点
1
主要终点
1.To compare post-operative analgesia using VAS scale at 0,3,5,10,15,24 hours between the 3 study groups.

研究概览

简要总结

This study is a prospective randomised clinical controlled study which will be conducted at IMS & SUM Hospital with a study population of 105 patients consisting of ASA1 & ASA 2, age group 5 -10 years posted for elective laparoscopic abdominal surgeries .

Proper consent and all the details about the procedure will be thoroughly explained to the parents and the patient.

All patients will be thoroughly examined preoperatively which includes history,general physical examination, the pre-op vitals of the patient such as blood pressure, pulse, respiratory rate, ASA grading and systemic examination.

All the patients will be nil per oral for at least 6 hours for solid,4 hours for liquid and 2 hours for clear fluid.

The routine monitors will be attached and all the preoperative baseline readings of non invasive blood pressure (NIBP),pulse rate (PR) and saturation (SP02) will be noted.

After securing an intravenous access , all the patients irrespective of the group they belong will be preloaded according to holiday segar formula with IV DNS.

Inj midazolam 0.05 mg /kg will be given as premedicaton.Inj fentanyl 2mcg/kg IV given. Induction will be done with sevoflurane. Endotracheal intubation or LMA will be put depending upon the surgery. Pressure-controlled ventilation and low fresh gas flows will be used.

GROUP CEB: candidates will be administered caudal block of 0.2% Ropivacaine at a dose decided by green Armitage formula at the sacral hiatus using USG and then confirmed by whoosh test.

GROUP TAP :candidates will be given transverse abdominal plane block under USG using 0.5ml/kg of 0.2% Ropivacaine.

GROUP PSI: candidates will be given port site infiltration of about of 0.2% Ropivacaine 0.4ml/kg given at the end of surgery at port site.

After the completion of surgery, Patient will be shifted to post anesthetic care unit.

Now all the three groups will be compared using the visual analog scale at post anesthetic care unit at interval of 0 hours,3hours, 5 hours,10 hours,15hours and 24 hours.

Along with this, time at which rescue analgesia will be required and total dose of rescue analgesia which will be required will be noted.

The post operative side effects like hypotension and urinary retention will be compared across the three groups.

Rescue analgesia(Inj paracetamol 15mg/kg IV) will be given after VAS Score >3 and if no improvement observed (inj tramadol 1-3mg/kg IV) slowly will be given.

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
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • children between 5 to 10 years undergoing laparoscopic abdominal surgeries whose parents or legal guardians have given consent.

排除标准

  • Coagulation disorder
  • Known allergy to Ropivacaine 3.Spinal malformations like spina bifida,meningomyeloceles
  • Infections at the site of block administration.

结局指标

主要结局

1.To compare post-operative analgesia using VAS scale at 0,3,5,10,15,24 hours between the 3 study groups.

时间窗: 0,3,5,10,15,24 hours

2.To compare Time, frequency and total dose of first rescue analgesia in the post operative period.

时间窗: 0,3,5,10,15,24 hours

次要结局

  • To compare the side effects of the three modes of analgesia.(0,3,5,10,15,24 hours)

研究者

发起方
Institute of medical Sciences and SUM Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Aayushi Singh

IMS and SUM Hospital

研究点 (1)

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