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临床试验/CTRI/2026/02/104832
CTRI/2026/02/104832尚未招募1 期

A study to compare ultrasound guided quadratus luborum block and erector spinae block for post operative analgesia in patient undergoing percutaneous nephrolithotomy - A prospective randomised double blind study

SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年3月10日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Duration of post operative analgesia.

研究概览

简要总结

The ethical committee approval of the institute will be taken. Informed consent will be obtained from all the patients A prospective randomized double blind study. All the patients will undergo thorough preoperative evaluation, which include history taking, physical examination and relevant laboratory investigations. Patients having any of the exclusion criteria will be excluded from the study. Patients willing to be part of the study will be randomly allocated in to 2 groups which will be computer generated. Patient will be educated about VAS score in the pre operative visit. All patients will be informed about the potential benefits and complications after the study will be thoroughly explained. Standard monitors like pulse oximeter, ECG, and NIBP recording will be attached to all patients and baseline parameters such as pulse rate, blood pressure and oxygen saturation will be noted. Anaesthesia induction will be delivered with fentanyl 2mcg/kg, propofol 2mg/kg and vecuronium 0.1mg/kg, maintenance by isoflurane and 50% nitrous and 50%oxygen.Patient will be intubated with appropriate size endotracheal tube. Intravenous Ondansetron 4mg and Dexamethasone 4mg will be given to all the patients.. After administering general anaesthesia in supine position, the patient will be turned to lateral position. A total of 60 patients aged between 18 and 75 years. ASA grading 1, 2 and 3 will be selected allocated to 2 groups randomly- QLB Group: All members of this group will recive quadratus lumborum block on side of surgery. The QLB will performed by using bupivacaine 0.25% (20 ml on side of surgery). ESB Group: All members of this group will erector spinae block on side of surgery. The ESB was performed by using bupivacaine 0.25% (20 ml on side of surgery). Heart rate, blood pressure, oxygen saturation will be monitored every 5 min for initial 30 min and later on every 15 min till the end of surgery. Post operatively patient will be kept in recovery room for 2 hours. Heart rate, blood pressure, oxygen saturation will be measured and VAS score will be noted at 1,2, 4, 8, 12,16 and 24 hours after the procedure. If pain score ≥ 3, then patient will be given intravenous Paracetamol 1g iv (up to 3 doses /day). If pain persists after 30 minutes of paracetamol injection, then intravenous Tramadol 50mg will be given (up to 2 doses/day). Time from study drug injection till first dose of rescue analgesia is considered as duration of analgesia. Total number of rescue analgesic doses in 24 hours will be recorded.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age between 18-70 years.
  • ASA grade 1,2,3 Patients.

排除标准

  • Presence of contraindication to local anaesthetic agent.
  • Obese patients BMI more than 30 kg per meter square.
  • Presence of infection at injection site.

结局指标

主要结局

Duration of post operative analgesia.

时间窗: Time point A:time from study drug injection, | Time point B:6hours after surgery. | Time point c:24hours after Time point B.

次要结局

  • Post Operative pain score.(Time point B:6hours after surgery.)
  • Total analgesic drug consumption in 24 hours.(Time point C:24hours after time point C)
  • Adverse effects(Time point A:time from study drug injection,)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. RAVI BHAT

SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR DHARWAD 580009

研究点 (1)

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