Efficacy of ultrasound guided Quadratus lumborum block with dexmedetomidine in providing postoperative analgesia after laparoscopic surgeries in children - A randomised control trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time to first analgesic
研究概览
简要总结
Quadratus lumborum block has shown to provide longer and more effective postoperative analgesia compared with the transversus abdominis plane block and caudal block in children. Dexmedetomidine is a highly selective α2 agonist, with sympatholytic, sedative, anxiolytic and analgesic which acts by decreasing sympathetic central nervous outflow without the systemic side effects of opioids such as nausea, vomiting, respiratory depression, urinary retention, and pruritus. This study aims to evaluate effectiveness of ultrasound guided Quadratus lumborum block with dexmedetomidine as adjuvant in children undergoing Laparoscopic surgeries. The objective of study is to assess the time to first analgesic, postoperative pain scores, need for rescue analgesia, duration of block action and complications related to quadratus lumborum block with dexmedetomidine.
After obtaining Institution Ethics Committee approval - patient who fit into inclusion criteria will be enrolled into the study after obtaining informed consent from the patient’s guardian.
Patients will be randomly allocated to two groups by using computer generated random table.
GROUP A : 0.8 ml/kg of 0.25% bupivacaine for USG - guided Quadratus lumborum block with 1 mcg/kg of dexmedetomidine diluted with appropriate amount of saline
GROUP B : 0.8 ml/kg of 0.25% bupivacaine for USG – guided Quadratus lumborum block with appropriate amount of saline
Once the patient is wheeled into the holding area, baseline vitals – heart rate, oxygen saturation, blood pressure will be monitored. Block performence time, time from block given to incision, Duration of surgery will be noted down.
All children under 18 years coming for laparoscopic surgery will be premedicated with midazolam 0.5 mg/kg orally if required. Inhalational induction with Sevoflurane by mask 8% in 6L/min of O2 as FGF, IV secured. Inj. fentanyl 2 mg/kg IV, appropriate size enotracheal intubation will be done and secured after confirming air entry, anesthesia will be maintained with O2 and air and sevoflurane. Patient’s eyes will be adequately padded. Patients in both groups will received bilateral quadratus lumborum block according to the group allocation. Vitals will be monitered intraoperatively. 3 values will be recorded intraoperatively for 10 minutes post port insertion. 15mg/kg body weight Paracetamol will be given intraoperatively 30 minutes before extubation.
Postoperative pain will be assessed by FLACC scale in children upto 7 years and visual analogue scale for children from 7 years to 18 years, Postoperative sedation will be assessed by ramsey sedation score. immediately after extubation and at 5 minutes and 10 minutes post extubation, every 30 min in PACU for 2 hours and every 6 hours till 36 hours. The heart rate, pain scores and oxygen saturation will be monitored. Patients requirement of supplemental analgesic noted. FLACC or VAS Pain score more than 3 - Paracetamol 15mg/kg will be given. in case of incidence of pain within 6 hours of paracetamol, ibuprofen 7mg/kg will be given as rescue analgesic.
Routine postoperative vital data will be taken and the incidence of postoperative complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression (respiratory rate less than 10 breathes/min) will be recorded.
This study will help us promote better methods of postoperative and intraoperative analgesia and reduce opioid requirements and thereby opioid related complications in pediatric population
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •All children ASA1/2 posted for elective laparoscopic surgeries will be included in the study.
排除标准
- •History of liver and renal disorders
- •Infection at injection site
- •Allergy to local anaesthetic/ paracetamol
- •Patient and Guardian refusal.
结局指标
主要结局
Time to first analgesic
时间窗: 1. Time from block given till patient has a pain score of more than 3 is observed. | 2. Pain scores will be assessed from 0,5,10,30 minutes, 1,1.5,2,6,12,18,24,36 hours post extubation. | 3. patient has a pain score of more than 3 within 6 hours of paracetamol, he/ she | will be given Ibuprofen 7 mg/kg body weight.
次要结局
- Post operative pain scores(Every 5 minutes post extubation, at 30 minutes, 1 hour, 1 1/2 hours, 2 hours, 6 hours, 12 hours,18 hours, 24 hours, 36 hours post extubation)
- Total paracetamol doses(Total number of paracetamol doses given in the first 36 hours post block)
- Requirement of rescue analgesic(Requirement of rescue analgesic Ibuprofen 7mg/kg in addition to paracetamol if pain score more than 3 during 36 hours post block)
- Intraoperative & Postoperative complications(during intraoperative & in postoperative period Incidence of bradycardia, hypotension, respiratory depression, vomiting & pruritis will be noted)