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临床试验/CTRI/2025/05/086596
CTRI/2025/05/086596尚未招募4 期

To compare the effictiveness of ultrasound guided Quadratus lumborum block using injection bupivacaine and intravenous tramadol for postoperative analgesia in unilateral renal surgeries- A randomised comparative study

Mahatma Gandhi Memorial Medical college and MYHospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月18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
60
试验地点
1
主要终点
To compare the duration of postoperative analgesia in two groups.

研究概览

简要总结

INTRODUCTION

Despite advances in both surgical and anaesthesia techniques, post operative pain remains an important concern in patients undergoing renal surgeries. The postoperative pain following surgical procedures not only prolongs the duration of hospital stay but also increases morbidity and effect enhanced recovery programs. Peripheral nerve blocks and interfascial plane blocks are considered safer, providing long lasting analgesia as compared to central neuraxial blockade, and systemic analgesia (i/v, oral) facilitating lesser morbidity and early discharges. Main advantage of Quadratus lumborum block is that it provides higher dermatome coverage (T6-L1), better sensory coverage and visceral analgesia.The ultrasound is a valuable adjunct in peripheral nerve block practice due to clarity and direct visualisation of anatomical landmarks providing better and long lasting blockage with lesser complications. Hence, this study aims to evaluate the analgesic efficacy of ultrasound guided Quadratus lumborum block for postoperative analgesia in patients undergoing unilateral renal surgeries.

 METHODOLOGY

The day before surgery pre anaesthetic assessment of all patients will be done and all the patients will be explained about the NBM period, visual analogue scale (VAS score) and study protocol in their local vernacular language and written informed consent will be obtained for the same. Patients will be divided into two groups by odd and even method (30 in each group). Patients in group A will be given ultrasound guided quadratus lumborum block and patients in group B will be given Inj. Tramadol 1.5mg/kg as analgesic at the end of surgery. General anaesthesia will be standardised to all patients. Inj.Fentanyl 1mcg/kg will be administered as a top up after 60 minutes from onset of surgery.  At the end of surgery, patients of Group A will receive Quadratus lumborum block (type: anterior Shamrock’s approach) in lateral position using an ultrasound machine with a curvilinear 2-5 MHz probe using Inj. Bupivacaine 0.25% 25ml. Patients of Group B will receive Inj.Tramadol 1.5mg/kg at the end of surgery.  Haemodynamic parameters of the patient will be monitored at every 5 minutes interval till 20 minutes after giving the block and then every 20 minutes till 2 hours. After extubation, the pain will be assessed by the VAS scale of 1-10, 30 minutes post procedure till 2 hour, then at 4, 8, 12, 18, 24 hour. The patients will be administered Inj.Tramadol 1.5mg/kg if their VAS score >3 and the time duration from administration of block to VAS > 3 will be considered as duration of analgesia. The patients will be monitored from the time of extubation to 24 hours postoperatively and total consumption of Inj. Tramadol in this period will be noted. The incidence of adverse effects such as nausea, vomiting, hypotension, tachycardia etc., will be noted down and treated accordingly.

REFERENCES

1.     Venkatraman R, Saravanan R, Mohana KV, Pushparani A. Evaluation of ultrasound guided quadratus lumborum block for postoperative analgesia in unilateral laparoscopic renal surgeries – A randomised controlled trial. Indian J Anaesth 2020;64:1007-11.

2.     Sindwani G, Sahu S, Suri A, Sureka S, Thomas M. Efficacy of ultrasound guided quadratus lumborum block as postoperative analgesia in renal transplantation recipients: A randomised double blind clinical study. Indian J Anaesth 2020;64:605-10.

3.     Raman R, Prabha R. Quadratus lumborum block for patients undergoing percutaneous nephrolithotomy: A randomized controlled study. Anesth Essays Res 2021;15:174-8.

4.     Kerai, Sukhyanti; Saxena, Kirti Nath1. Quadratus lumborum block for post-caesarean analgesia. Indian Journal of Anaesthesia 61(4):p 364, April 2017. | DOI: 10.4103/ija.IJA_220_17 .

5.     Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth 2019;63:820-

6.     Sindwani G, Sahu S, Suri A, Saeed Z. Bilateral quadratus lumborum block for postoperative analgesia in a Von Hippel-Lindau syndrome patient undergoing laparoscopic radical nephrectomy. Saudi J Anaesth 2017;11:513-4.

7.     Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol 2015;32:812-8.

8.     Blanco R, Ansari T, Riad W, Shetty N. Quadratus lumborum block versus transversus abdominis plane block for postoperative pain after cesarean delivery: A randomized controlled trial. Reg Anesth Pain Med 2016;41:757-62.

9.     Krohg A, Ullensvang K, Rosseland LA, Langesæter E, Sauter AR. The analgesic effect of ultrasound-guided quadratus lumborum block after cesarean delivery: A randomized clinical trial. Anesth Analg 2018;126:559-65.

10.  Ökmen K, Ökmen BM. Ultrasound-guided anterior quadratus lumborum block for postoperative pain after percutaneous nephrolithotomy: A randomized controlled trial. Korean J Anesthesiol 2020;73:44-50.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Informed consent, Physical status ASA I, II, III and age group between 18 to 65 years.

排除标准

  • •Patient refusal, Any contraindications to regional anaesthesia and those who are allergic to local anaesthesia, Patients with coagulation abnormalities, obese patients with BMI more than 29.9 kg/m2.

结局指标

主要结局

To compare the duration of postoperative analgesia in two groups.

时间窗: To compare the duration of postoperative analgesia in two groups upto 24 hours at different time intervals.

次要结局

  • To compare the total consumption of analgesia in the first 24 hours.(Total analgesic requirement in both groups will be monitored upto 24 hours postoperatively at different time intervals depending on patient complaints.)
  • To assess complications or side effects if any.(To assess for complications like nausea, vomiting, hypotension, bradycardia if any within 24 hours postoperatively any time if they occur within 24 hours.)

研究者

发起方
Mahatma Gandhi Memorial Medical college and MYHospital
申办方类型
Government medical college

研究点 (1)

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