跳至主要内容
临床试验/CTRI/2024/10/075653
CTRI/2024/10/075653尚未招募3 期

Comparative safety and efficacy of three different ultrasound guided approaches to lumbar dorsal rami for pain relief in adults undergoing lumbar spine surgery – a double blind randomized controlled non-inferiority trial.

Parnandi Bhaskar Rao1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
time from block administration to demand of first analgesia by patient after surgery

研究概览

简要总结

Lumbar spine surgery is often associated with severe pain in the perioperative period. Several regional analgesia techniques have been found to be effective in the management of pain in these group of patients [1]. Erector spinae plane block (ESPB) and thoracolumbar interfascial plane block (TLIP) are established regional approaches for effective pain management with reduction in pain scores and opioid consumption [2, 3]. Similarly, lumbar submultifidus muscle block has been introduced recently as a novel regional analgesia technique. This involves instillation of local anaesthetics below the lumbar multifidus muscle to block pain conduction through dorsal rami providing acceptable analgesia following lumbar spine surgery [4]. However, scarce information is available on the comparative safety and efficacy of these approaches for post-operative analgesia for lumbar spine surgery, hence we planned this randomized controlled trial.  

REFERENCES:

1.      Hong B, Baek S, Kang H, Oh C, Jo Y, Lee S, Park S. Regional analgesia techniques for lumbar spine surgery: a frequentist network meta-analysis. Int J Surg. 2023 Jun 1;109(6):1728-1741.

2.      Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647.

3.      Abdildin YG, Salamat A, Omarov T, Sultanova M, Krassavina Y, Viderman D. Thoracolumbar Interfascial Plane Block in Spinal Surgery: A Systematic Review with Meta-Analysis. World Neurosurg. 2023 Jun;174:52-61.

4.      Song L, Ying S, Wang Z, Yuan X. Ultrasound-guided lumbar multifidus block provides effective postoperative analgesia for lumbar spine surgery. J Clin Anesth. 2018 May;46:116-117.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • Adult ASA 1 & 2 patients undergoing lumbar spine surgery up to 4 levels with midline incision in prone position.

排除标准

  • Those who refuse to participate Sensitive to local anaesthetics Liver and Kidney failure.

结局指标

主要结局

time from block administration to demand of first analgesia by patient after surgery

时间窗: at 0, 4 and 12 hours after surgery

次要结局

  • Total tramadol consumption within 24 hours after surgery

研究者

发起方
Parnandi Bhaskar Rao
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Parnandi Bhaskar Rao

All India Institute of medical sciences, Bhubaneswar

研究点 (1)

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