跳至主要内容
临床试验/CTRI/2024/07/070046
CTRI/2024/07/070046尚未招募Unknown

Comparison of analgesic efficacy of dexamethasone and dexmedetomidine as adjuvants to ropivacaine in ultrasound guided retrolaminar block for adult patients undergoing thoracolumbar spine surgery: a randomized controlled trial

All India Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
To compare the time to first rescue analgesic requirement in postoperative period.

研究概览

简要总结

In the landscape of thoracolumbar spine surgeries, effective perioperative pain management stands as a pivotal element in controlling post operative pain and optimizing pain relief allowing for early ambulation and decreased hospital stay. A wide of number of regional analgesia techniques have been utilised to manage this pain like paravertebral blocks, epidural blocks and interfascial blocks like erector spinae plane block.

Retrolaminar block (RLB) is a novel interfacial plane block which has been used to provide perioperative analgesia in patient undergoing lumbar surgeries, breast surgeries, nephrectomy, thoracotomy and in retroperitoneal laproscopic surgeries.  In all of these studies only local anaesthetic (bupivacaine or ropivacaine) was used. These local anaesthetics have limited duration of action typically, around 10 hours.  Several drugs (opioids, dexamethasone) have been used as adjuvants to local anaesthetics to prolong the duration of analgesia in erector spinae plane block for spine surgeries.

However, the efficacy of these adjuvants has not been established in retrolaminar plane blocks. Our study aims to determine the benefits of adding dexmedetomidine or dexamethasone as adjuvant to ropivacaine in prolonging the duration of postoperative analgesia, improve postoperative pain score and patient satisfaction.

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 60.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II patients undergoing thoracolumbar spinal surgeries less than or equal to five segments.

排除标准

  • ASA III or more Allergy to the drugs Coagulopathy Infection at puncture site Mental disorder, Communication failure, unable to discriminate cutaneous pin prick.
  • Chronic use of analgesics, inability to operate PCA pump Preexisting spinal cord disease prior lumbar spine surgery BMI more than or equal to 30.

结局指标

主要结局

To compare the time to first rescue analgesic requirement in postoperative period.

时间窗: Within 24 hours of postoperative period

次要结局

  • Total postoperative fentanyl consumption(within 24 hours of postoperative period)
  • To evaluate additional intraoperative fentanyl consumption in all groups.(From administration of block till the end of surgery)
  • Severity of pain during postoperative period(measured through NRS scale)

研究者

发起方
All India Institute of Medical Sciences Patna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Aakanksha Hiremath

AIIMS Patna

研究点 (1)

Loading locations...

相似试验