跳至主要内容
临床试验/CTRI/2024/12/078742
CTRI/2024/12/078742招募中4 期

Comparison of the efficacy of Clonidine and Dexmedetomidine as adjuvants to Ropivacaine in bilateral erector spinae plane block in patients undergoing laparoscopic cholecystectomy - A randomised controlled trial

Institute of liver and biliary sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
80
试验地点
1
主要终点
clonidine and dexmedetomidine added as adjuvants to ropivacaine for ultrasound guided erector spinae plane block in laparoscopic cholecystectomy patients, prolong the duration of analgesia and improve patient comfort.

研究概览

简要总结

Laparoscopic cholecystectomy is the gold standard for treating symptomatic gallstone disease, offering a less invasive approach that promotes early recovery and improved patient satisfaction. However, despite these benefits, postoperative pain remains significant, often leading to discomfort and limited mobility in the early recovery period. The primary sources of this pain include somatic pain from trocar insertion and visceral pain due to peritoneal stretching and diaphragmatic irritation caused by CO2 insufflation and increased intra-abdominal pressure.

Ultrasound-guided erector spinae plane block (ESPB), a periparavertebral regional block, was initially introduced for managing thoracic neuropathic pain. It has since proven effective in reducing postoperative pain in various surgeries, including ventral hernia repair, breast surgeries, thoracotomies, and lumbar fusions.

ESPB involves the ultrasound-guided injection of local anesthetic deep to the erector spinae muscle, in the paraspinal interfascial plane, offering advantages over neuraxial techniques and paravertebral blocks due to its lower risk profile and superficial application.

ESPB has shown efficacy in laparoscopic cholecystectomy, with studies exploring the role of α2 agonists like clonidine and dexmedetomidine in peripheral nerve blocks for prolonging sensory and motor blockades and analgesia. Their mechanisms include centrally mediated analgesia, direct action on peripheral nerves, attenuation of inflammatory responses, and α2 β adrenoceptor-mediated vasoconstriction.

However, their effects in fascial plane blocks are less studied. This study aims to compare the efficacy of clonidine and dexmedetomidine as adjuvants to ropivacaine in bilateral erector spinae plane blocks for laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients undergoing elective unilateral laparoscopic cholecystectomy surgery Agrees to participate in research Age
  • 65 years BMI 25.

排除标准

  • Patient refusal Failure to comprehend visual analogue scale Contraindications to intervention procedure (ESP block) History of local anaesthetic allergy Cardiovascular, respiratory, neurological or metabolic diseases, severe coagulopathy History of chronic analgesic use Failure of intervention procedures (ESP block) History of alcohol and substance addiction Known psychiatric disorders or use of psychiatric medications.

结局指标

主要结局

clonidine and dexmedetomidine added as adjuvants to ropivacaine for ultrasound guided erector spinae plane block in laparoscopic cholecystectomy patients, prolong the duration of analgesia and improve patient comfort.

时间窗: 24 hours

次要结局

  • Comparison of efficacy of clonidine and dexmedetomidine as adjuvants to 0.25% ropivacaine(Total dose of fentanyl consumption in the postoperative period)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Kondaveeti Anusha

Institute of liver and biliary sciences

研究点 (1)

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