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临床试验/NCT07012590
NCT07012590已完成不适用

Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Open Subcostal Renal Surgeries

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2023年5月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
147
试验地点
1
主要终点
Degree of pain

研究概览

简要总结

This study aimed to compare the analgesic efficacy between morphine and dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided erector spinae plane block for open subcostal renal surgeries.

详细描述

The postoperative pain that occurs because of the wide flank incision ranges from a moderate to severe intensity and, in some patients, can become chronic.

The erector spinae plane block (ESPB) is a novel interfascial plane technique, aiming to block the dorsal and ventral rami of the spinal nerves to provide visceral and somatic multi-dermatomal analgesia of the cervical, thoracic, and lumbar levels.

Adjuvants to local anesthetics, such as morphine and dexmedetomidine, can be used to improve the quality and duration of peripheral nerve block effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient's approval.
  • Age: 20 - 65 years.
  • Physical Status: American Society of Anesthesiologists (ASA) I & II.
  • Patients undergoing open subcostal renal surgeries.

排除标准

  • Patient refusal.
  • Age: >65 and <20 years.
  • Allergy to Dexmedetomidine, local anesthetics, systemic opioids, and any of the drugs included in the multimodal perioperative pain protocol.
  • Patient with coagulation disorders.
  • Chronic pain syndromes and patients with chronic opioid use are defined as use of regular daily doses of systemic narcotics for the past 6 months before the surgery.
  • Body mass index of 35 kg/ m2 or more.
  • Physical Status: American Society of Anesthesiologists (ASA) III & IV.
  • Local infection or sepsis at the site of injection.

研究组 & 干预措施

Morphine group

Experimental

Patients received erector spinae plane block with morphine 2 mg as an adjuvant to bupivacaine 30 ml 0.25%.

干预措施: Morphine (Drug)

Dexmedetomidine group

Experimental

Patients received erector spinae plane block with dexmedetomidine 100 µg as an adjuvant to bupivacaine 30 ml 0.25%.

干预措施: Dexmedetomidine (Drug)

Control group

Active Comparator

Patients received erector spinae plane block with bupivacaine 30 ml 0.25% only.

干预措施: Erector spinae plane block (Other)

结局指标

主要结局

Degree of pain

时间窗: 24 hours postoperatively

The degree of pain was assessed using the Visual analogue scale (VAS) \[where (0 = no pain and 10 = severe pain)\]. VAS was evaluated at 0, 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.

次要结局

  • Time to first rescue analgesia(48 hours postoperatively)
  • Total opioid consumption(48 hours postoperatively)
  • Heart rate(48 hours postoperatively)
  • Mean arterial pressure(48 hours postoperatively)
  • Duration of sensory block(Intraoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Essam Kaka

Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Kafrelsheikh University

研究点 (1)

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