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临床试验/NCT07533760
NCT07533760已完成不适用

Comparison of the Effectiveness of Erector Spinae Plane Block Administered at Different Volumes on Postoperative Opioid Consumption and Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Prospective, Double-Blind Study

Şule Arıcan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Total Morphine Consumption

研究概览

简要总结

his study aims to investigate the effects of different volumes of ultrasound-guided erector spinae plane block (ESPB) on postoperative pain and opioid consumption in patients undergoing total abdominal hysterectomy. The researchers aim to determine whether varying the volume of local anesthetic in the ESPB can reduce the amount of morphine required by patients and improve pain scores during the first 24 hours after surgery.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged between 18 and 65 years.
  • Patients with American Society of Anesthesiologists (ASA) physical status I-III.
  • Patients scheduled to undergo elective total abdominal hysterectomy surgery.

排除标准

  • Obese patients (Body Mass Index > 30 kg/m²).
  • Patients with local skin infection at the site of needle insertion.
  • Patients with a known allergy to any of the medications used in the study.
  • Patients with coagulopathy.
  • Patients with chronic opioid consumption.
  • Patients with an inability to use the Patient-Controlled Analgesia (PCA) device.
  • Patients with advanced hepatic or renal failure.
  • Patients who refuse to participate in the study.

研究组 & 干预措施

Group I

Active Comparator

Patients in Group I received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) with 20 ml of 0.25% bupivacaine hydrochloride (prepared by combining 10 ml of 0.5% bupivacaine hydrochloride with 10 ml of saline) for each side.

干预措施: Erector Spinae Plane Block (Procedure)

Group II

Active Comparator

Patients in Group II received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) with 30 ml of 0.25% bupivacaine hydrochloride (prepared by combining 15 ml of 0.5% bupivacaine hydrochloride with 15 ml of saline) for each side.

干预措施: Erector Spinae Plane Block (Procedure)

结局指标

主要结局

Total Morphine Consumption

时间窗: First 24 hours postoperatively

The total amount of morphine (in milligrams) consumed by the patient via the Patient-Controlled Analgesia (PCA) device.

次要结局

  • Numerical Rating Scale (NRS) Scores for Pain(At postoperative 30 minutes, 2nd, 6th, 12th, and 24th hours)
  • Number of Blocked Dermatomes(20 minutes after the block procedure)

研究者

发起方
Şule Arıcan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Şule Arıcan

Associate Professor

Konya Necmettin Erbakan Üniversitesi

研究点 (1)

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