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临床试验/NCT06584695
NCT06584695尚未招募不适用

Analgesic Efficacy of External Oblique Intercostal Block Versus Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy

Cairo University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年9月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
63
试验地点
1
主要终点
Degree of pain

研究概览

简要总结

To compare the efficacy of unilateral ultrasound-guided oblique subcostal transversus abdominis plane block with unilateral ultrasound-guided external oblique intercostal plane block in providing intraoperative and postoperative analgesia in cancer patients undergoing open nephrectomy.

详细描述

Open surgery remains one of the procedures used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of severe immediate postoperative pain and chronic pain the months following surgery.

Regional anesthesia techniques are frequently recommended for pain control in open nephrectomy as they decrease the need for parenteral opioid and improve patient satisfaction.

Although abdominal wall blocks are known to decrease opioid requirements without causing epidural associated hypotension, their role in flank surgeries has been less well-established. The dermatomes that need to be covered in flank incision are T9 to T11.

Studies have confirmed that ultrasound-guided (USG) transversus abdominis plane (TAP) block is an effective method of analgesia for upper abdominal surgeries, lower abdominal surgeries and kidney transplantation with minimal side effects.

The external oblique intercostal (EOI) block is a novel method providing simple and effective somatic analgesia to the upper abdomen with minimal side effects. Other advantages include easy sonoanatomy (even in obese patients), being performed in the supine position, and no anticoagulation concern

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
All
接受健康志愿者

入选标准

  • Age (18-65) year.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) class II and III.
  • Cancer patients candidate for open nephrectomy .

排除标准

  • Patient refusal.
  • Skin lesions or infection at the site of proposed needle insertion.
  • Cognitive disorders.
  • History of psychiatric disorders or drug abuse.
  • Patients allergic to medication used.
  • ASA class IV.
  • Coagulopathy.
  • Body mass index (BMI) more than 35.

研究组 & 干预措施

Transversus abdominis plane group

Experimental

patients will receive unilateral ultrasound-guided oblique subcostal transversus abdominis plane block block

干预措施: Transversus abdominis plane block (Drug)

External oblique intercostal group

Experimental

Patients will receive unilateral ultrasound-guided external oblique intercostal block

干预措施: External Oblique Intercostal Plane Block (Drug)

Control group

Active Comparator

Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia.

干预措施: Control group (Drug)

结局指标

主要结局

Degree of pain

时间窗: 24 hours after surgery

Degree of pain by Numerical rating scale (NRS)score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable"). scores will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery, when the (NRS) was \> 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.

次要结局

  • Mean arterial pressure(Till the end of surgery (up to 2hours))
  • Heart rate(Till the end of surgery (up to 2hours))
  • Opioids consumption(24 hours after surgery)
  • Morphine consumption(24 hours after surgery.)
  • Time to rescue analgesia.(24 hours after surgery)
  • Incidence of complications(24 hours after surgery)

研究者

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

Ahmed Abdelbaset Mostafa

Specialist of Anesthesia, Surgical Intensive Care & Pain Relief

Cairo University

研究点 (1)

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