跳至主要内容
临床试验/NCT02976597
NCT02976597已完成2 期

Morphine as an Adjunct in Sonar Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgery.

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Verbal Rating Scale Score

研究概览

简要总结

Transversus abdominis plane (TAP) block is a novel type of peripheral nerve block that involves innervations of the anterolateral abdominal wall derived from T6-L1.It provides adequate post-operative pain relieve following the various abdominal surgeries. Theoretically, TAP block may replace the need for epidural analgesia after abdominal operations. The oblique subcostal approach of the TAP (OSTAP) block, which was de¬scribed by (Hebbard et al, 2010) , has been reported to provide analgesia to the entire anterior abdomen.

详细描述

The transversus abdominis plane (TAP) technique, originally described by involves injection of local anaesthetic in the plane between the internal oblique and transversus abdominis muscle layers, with the aim of anaesthetising the intercostal nerves supplying the abdominal wall. Initially, the block used surface landmarks of the triangle of Petit (latissimus dorsi posteriorly, external oblique superiorly, iliac crest inferiorly) and a double fascial 'pop' (loss of resistance) to guide placement of the local anaesthetic. More recently, ultrasonography has been used to guide the delivery of the injectate into the appropriate plane, thereby increasing the accuracy of the Technique.

The duration of the TAB is limited to effect of administered local anesthetics. To prolong the block's duration, adjuvant medications were added to LA to magnify the effect of TAP block . Opiates such as morphine and tramadol have peripheral and central analgesic effects. Opiate receptors are present at the terminals of afferent peripheral nerves; therefore, administration of opiates peripherally might provide a significant analgesic effect.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI< 30kg/m
  • Age: 18-60 years.
  • Sex: both males and females.
  • ASA physical status: 1-II.
  • Operation: Abdominal laparotomy.

排除标准

  • Patient refusal.
  • History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
  • Coagulation disorders.
  • Allergy to study medications.
  • Chronic use of pain medications.
  • Pregnancy.
  • Respiratory tract in-fection within the last 2 weeks.
  • Heavy smoker.
  • Histo-ry of abdominal surgery or trauma.

研究组 & 干预措施

Bupivacaine 0.25%

Active Comparator

Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side on each side at end of the surgery.

干预措施: Bupivacaine 0.25% 20ml on each side Sonar guided TAB (Drug)

Morphine 10mg

Active Comparator

Morphine 10mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery.Patients will recieve 5mg morphine on each side

干预措施: Bupivacaine 0.25% 20ml on each side Sonar guided TAB (Drug)

Morphine 10mg

Active Comparator

Morphine 10mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery.Patients will recieve 5mg morphine on each side

干预措施: Morphine 10mg (Drug)

Morphine 15mg

Active Comparator

Morphine 15mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery. Patients will recieve 7.5mg morphine on each side

干预措施: Bupivacaine 0.25% 20ml on each side Sonar guided TAB (Drug)

Morphine 15mg

Active Comparator

Morphine 15mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery. Patients will recieve 7.5mg morphine on each side

干预措施: Morphine 15mg (Drug)

结局指标

主要结局

Verbal Rating Scale Score

时间窗: 24 hours

The 24 hours postoperative verbal rating scale score on cough

次要结局

  • Adverse effects(24 hours)
  • Spirometric assessment(24 hours)
  • Time to first request of rescue analgesia.(24 hours)
  • Time to first request of rescue analgesics.(24 hours)

研究者

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

Hala Saad Abdel-Ghaffar

Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Assiut University

研究点 (1)

Loading locations...

相似试验