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临床试验/NCT05379374
NCT05379374已完成不适用

Comparison of Analgesic Effects of Ultrasound Guided Transversus Abdominis Plane Block With Bupivacaine and Bupivacaine With Morphine in Patient Undergoing Open Unilateral Inguinal Hernia Repair Under Spinal Anaesthesia

B.P. Koirala Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年8月18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
入组人数
40
试验地点
1
主要终点
• Duration of postoperative analgesia • Postoperative analgesic requirement

研究概览

简要总结

This study is conducted to determine whether morphine added to bupivacaine in ultrasound guided (USG) transversus abdominis plane (TAP) block has beneficial effects than bupivacaine alone in providing postoperative analgesia for inguinal hernia surgery.

详细描述

Total of forty adult patients of American Society of Anaesthesiologists (ASA) physical status ( PS) I - II scheduled for elective inguinal hernia surgery under spinal anaesthesia were recruited in this study after getting written informed consent. They were randomized to undergo ipsilateral USG TAP block with 20 ml of 0.25 % bupivacaine (group B) versus 20 ml of 0.25 % bupivacaine with 3 mg morphine (group BM). Patients were followed postoperatively for the 24 hours by a blinded investigator for monitoring of number of rescue analgesic consumed, duration of analgesia, numerical rating scale (NRS) at rest and on cough and any adverse 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

  • Anaesthetic technician will prepare the study drug
  • Anaesthesiologist who is blind to the study drug will perform UG TAP block and collect data intra and post-operatively.
  • Patient will also be blind about the drug administered.

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
否

入选标准

  • •ASA I to III Elective surgery

排除标准

  • •Patient's refusal
  • •BMI > 35 kg/m2 or < 18 kg/m2
  • •Allergic or contraindication to drugs used in study
  • •Coagulopathy
  • •Local site infection
  • •Spine deformity
  • •Uncooperative or psychological illness
  • •Inability to comprehend pain scale
  • •Drugs not injected in target area

研究组 & 干预措施

Bupivacaine group

Active Comparator

0.25% bupivacaine 20 ml in TAP block

干预措施: bupivacaine and morphine (Combination Product)

Bupivacaine morphine group

Experimental

0.25% bupivacaine 20 ml with 3 mg morphine in TAP block

干预措施: bupivacaine and morphine (Combination Product)

结局指标

主要结局

• Duration of postoperative analgesia • Postoperative analgesic requirement

时间窗: Till 24 hour after surgery

Time from TAP block to first request of analgesic is considered as duration of analgesia Less requirement of rescue analgesic is considered as better

次要结局

  • • NRS for pain at rest and on cough between the groups • Any side effects(Till 24 hour after surgery)

研究者

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

Purna Kala Gurung

Principal Investigator ( Assistant Professor)

B.P. Koirala Institute of Health Sciences

研究点 (1)

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